Treatment Resistant DepressionNCT03360942

Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression

A study testing SCC DBS in people with Treatment Resistant Depression and Depressive Disorder, Treatment-Resistant, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Treatment Resistant Depression, Depressive Disorder, Treatment-Resistant, Depression, Bipolar
What is being tested?: SCC DBS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2016to 30 Sep 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have received DBS for TRD
Ability to provide written informed consent
Willing to comply with all necessary study visits

Who cannot join

Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder.
Other currently active clinically significant Axis I psychiatric diagnosis including schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder. Patients with severe Axis II personality disorders will also be excluded if the personality disorder is likely to interfere with cooperation and adherence to the study protocol.
Current psychotic symptoms.
Evidence of global cognitive impairment.
Substance abuse or dependence not in full sustained remission (i.e., not active for at least one year).
Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years.

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Pregnancy or plan to become pregnant during the study period.
General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices).
Inability or unwillingness to comply with long-term follow-up.
History of intolerance to neural stimulation of any area of the body.
Participation in another drug, device or biologics trial within the preceding 30 days.
Conditions requiring repeated MRI scans.
Conditions requiring diathermy.
Conditions requiring anticoagulant medication.
Terminal illness associated with expected survival of <12 months.

Trial locations and contacts

1 site in 1 country.

United States1 site

Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03766

Other trials in United States

About this study

The long term follow up of a pilot study in which the investigators proposed to test whether high frequency stimulation of the subcallosal cingulate (SCC) is a safe and efficacious antidepressant treatment in five TRD patients, to compare the effects of left-sided vs. right-sided stimulation, and to investigate potential mechanisms of action of this intervention. Importantly, this study will be used to assess the need for and assist in planning a larger, more definitive trial of SCC Deep Brain Stimulation (DBS) for treatment-resistant depression (TRD).

Read the detailed description

The U.S. lifetime prevalence of major depressive disorder (MDD) is 17%. A number of treatments are available for depression including medications, psychotherapy and various somatic treatments. Unfortunately, up to two-thirds of patients remain symptomatic following first-line treatment and a third fail to achieve remission (defined as full resolution of depressive symptoms) after four established treatments; approximately 10%-20% of depressed patients may show virtually no improvement despite multiple, often aggressive treatments. Thus, a conservative estimate places the U.S. prevalence of treatment-resistant depression (TRD) at 1%-3%. TRD has a high risk of suicide, is a major cause of disability and is responsible for doubling of overall health care costs.

For patients with TRD there are limited evidence-based treatment options. Transcranial magnetic stimulation (TMS) may have efficacy for patients that have failed no more than one antidepressant medication 10-12, but response and remission rates are relatively low (under 30% and 20% respectively). Vagus nerve stimulation (VNS) may have efficacy in patients that have failed 4-6 antidepressant treatments but long-term response and remission rates are again low (about 20% and 10% respectively). Electroconvulsive therapy(ECT) can be effective in TRD patients with remission rates of 50%-60%. However, more than 70% of TRD patients will relapse within 6 months following a successful acute treatment course. For patients that have failed ECT, there are no evidence-based treatment options. Therefore, there is great need for novel treatment approaches for TRD.

Prior clinical trials have shown that SCC DBS has the potential to be a valuable treatment option for patients with TRD. Further developing this treatment will involve confirming its effectiveness and identifying ways to optimize its use. In this study the investigators intend to test the safety and efficacy of chronic SCC DBS as a treatment for TRD and compare the safety and efficacy of left-sided versus right-sided stimulation using a double-blind, randomized, cross-over design.

Conditions: Treatment Resistant Depression, Depressive Disorder, Treatment-Resistant, Depression, Bipolar
Being tested: SCC DBS
Medical subject headings: Depressive Disorder, Treatment-Resistant, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCC DBSDevice
Also called Libra(TM) Implantable Deep Brain Stimulation (DBS) System
Deep Brain Stimulator

Study groups in NCT03360942
Study group	Role	What they receive
DBS Long Term Follow Up	Experimental	5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years. Receives: Device: SCC DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

Device Was Functioning
Patients will be evaluated every 12 months by the study psychiatrist (via in-person, phone or video call visit) to assess device functioning,
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected from 1 to 6 years.
Mean Hamilton Depression Rating Scale (HDRS-17) Score Over Time
The Hamilton Depression Rating Scale-17 (HDRS-17) is a 17-item clinician-administered depression assessment scale pertaining to symptoms of depression experienced over the past week. For the HDRS-17, a score of 0-7 is generally accepted to be within the normal range., a score of 8-12: Possible depression, a score of 13-17: Mild depression, a score of 18-24: Moderate depression, a score of 25-52: Severe depression.
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.
Mean Hamilton Depression Rating Scale-21 (HDRS-21) Score Over Time
The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-21) is a 21-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 21 items assessing various aspects of depression, including mood, guilt, insomnia, agitation \& anxiety. Participants are rated on each item based on the presence \& severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms \& the scores from those 17 items are combined to create a total score (52 max). Higher total scores indicate more severe depression, with ranges typically interpreted as follows: a score of 0-7 is generally accepted to be within the normal range (Minimal or no depression), a score of 8-13: Mild depression, a score of 14-18: Moderate depression, a score of 19-22: Severe depression, a score of 23 and above: very severe depression. The sum of all 21 items results in highest possible score of 76.
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.
Mean Hamilton Depression Rating Scale-24 (HDRS-24) Score Over Time
The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-24) is a 24-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 24 items that assess various aspects of depression, including mood, guilt, insomnia, agitation, and anxiety. Participants are rated on each item based on the presence and severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms, and the scores from those 17 items are combined to create a total score (52 max). Higher total scores on the HDRS-24 indicate more severe depression, with ranges typically interpreted as follows: 0-7 (normal), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (sever depression) and 23 or higher (very severe depression). The sum of the scores from all 24 items results in the highest possible score being 78.
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.
Mean Hamilton Depression Rating Scale-28 (HDRS-28) Score Over Time
The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-28) is a 28-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 28 items that assess various aspects of depression, including mood, guilt, insomnia, agitation, and anxiety. Participants are rated on each item based on the presence and severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms, and the scores from those 17 items are combined to create a total score (52 max). Higher total scores on the HDRS-28 indicate more severe depression, with ranges typically interpreted as follows: 0-7 (normal), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (Sever depression) and 23 or higher (very severe depression). The sum of the scores from all 28 items results in the total score, with the highest possible score being 84.
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score Over Time
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinical assessment tool used to measure the severity of depressive symptoms in individuals diagnosed with depression. The scale consists of 10 items that assess various symptoms of depression, including apparent sadness, reported sadness, inner tension, sleep disturbances, and reduced appetite. Each item is rated on a scale from 0 to 6, with higher scores indicating more severe symptoms. The total score on the MADRS ranges from 0 to 60, with higher scores reflecting greater severity of depression. Interpretation of MADRS scores is as follows: 0-6 (normal), 7-19 (mild depression), 20-34 (moderate depression), and 35 or higher (severe depression).
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
Mean Hamilton Anxiety Rating Scale Over Time
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items, each of which assesses a different symptom of anxiety. These items cover both psychological and physical manifestations of anxiety. Each item is scored on a scale from 0 to 4, with 0 indicating the absence of the symptom and 4 indicating severe or disabling symptoms. The total score can range from 0 to 56, with higher scores indicating more severe anxiety.
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
Mean Young Mania Rating Scale (YMRS) Score Over Time
The Young Mania Rating Scale (YMRS) is a clinical assessment tool designed to measure the severity of manic symptoms in individuals diagnosed with bipolar disorder. The scale consists of an 11-item scale used to assess the severity of manic states, including elevated mood, increased energy levels, irritability, impulsivity, and grandiosity. Four items are graded on a scale of 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a scale of 0 to 4. Higher scores indicating more severe manic symptoms. The total score on the YMRS ranges from 0 to 60, with higher scores reflecting greater severity of mania. Interpretation of YMRS scores is as follows: 0-12 (normal), 13-20 (mild mania), 21-35 (moderate mania), and 36 or higher (severe mania).
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
Mean Beck Depression Inventory-II (BDI-II) Score Over Time
The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire designed to assess the severity of depressive symptoms in individuals aged 13 and older. The scale consists of 21 items that measure various symptoms of depression, such as mood, pessimism, guilt, and physical symptoms. Participants rate each item based on how they have been feeling over the past two weeks, with scores ranging from 0 to 3. Higher total scores on the BDI-II indicate more severe depressive symptoms, with ranges typically interpreted as follows: 0-13 (minimal depression), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression).
Measured: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
Mean Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) Score Over Time
The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) is a clinical assessment tool used to measure the severity of depressive symptoms in individuals diagnosed with depression. The scale consists of 16 items that assess nine criterion symptom domains of depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria. Participants rate each item based on how they have been feeling over the past seven days, with scores ranging from 0 to 3 or 0 to 4. Higher total scores on the QIDS-SR indicate more severe depressive symptoms, with ranges typically interpreted as follows: 0-5 (no depression), 6-10 (mild depression), 11-15 (moderate depression), 16-20 (severe depression), and 21-27 (very severe depression).
Measured: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or year 2 and 3 after implantation.
Mean Global Assessment of Functioning (GAF) Score Over Time
The Global Assessment of Functioning (GAF) is a single-item mental health status measure which assesses how much a person's symptoms affect their day-to-day life on a scale of 0 to 100. Higher scores indicating better overall functioning.
Measured: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
Number of Participants Reporting Suicidal Behavior or Actual Attempts Using the Columbia- Suicide Severity Rating Scale (C-SSRS) Over Time
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinical assessment tool used to evaluate the severity of suicidal ideation and behavior in individuals. The scale consists of several items that assess suicidal ideation, suicidal behavior, and the severity of suicidal intent. Scores on the C-SSRS are not summed to provide a total score; instead, each item is scored individually to assess presence, frequency, and severity of suicidal thoughts or actions.
Measured: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
Number of Participants Reporting a Specific Value in the Severity of Illness Section of the Clinical Global Impressions (CGI) Assessment
The Clinical Global Impression (CGI) is a standardized assessment tool used to provide a global evaluation of illness severity and treatment response in individuals with mental health disorders. The CGI consists of two main scales: the Clinical Global Impression-Severity (CGI-S) scale and the Clinical Global Impression-Improvement (CGI-I) scale. CGI-Scale: The CGI-S scale is used to assess the severity of illness at a specific point in time. The range of responses for the Severity of Illness section of the CGI are: Normal, not at all ill, Borderline mentally ill, Mildly ill, Moderately ill, Markedly ill, Severely ill, Among the most extremely ill patients. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the CGI.
Measured: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
Number of Participants Reporting a Specific Value in the Global Improvement Section of the Clinical Global Impressions Assessment
The Clinical Global Impression (CGI) is a standardized assessment tool used to provide a global evaluation of illness severity and treatment response in individuals with mental health disorders. The CGI consists of two main scales: the Clinical Global Impression-Severity (CGI-S) scale and the Clinical Global Impression-Improvement (CGI-I) scale. CGI-Scale: The CGI-I scale is used to assess the overall improvement or change in symptoms over time in response to treatment. The range of responses for the CGI-I are: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the CGI.
Measured: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Change Scale
The Patient Global Impression (PGI) is a self-reported assessment tool used to measure the overall severity of illness or improvement in symptoms from the patient's perspective. The potential responses to the PGI are Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse. This outcome measure reports the number of participants for whom data was available.
Measured: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Severity Scale
The potential responses to the Patient Global Impressions of Severity scale are Normal, not at all ill, Borderline mentally ill , Mildly ill, Moderately ill, Markedly ill, Severely ill, Among the most extremely ill patients. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the PGI
Measured: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 201630 Sep 2022

First posted4 Dec 2017
Study start18 Apr 2016
Primary completion30 Sep 2022
Study completion30 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03360942
Sponsor's protocol ID: D12131
Other IDs: 23442
Status last verified: Aug 2024
First submitted: 17 Aug 2017
Last updated: 12 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
RecruitingPhase 2
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruiting
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Depression, Treatment Resistant
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression

All Treatment Resistant Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Follow-up of Deep Brain Stimulation for Treatment-Resistant Depression
ClinicalTrials.gov ID: NCT03360942
Acronym / sponsor ID: D12131
Conditions: Treatment Resistant Depression, Depressive Disorder, Treatment-Resistant, Depression, Bipolar
Study type: Interventional
Recruitment status: Terminated
Enrolment: 5 participants (actual)
Lead sponsor: Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
Study start: 18 Apr 2016 (actual)
Primary completion: 30 Sep 2022 (actual)
Study completion: 30 Sep 2022 (actual)
First posted: 4 Dec 2017 (actual)
Results: Posted 12 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DBS Long Term Follow Up	Experimental	Device: SCC DBS5 participants who were in a prior study to receive DBS are enrolled to have their progress and DBS devices monitored for a period of 12 years.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Have received DBS for TRD
Ability to provide written informed consent
Willing to comply with all necessary study visits

Key exclusion criteria (15 listed)

Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder.
Other currently active clinically significant Axis I psychiatric diagnosis including schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder. Patients with severe Axis II personality disorders will also be excluded if the personality disorder is likely to interfere with cooperation and adherence to the study protocol.
Current psychotic symptoms.
Evidence of global cognitive impairment.
Substance abuse or dependence not in full sustained remission (i.e., not active for at least one year).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCC DBSAlso: Libra(TM) Implantable Deep Brain Stimulation (DBS) SystemDeep Brain Stimulator	Device	DBS Long Term Follow Up

Primary outcome

Device Was Functioning
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected from 1 to 6 years.
Patients will be evaluated every 12 months by the study psychiatrist (via in-person, phone or video call visit) to assess device functioning,
Mean Hamilton Depression Rating Scale (HDRS-17) Score Over Time
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.
The Hamilton Depression Rating Scale-17 (HDRS-17) is a 17-item clinician-administered depression assessment scale pertaining to symptoms of depression experienced over the past week. For the HDRS-17, a score of 0-7 is generally accepted to be within the normal range., a score of 8-12: Possible depression, a score of 13-17: Mild depression, a score of 18-24: Moderate depression, a score of 25-52: Severe depression.
Mean Hamilton Depression Rating Scale-21 (HDRS-21) Score Over Time
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.
The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-21) is a 21-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 21 items assessing various aspects of depression, including mood, guilt, insomnia, agitation \& anxiety. Participants are rated on each item based on the presence \& severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms \& the scores from those 17 items are combined to create a total score (52 max). Higher total scores indicate more severe depression, with ranges typically interpreted as follows: a score of 0-7 is generally accepted to be within the normal range (Minimal or no depression), a score of 8-13: Mild depression, a score of 14-18: Moderate depression, a score of 19-22: Severe depression, a score of 23 and above: very severe depression. The sum of all 21 items results in highest possible score of 76.
Mean Hamilton Depression Rating Scale-24 (HDRS-24) Score Over Time
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.
The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-24) is a 24-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 24 items that assess various aspects of depression, including mood, guilt, insomnia, agitation, and anxiety. Participants are rated on each item based on the presence and severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms, and the scores from those 17 items are combined to create a total score (52 max). Higher total scores on the HDRS-24 indicate more severe depression, with ranges typically interpreted as follows: 0-7 (normal), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (sever depression) and 23 or higher (very severe depression). The sum of the scores from all 24 items results in the highest possible score being 78.
Mean Hamilton Depression Rating Scale-28 (HDRS-28) Score Over Time
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
The Hamilton Rating Scale for Depression or Hamilton Depression Rating scale (HDRS-28) is a 28-item clinician-administered multiple-choice measure of depression symptom severity. The scale consists of 28 items that assess various aspects of depression, including mood, guilt, insomnia, agitation, and anxiety. Participants are rated on each item based on the presence and severity of symptoms, with scores ranging from 0 to 2 or 0 to 4. The first 17 items measure the severity of depressive symptoms, and the scores from those 17 items are combined to create a total score (52 max). Higher total scores on the HDRS-28 indicate more severe depression, with ranges typically interpreted as follows: 0-7 (normal), 8-13 (mild depression), 14-18 (moderate depression), 19-22 (Sever depression) and 23 or higher (very severe depression). The sum of the scores from all 28 items results in the total score, with the highest possible score being 84.
Mean Montgomery-Åsberg Depression Rating Scale (MADRS) Score Over Time
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinical assessment tool used to measure the severity of depressive symptoms in individuals diagnosed with depression. The scale consists of 10 items that assess various symptoms of depression, including apparent sadness, reported sadness, inner tension, sleep disturbances, and reduced appetite. Each item is rated on a scale from 0 to 6, with higher scores indicating more severe symptoms. The total score on the MADRS ranges from 0 to 60, with higher scores reflecting greater severity of depression. Interpretation of MADRS scores is as follows: 0-6 (normal), 7-19 (mild depression), 20-34 (moderate depression), and 35 or higher (severe depression).
Mean Hamilton Anxiety Rating Scale Over Time
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items, each of which assesses a different symptom of anxiety. These items cover both psychological and physical manifestations of anxiety. Each item is scored on a scale from 0 to 4, with 0 indicating the absence of the symptom and 4 indicating severe or disabling symptoms. The total score can range from 0 to 56, with higher scores indicating more severe anxiety.
Mean Young Mania Rating Scale (YMRS) Score Over Time
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
The Young Mania Rating Scale (YMRS) is a clinical assessment tool designed to measure the severity of manic symptoms in individuals diagnosed with bipolar disorder. The scale consists of an 11-item scale used to assess the severity of manic states, including elevated mood, increased energy levels, irritability, impulsivity, and grandiosity. Four items are graded on a scale of 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a scale of 0 to 4. Higher scores indicating more severe manic symptoms. The total score on the YMRS ranges from 0 to 60, with higher scores reflecting greater severity of mania. Interpretation of YMRS scores is as follows: 0-12 (normal), 13-20 (mild mania), 21-35 (moderate mania), and 36 or higher (severe mania).
Mean Beck Depression Inventory-II (BDI-II) Score Over Time
Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
The Beck Depression Inventory-II (BDI-II) is a self-report questionnaire designed to assess the severity of depressive symptoms in individuals aged 13 and older. The scale consists of 21 items that measure various symptoms of depression, such as mood, pessimism, guilt, and physical symptoms. Participants rate each item based on how they have been feeling over the past two weeks, with scores ranging from 0 to 3. Higher total scores on the BDI-II indicate more severe depressive symptoms, with ranges typically interpreted as follows: 0-13 (minimal depression), 14-19 (mild depression), 20-28 (moderate depression), and 29-63 (severe depression).
Mean Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) Score Over Time
Time frame: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or year 2 and 3 after implantation.
The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) is a clinical assessment tool used to measure the severity of depressive symptoms in individuals diagnosed with depression. The scale consists of 16 items that assess nine criterion symptom domains of depression according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria. Participants rate each item based on how they have been feeling over the past seven days, with scores ranging from 0 to 3 or 0 to 4. Higher total scores on the QIDS-SR indicate more severe depressive symptoms, with ranges typically interpreted as follows: 0-5 (no depression), 6-10 (mild depression), 11-15 (moderate depression), 16-20 (severe depression), and 21-27 (very severe depression).
Mean Global Assessment of Functioning (GAF) Score Over Time
Time frame: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected at 1 year after impanation or 2 years after implantation.
The Global Assessment of Functioning (GAF) is a single-item mental health status measure which assesses how much a person's symptoms affect their day-to-day life on a scale of 0 to 100. Higher scores indicating better overall functioning.
Number of Participants Reporting Suicidal Behavior or Actual Attempts Using the Columbia- Suicide Severity Rating Scale (C-SSRS) Over Time
Time frame: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
The Columbia-Suicide Severity Rating Scale (C-SSRS) is a clinical assessment tool used to evaluate the severity of suicidal ideation and behavior in individuals. The scale consists of several items that assess suicidal ideation, suicidal behavior, and the severity of suicidal intent. Scores on the C-SSRS are not summed to provide a total score; instead, each item is scored individually to assess presence, frequency, and severity of suicidal thoughts or actions.
Number of Participants Reporting a Specific Value in the Severity of Illness Section of the Clinical Global Impressions (CGI) Assessment
Time frame: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
The Clinical Global Impression (CGI) is a standardized assessment tool used to provide a global evaluation of illness severity and treatment response in individuals with mental health disorders. The CGI consists of two main scales: the Clinical Global Impression-Severity (CGI-S) scale and the Clinical Global Impression-Improvement (CGI-I) scale. CGI-Scale: The CGI-S scale is used to assess the severity of illness at a specific point in time. The range of responses for the Severity of Illness section of the CGI are: Normal, not at all ill, Borderline mentally ill, Mildly ill, Moderately ill, Markedly ill, Severely ill, Among the most extremely ill patients. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the CGI.
Number of Participants Reporting a Specific Value in the Global Improvement Section of the Clinical Global Impressions Assessment
Time frame: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
The Clinical Global Impression (CGI) is a standardized assessment tool used to provide a global evaluation of illness severity and treatment response in individuals with mental health disorders. The CGI consists of two main scales: the Clinical Global Impression-Severity (CGI-S) scale and the Clinical Global Impression-Improvement (CGI-I) scale. CGI-Scale: The CGI-I scale is used to assess the overall improvement or change in symptoms over time in response to treatment. The range of responses for the CGI-I are: Very much improved, Much improved, Minimally improved, No change, Minimally worse, Much worse, Very much worse. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the CGI.
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Change Scale
Time frame: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
The Patient Global Impression (PGI) is a self-reported assessment tool used to measure the overall severity of illness or improvement in symptoms from the patient's perspective. The potential responses to the PGI are Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse. This outcome measure reports the number of participants for whom data was available.
Number of Participants Providing a Specific Response Using the Patient Global Impressions (PGI) of Severity Scale
Time frame: Data will be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months). Data were collected at 1 year after impanation or 2 years after implantation.
The potential responses to the Patient Global Impressions of Severity scale are Normal, not at all ill, Borderline mentally ill , Mildly ill, Moderately ill, Markedly ill, Severely ill, Among the most extremely ill patients. This outcome measure reports the number of participants for whom data was available and the specific response for this section of the PGI

Results and safety

Results posted to the registry on 12 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DBS Long Term Follow Up	5	0

Primary outcome: Device Was Functioning

Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected from 1 to 6 years.. Count of participants. Unit: Participants

Measure	DBS Long Term Follow Up n = 5
Year 1: Yes Functioning	3
Year 1: No, Not Functioning	1
Year 1: Unknown (No data recorded regarding status of device)	1
Year 2: Yes Functioning	2
Year 2: No, Not Functioning	0
Year 2: Unknown (No data recorded regarding status of device)	2
Year 3: Yes Functioning	1
Year 3: No, Not Functioning	0

Population analysed: One participant had the device explanted after one year of follow-up, and thus the number analyzed dropped from 5 to 4 after the first year. After the 5th year assessment, one additional participant had the device explanted, and one participant withdrew from participation dropping the number of participants analyzed from 4 to 2. The study was closed after the sixth year.

Primary outcome: Mean Hamilton Depression Rating Scale (HDRS-17) Score Over Time

Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.. Mean (Full Range). Unit: score on a scale

Measure	DBS Long Term Follow Up n = 3
Year 1	18 (16 to 20)
Year 2	24 (24 to 24)

Population analysed: In year 1, confirmation of psychiatrist oversight or completion of assessment could not be verified for 3 of 5 participants. One participant had device explanted after year 1 and no data was collected for this participant thereafter. Data for 2 of 4 participants were not collected utilizing this tool after year 1. Confirmation of psychiatrist oversight/completion of assessment could not be verified for 1 of 2 participants for year 2. No data was collected utilizing this assessment after year 2.

Primary outcome: Mean Hamilton Depression Rating Scale-21 (HDRS-21) Score Over Time

Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.. Mean (Full Range). Unit: units on a scale

Measure	DBS Long Term Follow Up n = 3
Year 1	22 (20 to 24)
Year 2	25 (25 to 25)

Primary outcome: Mean Hamilton Depression Rating Scale-24 (HDRS-24) Score Over Time

Time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected for 1 to 2 years.. Mean (Full Range). Unit: score on a scale

Measure	DBS Long Term Follow Up n = 3
Year 1	29.5 (27 to 32)
Year 2	28 (28 to 28)

Adverse events

Time frame: Adverse events were collected from enrollment up to two years, on average. One participant had the device explanted after one year, and no adverse events were collected for this participant after the first year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DBS Long Term Follow Up	2 of 5 (40%)	5 of 5 (100%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SCC DBS in people with Treatment Resistant Depression and Depressive Disorder, Treatment-Resistant, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Was Functioning (time frame: Data was to be collected every year (approximately every 12 months) for up to 10 Years after the implantation of the device (approximately 120 months); Data were collected from 1 to 6 years.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03360942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.