DepressionPhase 1PROSPECTNCT00380042
Assessment of the Safety and Effectiveness of Cortical Stimulation in Subjects With Major Depressive Disorder
A Phase 1 study testing Cortical Stimulation in people with Depression and Depressive Disorder, run by Northstar Neuroscience at 3 sites in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness of cortical stimulation to the cerebral cortex of subjects who have suffered from treatment-resistant depression and have failed routine attempts at controlling their depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Disorder
- What is being tested?
- Cortical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2006to Mar 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current major depressive episode (MDE) lasting for at least two years, or at least 4 lifetime MDEs with the current episode lasting for at least one year
- Severe depression at study entry defined as a minimum score of 20 on the Hamilton Depression Rating Scale
- Failed response to at least four different antidepressant treatments
Who cannot join
- Axis I psychiatric diagnoses including schizophrenia, bipolar disorder, panic disorder, obsessive compulsive disorder, or evidence of global cognitive impairment
- An Axis II diagnoses of either: a) borderline personality disorder, or b) histrionic personality disorder
- Electroconvulsive therapy within 6 months prior to enrollment
- Known need of electroconvulsive therapy while the investigational device is implanted
- History of seizure disorder or status epilepticus
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02129
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Feasibility Study of the Safety and Effectiveness of Cortical Stimulation for Subjects With Major Depressive Disorder
The purpose of this study is to assess the safety and effectiveness of cortical stimulation to the cerebral cortex of subjects who have suffered from treatment-resistant depression and have failed routine attempts at controlling their depression.
Read the detailed description
Major depressive disorders are the most common of all psychiatric disorders. The World Health Organization estimates that 340 million people worldwide suffer from an episode of major depression each year, accounting for 4.4% of the overall global disease burden. In the United States, about 9.5% or 19 million people are affected by a depressive disorder, with a lifetime risk of about 17% for a major depressive disorder.
While depression can be effectively treated in the majority of patients by medication and psychotherapy, up to 20% of patients fail to respond. Electroconvulsive Therapy (ECT) is effective in approximately 70% of cases where antidepressant medications do not provide sufficient relief of symptoms. However, as many as 20-50% of the people who respond well to a course of ECT relapse within 6 months, therefore, periodic maintenance therapy is often required.
For those patients who are resistant to the therapies noted above, more invasive approaches have been used, including Vagus Nerve Stimulation (VNS) and more recently Deep Brain Stimulation (DBS).
Direct cortical stimulation of the cortex via an implanted device system may provide long lasting benefit with minimal side effects. The current study seeks to assess in a feasibility study the safety and efficacy of stimulating the prefrontal cortex in patients with major depressive disorder.
- Conditions
- Depression, Depressive Disorder
- Being tested
- Cortical Stimulation, Sham
- Keywords
- Cortical Electrical Stimulation, Treatment Resistant Depression, Major Depressive Disorder
- Medical subject headings
- Depression, Depressive Disorder, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortical StimulationDevice
Also called Renova Cortical Stimulation System, Northstar Depression Treatment System (DTS)
Cortical stimulation of prefrontal cortex
ShamDevice
Sham stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active Stimulation | Active comparator | Not described Receives: Device: Cortical Stimulation |
| Sham | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HDRS28)
Measured: 8 weeks after implant surgery
Secondary outcomes (1)
10-item Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: 8 weeks after implant surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionOct 2007
- Study completionMar 2009
Why it stopped: Study terminated as a result of the dissolution of the Sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northstar Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380042
- Sponsor's protocol ID
- V0479
- Acronym
- PROSPECT
- Status last verified
- Sep 2008
- First submitted
- 21 Sep 2006
- Last updated
- 31 Dec 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Safety and Effectiveness of Cortical Stimulation for Subjects With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT00380042
- Acronym / sponsor ID
- PROSPECT / V0479
- Conditions
- Depression, Depressive Disorder
- Keywords
- Cortical Electrical Stimulation, Treatment Resistant Depression, Major Depressive Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated as a result of the dissolution of the Sponsor.
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Northstar NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 25 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and effectiveness of cortical stimulation to the cerebral cortex of subjects who have suffered from treatment-resistant depression and have failed routine attempts at controlling their depression.
Detailed description
Major depressive disorders are the most common of all psychiatric disorders. The World Health Organization estimates that 340 million people worldwide suffer from an episode of major depression each year, accounting for 4.4% of the overall global disease burden. In the United States, about 9.5% or 19 million people are affected by a depressive disorder, with a lifetime risk of about 17% for a major depressive disorder.
While depression can be effectively treated in the majority of patients by medication and psychotherapy, up to 20% of patients fail to respond. Electroconvulsive Therapy (ECT) is effective in approximately 70% of cases where antidepressant medications do not provide sufficient relief of symptoms. However, as many as 20-50% of the people who respond well to a course of ECT relapse within 6 months, therefore, periodic maintenance therapy is often required.
For those patients who are resistant to the therapies noted above, more invasive approaches have been used, including Vagus Nerve Stimulation (VNS) and more recently Deep Brain Stimulation (DBS).
Direct cortical stimulation of the cortex via an implanted device system may provide long lasting benefit with minimal side effects. The current study seeks to assess in a feasibility study the safety and efficacy of stimulating the prefrontal cortex in patients with major depressive disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Stimulation | Active comparator | Device: Cortical Stimulation |
| Sham | Sham comparator | Device: Sham |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current major depressive episode (MDE) lasting for at least two years, or at least 4 lifetime MDEs with the current episode lasting for at least one year
- Severe depression at study entry defined as a minimum score of 20 on the Hamilton Depression Rating Scale
- Failed response to at least four different antidepressant treatments
Key exclusion criteria (5 listed)
- Axis I psychiatric diagnoses including schizophrenia, bipolar disorder, panic disorder, obsessive compulsive disorder, or evidence of global cognitive impairment
- An Axis II diagnoses of either: a) borderline personality disorder, or b) histrionic personality disorder
- Electroconvulsive therapy within 6 months prior to enrollment
- Known need of electroconvulsive therapy while the investigational device is implanted
- History of seizure disorder or status epilepticus
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 |
|---|---|---|
| Cortical StimulationAlso: Renova Cortical Stimulation System, Northstar Depression Treatment System (DTS)Cortical stimulation of prefrontal cortex | Device | Active Stimulation |
| ShamSham stimulation | Device | Sham |
Primary outcome
Hamilton Depression Rating Scale (HDRS28)
Time frame: 8 weeks after implant surgery
1 secondary outcome
10-item Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: 8 weeks after implant surgery
Results and safety
The study was stopped early (reason given: Study terminated as a result of the dissolution of the Sponsor.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2009.
- Click here for more information about this study: Cortical Stimulation for DepressionLink provided by the sponsor.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cortical Stimulation in people with Depression and Depressive Disorder, run by Northstar Neuroscience at 3 sites 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 5 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 31 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study terminated as a result of the dissolution of the Sponsor.). Results are not available in the source record.
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?
Hamilton Depression Rating Scale (HDRS28) (time frame: 8 weeks after implant surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2009.