Depressive Disorder, MajorNCT01909232
A Clinical Trial for the Treatment of Depression With Repetitive Transcranial Magnetic Stimulation (rTMS)
A study testing Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator and Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator in people with Depressive Disorder, Major, run by Cervel Neurotech, Inc. at 6 sites in United States.
Trial summary
The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator and Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2013to Jul 2014
- Phase
- Interventional
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current major depressive disorder (MDD)
- Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
- On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
- Weight less than 350 pounds
Who cannot join
- Current major depressive disorder episode of more than three years
- Seizure disorder
- History of brain injury, stroke or active central nervous system disease
- Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
- Active suicidal intent or plan
- Other significant psychiatric disorder
Show all 10Show fewer
- Alcohol or substance dependence or abuse
- Prior treatment with transcranial magnetic stimulation
- Have failed to clinically remit to an adequate trial of electroconvulsive therapy or vagus nerve stimulation
- If female, pregnant or lactating or planning to become pregnant within the next three months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30306
Sheppard-Pratt Health System
Baltimore, Maryland, 21285
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
Butler Hospital
Providence, Rhode Island, 02906
CRI Lifetree
Salt Lake City, Utah, 84106
About this study
Official title: A Prospective, Double-Blind, Randomized, Parallel-Group, Sham-Controlled Feasibility Trial of Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder
The purpose of this study is to determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.
- Conditions
- Depressive Disorder, Major
- Being tested
- Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator, Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator
- Keywords
- Depression, Depressive Disorder, Major depression, Major depressive disorder, MDD, Treatment resistant depression, Treatment intolerant depression, TRMD, TIMD, Transcranial Magnetic Stimulation, TMS
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder, Depressive Disorder, Treatment-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorDevice
The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.
Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorDevice
The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS treatment | Experimental | Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator Receives: Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator |
| Sham rTMS treatment | Sham comparator | Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator Receives: Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression severity
Measured by the 24-item Hamilton Rating Scale for Depression
Measured: Baseline to four weeks (the conclusion of rTMS treatment)
Secondary outcomes (8)
Change in depression severity
Measured by the 24-item Hamilton Rating Scale for Depression
Measured: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Clinically significant response
Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score
Measured: Baseline to four weeks (the conclusion of rTMS treatment)
Clinically significant response
Defined as greater than or equal to 50% decrease in the 24-item Hamilton Rating Scale for Depression score
Measured: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Remission from depression
Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10
Measured: Baseline to four weeks (the conclusion of rTMS treatment)
Remission from depression
Defined as 24-item Hamilton Rating Scale for Depression score less than or equal to 10
Measured: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Change in quality of life
Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form
Measured: Baseline to four weeks (the conclusion of rTMS treatment)
Change in quality of life
Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form
Measured: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Incidence of treatment-emergent adverse events and serious adverse events
Measured: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cervel Neurotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beth Stannard, BS, CCRP, CCRC, Study director, Cervel Neurotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909232
- Sponsor's protocol ID
- CN-CFS-TRMD-2
- Status last verified
- Jul 2016
- First submitted
- 22 Jul 2013
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blind, Randomized, Parallel-Group, Sham-Controlled Feasibility Trial of Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01909232
- Acronym / sponsor ID
- CN-CFS-TRMD-2
- Conditions
- Depressive Disorder, Major
- Keywords
- Depression, Depressive Disorder, Major depression, Major depressive disorder, MDD, Treatment resistant depression, Treatment intolerant depression, TRMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Cervel Neurotech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 26 Jul 2013 (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 determine whether the Cervel Neurotech rTMS device is safe and effective in the treatment of depression in people who do not get better with antidepressant medications or cannot take antidepressant medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS treatment | Experimental | Device: Active Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorActive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator |
| Sham rTMS treatment | Sham comparator | Device: Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorInactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current major depressive disorder (MDD)
- Resistance or intolerance to antidepressant medication in the current depressive episode, or intolerance to antidepressant medication in a past depressive episode
- On a stable psychotropic regimen prior to screening and be willing to maintain the current regimen and dosing for the duration of the study
- Weight less than 350 pounds
Key exclusion criteria (10 listed)
- Current major depressive disorder episode of more than three years
- Seizure disorder
- History of brain injury, stroke or active central nervous system disease
- Cardiac pacemaker, implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord unless deemed MRI-safe
- Active suicidal intent or plan
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 |
|---|---|---|
| Active Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorThe Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils. | Device | Active rTMS treatment |
| Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic StimulatorThe Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils. | Device | Sham rTMS treatment |
Primary outcome
Change in depression severity
Time frame: Baseline to four weeks (the conclusion of rTMS treatment)
Measured by the 24-item Hamilton Rating Scale for Depression
8 secondary outcomes
Change in depression severity
Time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Clinically significant response
Time frame: Baseline to four weeks (the conclusion of rTMS treatment)
Clinically significant response
Time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Remission from depression
Time frame: Baseline to four weeks (the conclusion of rTMS treatment)
Remission from depression
Time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Change in quality of life
Time frame: Baseline to four weeks (the conclusion of rTMS treatment)
Change in quality of life
Time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Incidence of treatment-emergent adverse events and serious adverse events
Time frame: Baseline to eight weeks (four weeks after the conclusion of rTMS treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Sponsor WebsiteLink 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.
Beth Stannard, BS, CCRP, CCRC study director
Cervel Neurotech
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator and Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator in people with Depressive Disorder, Major, run by Cervel Neurotech, Inc. at 6 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 4 inclusion and 10 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: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in depression severity (time frame: Baseline to four weeks (the conclusion of rTMS treatment)). 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 28 Jul 2016.