Major Depressive DisorderNCT02029963
Can Magnetic Brain Stimulation Help Prevent Relapse in Depression?
A study testing Transcranial Magnetic Stimulation (rTMS) and Treatment as Usual in people with Major Depressive Disorder, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) in helping to prevent relapse in major depressive disorder. rTMS is known to be an effective treatment for major depressive disorder, but there is also evidence that it may be effective in the maintenance of… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Transcranial Magnetic Stimulation (rTMS) and Treatment as Usual
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to 10 Nov 2021
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Major Depressive Disorder
- Patients who are not actively receiving any psychotherapy
- Patients who are on no or only one antidepressant
Who cannot join
- History of a psychotic episode
- History of neurological illness
- Previous head injury
- Active alcohol or substance abuse
- History of seizure disorders
- Currently pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Repetitive Transcranial Magnetic Stimulation in Relapse Prevention of Major Depressive Disorder
The purpose of this study is to investigate the use of repetitive transcranial magnetic stimulation (rTMS) in helping to prevent relapse in major depressive disorder. rTMS is known to be an effective treatment for major depressive disorder, but there is also evidence that it may be effective in the maintenance of remission following treatment. However, it is not yet clear what maintenance strategy will yield the best outcome in preventing relapse.
In this study, eligible patients who have finished one full course of rTMS for treatment of major depression will be randomized into three groups: (i) cluster rTMS, (ii) taper rTMS, and (iii) treatment as usual. The 'cluster rTMS' group will receive two weeks to daily rTMS six months after the completion of their regular rTMS treatment, the 'taper rTMS' group will receive three sessions a week for two weeks followed by two sessions a week for two weeks immediately following their regular rTMS treatment, while the 'treatment as usual' group will receive standard follow-up care from their own psychiatrist and/or primary care doctor.
The investigators hypothesize that the group with cluster treatment will show significantly lower relapse rates in depressive symptoms as compared to the other groups.
Read the detailed description
The purpose of this study is to investigate the efficacy of rTMS to the dorsolateral prefrontal cortex (dlPFC) as a maintenance therapy following standard rTMS treatment in major depressive disorder.
A total of 45 patients will be recruited for this study. Patients who have completed a standard six-week rTMS treatment for major depressive disorder will be randomly assigned to one of the three groups: cluster rTMS, taper rTMS, and treatment as usual. Patients in the 'cluster' group will receive two weeks of daily rTMS (10 rTMS sessions) six months after completing their rTMS treatment. Patients in the 'taper' group will receive rTMS immediately after completing rTMS treatment and the frequency of the sessions will be tapered as follows: three sessions a week for two weeks, and then two sessions a week for two weeks. The maintenance plan for patients in 'treatment as usual' group will be decided individually and may include any or all of the following: continue or start on medication, start psychotherapy and/or follow-up visits with psychiatrist or primary care provider.
Each session of rTMS will be identical: lasting about one hour and consisting of 3000 high frequency (10 Hz) pulses. After finishing their last session of rTMS treatment, all patients will be seen by the rTMS psychiatrists bi-monthly for one year. Each visit will last approximately half an hour during which time the Hamilton Depression (Ham-D) Scale will be administered.
Given the high relapse rates following rTMS treatment for depression, the investigators hope that results from this study will be very helpful to patients suffering from major depressive disorder in improving their quality of life by reducing their rate of relapse.
- Conditions
- Major Depressive Disorder
- Being tested
- Transcranial Magnetic Stimulation (rTMS), Treatment as Usual
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (rTMS)Device
A non-invasive method for brain stimulation
Treatment as UsualBehavioural
An individually-tailored maintenance plan as determined by a psychiatrist or primary care provider
| Study group | Role | What they receive |
|---|---|---|
| Cluster rTMS | Experimental | Two weeks of daily repetitive Transcranial Magnetic Stimulation (total of 10 rTMS sessions), six months following completion of regular six-week rTMS treatment. Receives: Device: Transcranial Magnetic Stimulation (rTMS) |
| Taper rTMS | Experimental | Immediately following completion of regular six-week repetitive Transcranial Magnetic Stimulation treatment, patients in this group will receive three sessions of rTMS a week for two weeks followed by two sessions of rTMS a week for two weeks (total of 10 rTMS sessions tapered in 4 weeks) Receives: Device: Transcranial Magnetic Stimulation (rTMS) |
| Treatment as Usual | Experimental | Following their last session of regular six-week rTMS treatment, patients in this group will follow an individually-tailored maintenance plan as determined by their own psychiatrist or primary care provider Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptom severity
Changes in depressive symptoms will be measured through administration of the Hamilton Depression (Ham-D) Scale.
Measured: One year with bi-monthly measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionDec 2017
- Study completion10 Nov 2021
Why it stopped: Unsuccessful in obtaining recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Responsible party
- Sponsor
- Investigators
- Mandana Modirrousta, MD PhD, Principal investigator, Saint Boniface General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029963
- Sponsor's protocol ID
- B2013:178
- Status last verified
- Sep 2021
- First submitted
- 6 Jan 2014
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Repetitive Transcranial Magnetic Stimulation in Relapse Prevention of Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02029963
- Acronym / sponsor ID
- B2013:178
- Conditions
- Major Depressive Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unsuccessful in obtaining recruitment
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Study start
- Feb 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- 10 Nov 2021 (actual)
- First posted
- 8 Jan 2014 (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 investigate the use of repetitive transcranial magnetic stimulation (rTMS) in helping to prevent relapse in major depressive disorder. rTMS is known to be an effective treatment for major depressive disorder, but there is also evidence that it may be effective in the maintenance of remission following treatment. However, it is not yet clear what maintenance strategy will yield the best outcome in preventing relapse.
In this study, eligible patients who have finished one full course of rTMS for treatment of major depression will be randomized into three groups: (i) cluster rTMS, (ii) taper rTMS, and (iii) treatment as usual. The 'cluster rTMS' group will receive two weeks to daily rTMS six months after the completion of their regular rTMS treatment, the 'taper rTMS' group will receive three sessions a week for two weeks followed by two sessions a week for two weeks immediately following their regular rTMS treatment, while the 'treatment as usual' group will receive standard follow-up care from their own psychiatrist and/or primary care doctor.
The investigators hypothesize that the group with cluster treatment will show significantly lower relapse rates in depressive symptoms as compared to the other groups.
Detailed description
The purpose of this study is to investigate the efficacy of rTMS to the dorsolateral prefrontal cortex (dlPFC) as a maintenance therapy following standard rTMS treatment in major depressive disorder.
A total of 45 patients will be recruited for this study. Patients who have completed a standard six-week rTMS treatment for major depressive disorder will be randomly assigned to one of the three groups: cluster rTMS, taper rTMS, and treatment as usual. Patients in the 'cluster' group will receive two weeks of daily rTMS (10 rTMS sessions) six months after completing their rTMS treatment. Patients in the 'taper' group will receive rTMS immediately after completing rTMS treatment and the frequency of the sessions will be tapered as follows: three sessions a week for two weeks, and then two sessions a week for two weeks. The maintenance plan for patients in 'treatment as usual' group will be decided individually and may include any or all of the following: continue or start on medication, start psychotherapy and/or follow-up visits with psychiatrist or primary care provider.
Each session of rTMS will be identical: lasting about one hour and consisting of 3000 high frequency (10 Hz) pulses. After finishing their last session of rTMS treatment, all patients will be seen by the rTMS psychiatrists bi-monthly for one year. Each visit will last approximately half an hour during which time the Hamilton Depression (Ham-D) Scale will be administered.
Given the high relapse rates following rTMS treatment for depression, the investigators hope that results from this study will be very helpful to patients suffering from major depressive disorder in improving their quality of life by reducing their rate of relapse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cluster rTMS | Experimental | Device: Transcranial Magnetic Stimulation (rTMS)Two weeks of daily repetitive Transcranial Magnetic Stimulation (total of 10 rTMS sessions), six months following completion of regular six-week rTMS treatment. |
| Taper rTMS | Experimental | Device: Transcranial Magnetic Stimulation (rTMS)Immediately following completion of regular six-week repetitive Transcranial Magnetic Stimulation treatment, patients in this group will receive three sessions of rTMS a week for two weeks followed by two sessions of rTMS a week for two weeks (total of 10 rTMS sessions tapered in 4 weeks) |
| Treatment as Usual | Experimental | Behavioral: Treatment as UsualFollowing their last session of regular six-week rTMS treatment, patients in this group will follow an individually-tailored maintenance plan as determined by their own psychiatrist or primary care provider |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Major Depressive Disorder
- Patients who are not actively receiving any psychotherapy
- Patients who are on no or only one antidepressant
Key exclusion criteria (6 listed)
- History of a psychotic episode
- History of neurological illness
- Previous head injury
- Active alcohol or substance abuse
- History of seizure disorders
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 |
|---|---|---|
| Transcranial Magnetic Stimulation (rTMS)A non-invasive method for brain stimulation | Device | Cluster rTMS, Taper rTMS |
| Treatment as UsualAn individually-tailored maintenance plan as determined by a psychiatrist or primary care provider | Behavioural | Treatment as Usual |
Primary outcome
Change in depressive symptom severity
Time frame: One year with bi-monthly measurements
Changes in depressive symptoms will be measured through administration of the Hamilton Depression (Ham-D) Scale.
Results and safety
The study was stopped early (reason given: Unsuccessful in obtaining recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
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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.
Mandana Modirrousta, MD PhD principal investigator
Saint Boniface General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (rTMS) and Treatment as Usual in people with Major Depressive Disorder, run by University of Manitoba at 1 site in Canada.
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 6 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 15 Nov 2021. 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 Canada. 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?
The study was stopped early (reason given: Unsuccessful in obtaining recruitment). 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?
Change in depressive symptom severity (time frame: One year with bi-monthly measurements). 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 15 Nov 2021.