Bipolar DisorderPhase 4NCT01583023
Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression
A Phase 4 study testing Bupropion and Active Repetitive Transcranial Magnetic Stimulation in people with Bipolar Disorder, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation (rTMS) treatment is an effective adjunct treatment to mood stabilizers and Bupropion. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Bupropion and Active Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Apr 2015
- Phase
- Phase 4
- 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
- BD Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in depressed phase.
- Age 18 to 70. Rating on the Montgomery-Asberg Depression Rating Scale (MADRS) score > 20. Rating on the Beck Depression Inventory (BDI-II) > 20. Rating on the Young Mania Rating Scale (YMRS) < 8. Non-treated new depressive episode, at least 2 weeks in duration. If recently started on an antidepressant other than Wellbutrin, subject must spend at least 4 weeks at a therapeutic dose before entering the study.
- Lithium and epival (Sodium Valproate) in monotherapy or in combination. Novel antipsychotics can be combined with mood stabilizers for at least 4 weeks at a steady dosage prior to the study.
Who cannot join
- History of any DSM-IV Axis I diagnosis other than BD Type I or II Presence of any psychotic symptoms, characterized by a score of 3 or more on item 10 of the MADRS, a score of 6 on item 9 of the MADRS, or a score of 6 or more on item 8 of the YMRS Comorbid active dependence or substance abuse (except nicotine) Prior electroconvulsive therapy failure Pacemaker, automatic implantable defibrillator or implantable pump Aneurysm Clip Heart/Vascular Clip Prosthetic Valve Metal Prosthesis Pregnancy (must do a blood β-HCG test to exclude) Metal or metal fragments in the head Personal or Family history of seizure disorder Increased Intracranial pressure History of stroke, meningitis/encephalitis, moderate to severe traumatic brain injury, neurosurgical procedure Pharmacotherapy using any substances not mentioned in the inclusion criteria, except benzodiazepines at an equivalent dose of less than or equal to 1mg/day of lorazepam.
- Failure of previous Wellbutrin treatment. Mood disorder secondary to a medical condition. Subject currently enrolled in any detoxification program
Trial locations and contacts
1 site in 1 country.
Pablo Cervantes, MD contact
Canada1 site
Allan Memorial Institute
Montreal, Quebec
Pablo Cervantes, MD
Theodore Kolivakis, MD
About this study
Official title: Assessing the Efficacy of Left Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunctive Treatment to Mood Stabilizers for the Treatment of Bipolar Depression
The purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation (rTMS) treatment is an effective adjunct treatment to mood stabilizers and Bupropion.
- Conditions
- Bipolar Disorder
- Being tested
- Bupropion, Active Repetitive Transcranial Magnetic Stimulation, Placebo, Sham repetitive transcranial magnetic stimulation
- Keywords
- bipolar disorder, repetitive transcranial magnetic stimulation (rtms), bupropion, lithium a/o Epival
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Wellbutrin
150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
Active Repetitive Transcranial Magnetic StimulationDevice
Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 5-second trains with a 10-second inter-train interval, for 30 trains per session. This treatment will be provided for the first 4 weeks of the study.
PlaceboOther
150mg daily first week, 300mg daily thereafter for a total of 8 weeks.
Sham repetitive transcranial magnetic stimulationDevice
Sham rTMS will also begin their treatment 5 times a week for 4 weeks in junction with pharmacotherapy (Wellbutrin). Sham rTMS will be delivered at a frequency of 10 Hz and stimulation will be applied in 5-second trains with a 20-second inter-train interval, for 30 trains per session.
| Study group | Role | What they receive |
|---|---|---|
| Wellbutrin + Lithium a/o Epival + Sham rTMS | Experimental | Not described Receives: Drug: Bupropion; Device: Sham repetitive transcranial magnetic stimulation |
| Placebo + Lithium a/o Epival + Active rTMS | Experimental | Not described Receives: Device: Active Repetitive Transcranial Magnetic Stimulation; Other: Placebo |
| Wellbutrin + Lithium a/o Epival + Active rTMS | Experimental | Not described Receives: Drug: Bupropion; Device: Active Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks
Measured: 8 weeks
Secondary outcomes (5)
Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks
Measured: 8 weeks
Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks
Measured: 8 weeks
Alcohol use disorder identification test (AUDIT Assessment)
Measured: At intake
Drug abuse screen test (DAST Assessment)
Measured: At intake
Clinical Global Impression (CGI) & Analog scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startApr 2014
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pablo Cervantes, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Pablo Cervanes, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreTheodore Kolivakis, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreNancy CP Low, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreGabriella Gobbi, M.D, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583023
- Sponsor's protocol ID
- RTMS-BD-1
- Status last verified
- Mar 2014
- First submitted
- 19 Apr 2012
- Last updated
- 1 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Left Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunctive Treatment to Mood Stabilizers for the Treatment of Bipolar Depression
- ClinicalTrials.gov ID
- NCT01583023
- Acronym / sponsor ID
- RTMS-BD-1
- Conditions
- Bipolar Disorder
- Keywords
- bipolar disorder, repetitive transcranial magnetic stimulation (rtms), bupropion, lithium a/o Epival
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 23 Apr 2012 (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 evaluate whether repetitive transcranial magnetic stimulation (rTMS) treatment is an effective adjunct treatment to mood stabilizers and Bupropion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wellbutrin + Lithium a/o Epival + Sham rTMS | Experimental | Drug: Bupropion, Device: Sham repetitive transcranial magnetic stimulation |
| Placebo + Lithium a/o Epival + Active rTMS | Experimental | Device: Active Repetitive Transcranial Magnetic Stimulation, Other: Placebo |
| Wellbutrin + Lithium a/o Epival + Active rTMS | Experimental | Drug: Bupropion, Device: Active Repetitive Transcranial Magnetic Stimulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BD Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in depressed phase.
- Age 18 to 70. Rating on the Montgomery-Asberg Depression Rating Scale (MADRS) score > 20. Rating on the Beck Depression Inventory (BDI-II) > 20. Rating on the Young Mania Rating Scale (YMRS) < 8. Non-treated new depressive episode, at least 2 weeks in duration. If recently started on an antidepressant other than Wellbutrin, subject must spend at least 4 weeks at a therapeutic dose before entering the study.
- Lithium and epival (Sodium Valproate) in monotherapy or in combination. Novel antipsychotics can be combined with mood stabilizers for at least 4 weeks at a steady dosage prior to the study.
Key exclusion criteria (2 listed)
- History of any DSM-IV Axis I diagnosis other than BD Type I or II Presence of any psychotic symptoms, characterized by a score of 3 or more on item 10 of the MADRS, a score of 6 on item 9 of the MADRS, or a score of 6 or more on item 8 of the YMRS Comorbid active dependence or substance abuse (except nicotine) Prior electroconvulsive therapy failure Pacemaker, automatic implantable defibrillator or implantable pump Aneurysm Clip Heart/Vascular Clip Prosthetic Valve Metal Prosthesis Pregnancy (must do a blood β-HCG test to exclude) Metal or metal fragments in the head Personal or Family history of seizure disorder Increased Intracranial pressure History of stroke, meningitis/encephalitis, moderate to severe traumatic brain injury, neurosurgical procedure Pharmacotherapy using any substances not mentioned in the inclusion criteria, except benzodiazepines at an equivalent dose of less than or equal to 1mg/day of lorazepam.
- Failure of previous Wellbutrin treatment. Mood disorder secondary to a medical condition. Subject currently enrolled in any detoxification program
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 |
|---|---|---|
| BupropionAlso: Wellbutrin150mg daily for first week, 300mg daily thereafter for a total of 8 weeks | Drug | Wellbutrin + Lithium a/o Epival + Active rTMS, Wellbutrin + Lithium a/o Epival + Sham rTMS |
| Active Repetitive Transcranial Magnetic StimulationDaily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 5-second trains with a 10-second inter-train interval, for 30 trains per session. This treatment will be provided for the first 4 weeks of the study. | Device | Placebo + Lithium a/o Epival + Active rTMS, Wellbutrin + Lithium a/o Epival + Active rTMS |
| Placebo150mg daily first week, 300mg daily thereafter for a total of 8 weeks. | Other | Placebo + Lithium a/o Epival + Active rTMS |
| Sham repetitive transcranial magnetic stimulationSham rTMS will also begin their treatment 5 times a week for 4 weeks in junction with pharmacotherapy (Wellbutrin). Sham rTMS will be delivered at a frequency of 10 Hz and stimulation will be applied in 5-second trains with a 20-second inter-train interval, for 30 trains per session. | Device | Wellbutrin + Lithium a/o Epival + Sham rTMS |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks
Time frame: 8 weeks
5 secondary outcomes
Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks
Time frame: 8 weeks
Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks
Time frame: 8 weeks
Alcohol use disorder identification test (AUDIT Assessment)
Time frame: At intake
Drug abuse screen test (DAST Assessment)
Time frame: At intake
Clinical Global Impression (CGI) & Analog scale
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2014.
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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.
Pablo Cervantes, MD contact
Pablo Cervanes, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Theodore Kolivakis, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Nancy CP Low, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupropion and Active Repetitive Transcranial Magnetic Stimulation in people with Bipolar Disorder, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 2 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: status not confirmed, as of the sponsor's last update on 1 Apr 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pablo Cervantes, MD (514-934-1934 ext. 36109), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks (time frame: 8 weeks). 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 1 Apr 2014.