Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression
This study is not yet open for participant recruitment.
Verified April 2012 by McGill University Health Center
Sponsor:
McGill University Health Center
Information provided by (Responsible Party):
Pablo Cervantes, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01583023
First received: April 19, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
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Purpose
The purpose of this study is to evaluate whether repetitive transcranial magnetic stimulation (rTMS) treatment is an effective adjunct treatment to lithium and bupropion.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: Bupropion Device: Repetitive Transcranial Magnetic Stimulation Other: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Assessing the Efficacy of Left Repetitive Transcranial Magnetic Stimulation (rTMS) as an Adjunctive Treatment to Antidepressants for the Treatment of Bipolar Depression |
Resource links provided by NLM:
Further study details as provided by McGill University Health Center:
Primary Outcome Measures:
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in Hamilton Depression Rating Scale (HAM-D 17) from baseline at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Change in Beck Depression Inventory (BDI-II) from baseline at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Change in Young Mania Rating Scale (YMRS) from baseline at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Wellbutrin alone |
Drug: Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 6 weeks
Other Name: Wellbutrin
|
| Experimental: Placebo + rTMS |
Device: Repetitive Transcranial Magnetic Stimulation
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.
Other: Placebo
150mg daily first week, 300mg daily thereafter for a total of 6 weeks.
|
| Experimental: Wellbutrin + rTMS |
Drug: Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 6 weeks
Other Name: Wellbutrin
Device: Repetitive Transcranial Magnetic Stimulation
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Bipolar Disorder Type I or II subjects diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) in depressed phase
- Age 18 to 65
- Rating on the Montgomery-Asberg Depression Rating Scale (MADRS) score > 20
- Rating on the Hamilton Rating Scale for Depression (HAMD-17) > 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, subject must spend at least 4 weeks at a therapeutic dose before entering the study
- Lithium monotherapy at a target dose of at least 0.7 mEq/L
- If on psychotherapy, no less than 20 sessions in the last 6 months before initiation of rTMS
Exclusion Criteria:
- 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
- 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 a dose less than or equal to 1mg/day; Lorazepam is not allowed) and hypnotics
- Previous treatment with Wellbutrin
- Abnormal lab workup results
- Subject currently enrolled in any detoxification program
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01583023
Contacts
| Contact: Pablo Cervantes, MD | 514-934-1934 ext 36109 |
Locations
| Canada, Quebec | |
| Allan Memorial Institute | Not yet recruiting |
| Montreal, Quebec, Canada | |
| Principal Investigator: Pablo Cervantes, MD | |
| Principal Investigator: Theodore Kolivakis, MD | |
| Principal Investigator: Nancy CP Low, MD | |
| Sub-Investigator: Alain Ptito, PhD | |
Sponsors and Collaborators
McGill University Health Center
Investigators
| Principal Investigator: | Pablo Cervanes, MD | McGill University Health Center |
| Principal Investigator: | Theodore Kolivakis, MD | McGill University Health Center |
| Principal Investigator: | Nancy CP Low, MD | McGill University Health Center |
More Information
No publications provided
| Responsible Party: | Pablo Cervantes, Director of the Mood Disorders Clinic, McGill University Health Center |
| ClinicalTrials.gov Identifier: | NCT01583023 History of Changes |
| Other Study ID Numbers: | RTMS-BD-1 |
| Study First Received: | April 19, 2012 |
| Last Updated: | April 19, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McGill University Health Center:
|
bipolar disorder repetitive transcranial magnetic stimulation (rtms) bupropion lithium |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents |
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013