Clinical trial NCT01583023: Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: bipolar disorder
repetitive transcranial magnetic stimulation (rtms)
bupropion
lithium a/o Epival
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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.

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 (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

Primary outcomes:
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) from baseline at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks
timeFrame: 8 weeks
measure: Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks
timeFrame: 8 weeks
measure: Alcohol use disorder identification test (AUDIT Assessment)
timeFrame: At intake
measure: Drug abuse screen test (DAST Assessment)
timeFrame: At intake
measure: Clinical Global Impression (CGI) & Analog scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Allan Memorial Institute
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Pablo Cervanes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Theodore Kolivakis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Nancy CP Low, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Gabriella Gobbi, M.D
role: PRINCIPAL_INVESTIGATOR
References: