Using Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Bipolar Depression

This study is not yet open for participant recruitment.
Verified March 2014 by McGill University Health Center
Sponsor:
Information provided by (Responsible Party):
Pablo Cervantes, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01583023
First received: April 19, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Drug: Bupropion
Device: Active Repetitive Transcranial Magnetic Stimulation
Other: Placebo
Device: Sham repetitive transcranial magnetic stimulation
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 Mood Stabilizers 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 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in Beck Depression Inventory (BDI-II) from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Change in Young Mania Rating Scale (YMRS) from baseline at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
  • Alcohol use disorder identification test (AUDIT Assessment) [ Time Frame: At intake ] [ Designated as safety issue: No ]
  • Drug abuse screen test (DAST Assessment) [ Time Frame: At intake ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) & Analog scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: April 2014
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Wellbutrin + Lithium a/o Epival + Sham rTMS Drug: Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
Other Name: Wellbutrin
Device: Sham repetitive transcranial magnetic stimulation
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.
Experimental: Placebo + Lithium a/o Epival + Active rTMS Device: Active 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 8 weeks.
Experimental: Wellbutrin + Lithium a/o Epival + Active rTMS Drug: Bupropion
150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
Other Name: Wellbutrin
Device: Active 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 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  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         
Principal Investigator: Gabriella Gobbi, MD         
Sub-Investigator: Maykel F.Ghabrash, MD         
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
Principal Investigator: Gabriella Gobbi, M.D 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: March 31, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by McGill University Health Center:
bipolar disorder
repetitive transcranial magnetic stimulation (rtms)
bupropion
lithium a/o Epival

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 April 17, 2014