Clinical trial NCT01586793: Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression
Official title: A Randomized Trial Comparing the Effectiveness and Tolerability of High and Low Frequency Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression: An Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bipolar Depression
Keywords: Repetitive transcranial magnetic stimulation
Bipolar depression
Randomized trial
rTMS
Neuromodulation
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 8
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 aim of this randomized, single-blind trial is to evaluate the effectiveness and tolerability of high frequency or low frequency repetitive transcranial magnetic stimulation (rTMS) in patients with resistant bipolar depression. Patients will be assigned to receive either high or low frequency rTMS for 20 consecutive workdays (4 weeks). 10 Hz (high) frequency rTMS and 1 Hz (low) frequency rTMS will be given over the left or right dorsolateral prefrontal cortex (DLPFC), respectively. Patients will be assessed with several psychometric instruments at baseline, and at weeks 5 and 9.


Eligibility criteria: Inclusion Criteria:

* Men or women aged 18 to 70 years
* Current major depressive episode (MDE) in the context of a bipolar disorder type I or II (according to the DSM-IV-TR) that has not improved after more than 2 adequate pharmacological trial(s) in the current episode (failure is defined as a lack of significant clinical improvement after the use of standard mood stabilizers, atypical antipsychotics and/or antidepressants given at their minimum effective dosage or higher for at least 4 weeks of duration)
* Baseline score ≥ 13 on the Quick Inventory of Depressive Symptomatology - Clinician-Administered (QIDS-C), i.e., a MDE of at least moderate intensity

Exclusion Criteria:

* Psychotic features in the current episode
* Lifetime history of a non-mood-related psychotic disorder
* Substance or alcohol abuse/dependence in the past 6 months
* Unstable medical disease (e.g., cardiovascular, renal)
* Presence of mood cycles of \< 30 days duration
* Pregnancy and/or lactation
* Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy or convulsion, metallic head implant)
* Hearing loss

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Week 5
Secondary outcomes:
measure: 21-item Hamilton Depression Rating Scale (HAM-D21)
timeFrame: Week 5
measure: Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
timeFrame: Week 5
measure: Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)
timeFrame: Week 5
measure: Montogmery-Asberg Depression Rating Scale (MADRS)
timeFrame: Week 5
Other outcomes:
Locations:
city: Verdun
country: Canada
facility: Neuromodulation Research Clinic, Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: Douglas Mental Health University Institute
name: Marcelo Berlim, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dell'Osso B, Mundo E, D'Urso N, Pozzoli S, Buoli M, Ciabatti M, Rosanova M, Massimini M, Bellina V, Mariotti M, Altamura AC. Augmentative repetitive navigated transcranial magnetic stimulation (rTMS) in drug-resistant bipolar depression. Bipolar Disord. 2009 Feb;11(1):76-81. doi: 10.1111/j.1399-5618.2008.00651.x.
citation: Dolberg OT, Dannon PN, Schreiber S, Grunhaus L. Transcranial magnetic stimulation in patients with bipolar depression: a double blind, controlled study. Bipolar Disord. 2002;4 Suppl 1:94-5. doi: 10.1034/j.1399-5618.4.s1.41.x. No abstract available.
citation: Nahas Z, Kozel FA, Li X, Anderson B, George MS. Left prefrontal transcranial magnetic stimulation (TMS) treatment of depression in bipolar affective disorder: a pilot study of acute safety and efficacy. Bipolar Disord. 2003 Feb;5(1):40-7. doi: 10.1034/j.1399-5618.2003.00011.x.