Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: High Frequency rTMS 10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT. |
Device: Magstim Rapid2 Stimulator
10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT.
Other Names:
|
| Experimental: Low Frequency rTMS 1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT. |
Device: Magstim Rapid2 Stimulator
1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Montgomery-Asberg Depression Rating Scale (MADRS) [Week 5]
Pre-post neuromodulation treatment reduction on the scores of the MADRS
Secondary Outcome Measures
- 21-item Hamilton Depression Rating Scale (HAM-D21) [Week 5]
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean HAM-D21 score. Remission will be considered as a HAM-D21 score ≤ 8.
- Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) [Week 5]
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean QIDS-SR score. Remission will be considered as a QIDS-SR score ≤ 5.
- Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C) [Week 5]
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean QIDS-C score. Remission will be considered as a QIDS-C score ≤ 5.
- Montogmery-Asberg Depression Rating Scale (MADRS) [Week 5]
Response to treatment will be defined as a higher than 50% reduction in pretreatment symptoms severity as measured by the mean MADRS score. Remission will be defined as a MADRS score ≤ 6.
Eligibility Criteria
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)
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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:
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Psychotic features in the current episode
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Lifetime history of a non-mood-related psychotic disorder
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Substance or alcohol abuse/dependence in the past 6 months
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Unstable medical disease (e.g., cardiovascular, renal)
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Presence of mood cycles of < 30 days duration
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Pregnancy and/or lactation
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Presence of a specific contraindication for rTMS (e.g., personal history of epilepsy or convulsion, metallic head implant)
-
Hearing loss
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neuromodulation Research Clinic, Douglas Mental Health University Institute | Verdun | Quebec | Canada | H4H1R3 |
Sponsors and Collaborators
- Douglas Mental Health University Institute
Investigators
- Principal Investigator: Marcelo Berlim, MD, MSc, Douglas Mental Health University Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- rTMS-ERB12/05-2012