Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

Bipolar Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586793
• Other study ID #: rTMS-ERB12/05-2012
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 24, 2012
• Last updated: May 26, 2015
• Start date: May 2012
• Est. completion date: January 2014

Study information

• Verified date: May 2015
• Source: Douglas Mental Health University Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Device:
• Magstim Rapid2 Stimulator
1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.
• 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.

Locations

Country	Name	City	State
Canada	Neuromodulation Research Clinic, Douglas Mental Health University Institute	Verdun	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Asberg Depression Rating Scale (MADRS)	Pre-post neuromodulation treatment reduction on the scores of the MADRS	Week 5	No
Secondary	21-item Hamilton Depression Rating Scale (HAM-D21)	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.	Week 5	No
Secondary	Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)	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.	Week 5	No
Secondary	Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)	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.	Week 5	No
Secondary	Montogmery-Asberg Depression Rating Scale (MADRS)	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.	Week 5	No

External Links

•   Neuromodulation Research Clinic, Douglas Mental Health University Institute