Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression - Full Text View

Purpose

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. A total of 60 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	Intervention	Phase
Bipolar Depression	Device: Magstim Rapid2 Stimulator	Phase 2 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Depression Mental Health

U.S. FDA Resources

Further study details as provided by Douglas Mental Health University Institute:

Primary Outcome Measures:

Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
Pre-post neuromodulation treatment reduction on the scores of the MADRS

Secondary Outcome Measures:

21-item Hamilton Depression Rating Scale (HAM-D21) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
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) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
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) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
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) [ Time Frame: Week 5 ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	60
Study Start Date:	May 2012
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 10 Hz rTMS
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 Name: 1 Hz rTMS

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01586793

Locations

Canada, Quebec
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

More Information

Additional Information:

Neuromodulation Research Clinic, Douglas Mental Health University Institute This link exits the ClinicalTrials.gov site

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.

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.

Responsible Party:	MARCELO T. BERLIM, Director, Neuromodulation Research Clinic, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:	NCT01586793 History of Changes
Other Study ID Numbers:	rTMS-ERB12/05-2012
Study First Received:	April 24, 2012
Last Updated:	August 22, 2012
Health Authority:	Canada: Health Canada

Keywords provided by Douglas Mental Health University Institute:

Repetitive transcranial magnetic stimulation
Bipolar depression
Randomized trial
rTMS
Neuromodulation

Additional relevant MeSH terms:

Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic

Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 23, 2013