Repetitive Transcranial Magnetic Stimulation for Treating Resistant Bipolar Depression

May 26, 2015 updated by: MARCELO T. BERLIM, Douglas Mental Health University Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Verdun, Quebec, Canada, H4H1R3
        • Neuromodulation Research Clinic, Douglas Mental Health University Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.
Other Names:
  • 1 Hz rTMS
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:
  • 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 Names:
  • 1 Hz rTMS
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:
  • 10 Hz rTMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Week 5
Pre-post neuromodulation treatment reduction on the scores of the MADRS
Week 5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
21-item Hamilton Depression Rating Scale (HAM-D21)
Time Frame: 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.
Week 5
Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
Time Frame: 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.
Week 5
Quick Inventory of Depressive Symptomatology - Clinician (QIDS-C)
Time Frame: 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.
Week 5
Montogmery-Asberg Depression Rating Scale (MADRS)
Time Frame: 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.
Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Douglas Mental Health University Institute

Investigators

  • Principal Investigator: Marcelo Berlim, MD, MSc, Douglas Mental Health University Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 24, 2012

First Submitted That Met QC Criteria

April 25, 2012

First Posted (Estimate)

April 27, 2012

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rTMS-ERB12/05-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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