Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression

This study has been withdrawn prior to enrollment.
(Partial funding)
Sponsor:
Information provided by (Responsible Party):
MARCELO T. BERLIM, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier:
NCT01450150
First received: October 9, 2011
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

Transcranial direct current stimulation (tDCS) is a noninvasive method to activate or de-activate neurons in superficial regions of the brain through the induction of weak electric currents in the brain tissue delivered by two scalp electrodes. Initial studies have shown tDCS to be effective for treating major depressive disorder (MDD), although there are negative trials in the specialized literature. One reason for these discrepant results might be that the duration of tDCS treatment in clinical trials to date (up to 2 weeks) is still insufficient to produce consistent clinical improvements. Thus, the investigators intend to assess, in a sample of outpatients with MDD, whether a 3-week adjunctive course of active tDCS over the left dorsolateral prefrontal cortex is associated with a significant clinical improvement when compared to sham tDCS. The investigators hypothesize that subjects receiving active tDCS will present with significantly higher response and remission rates at weeks 3.


Condition Intervention Phase
Major Depressive Disorder
Device: Transcranial Direct Current Stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation (tDCS) as an Augmenting Intervention for Treatment-Resistant Major Depression: A Randomized, Double-Blind and Sham-Controlled Trial

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Quick Inventory for Depressive Symptomatology - Clinician (QIDS-C) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response to treatment is defined as a ≥ 50% reduction in pretreatment symptoms severity at as measured by the mean QIDS-C score. Remission is defined as a QIDS-C score ≤ 5


Secondary Outcome Measures:
  • 21-item Hamilton Depression Rating Scale (HAM-D21) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response to treatment is defined as a ≥ 50% reduction in the scores of the HAM-D21. Remission is defined as a HAM-D21 score ≤ 8

  • Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR) [ Time Frame: week 4 ] [ Designated as safety issue: No ]
    Response is defined as a ≥ 50% reduction in the scores of the QIDS-SR. Remission is defined as a QIDS-SR score ≤ 5


Enrollment: 0
Study Start Date: October 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active tDCS Device: Transcranial Direct Current Stimulation
20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks)
Sham Comparator: Sham tDCS Device: Transcranial Direct Current Stimulation
The tDCS stimulator will be turned on for 30 seconds only, after which it will be gradually decreased and then turned off for the remainder of the 20-minute daily sessions for 15 days (Monday to Friday on three consecutive weeks).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of a current major depressive disorder (according to the Diagnostic and Statistical Manual, Fourth Edition, Text Revision [DSM-IV-TR])
  • Baseline score ≥ 13 on the QIDS-C
  • Stable medication regimen (> 4 weeks)

Exclusion Criteria:

  • Psychotic features in the current episode
  • Lifetime history of psychotic disorders and/or bipolar I or II disorders
  • Substance or alcohol abuse/dependence in the past 6 months
  • Lifetime history of a major neurological disease (e.g., Parkinson's, stroke)
  • Uncontrolled medical disease (e.g., cardiovascular, renal)
  • Pregnancy and/or lactation
  • Presence of a specific contraindication for tDCS (e.g., personal history of epilepsy, metallic head implant, cardiac pacemaker)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01450150

Locations
Canada, Quebec
Douglas Mental Health University Institute
Montreal, Quebec, Canada, H4H1R3
Sponsors and Collaborators
Douglas Mental Health University Institute
Investigators
Principal Investigator: Marcelo T. Berlim, MD, MSc McGill University & Douglas Mental Health University Institute
  More Information

Additional Information:
Publications:
Responsible Party: MARCELO T. BERLIM, Director, Neuromodulation Research Clinic, Douglas Mental Health University Institute
ClinicalTrials.gov Identifier: NCT01450150     History of Changes
Other Study ID Numbers: tDCS-ERB08/04-2011
Study First Received: October 9, 2011
Last Updated: September 7, 2012
Health Authority: Canada: Health Canada

Keywords provided by Douglas Mental Health University Institute:
Major Depression
Transcranial Direct Current Stimulation
Randomized, Sham-Controlled Trial
tDCS

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014