Transcranial Direct Current Stimulation (tDCS) in the Treatment of Major Depressive Disorder (MDD)

February 9, 2012 updated by: Z. J. Daskalakis, Centre for Addiction and Mental Health

A Double-blind Sham Controlled Trial of Transcranial Direct Current Stimulation (tDCS) in Treating Refractory Major Depressive Disorder (MDD)

The project will investigate the use of a novel neuromodulatory technique, transcranial direct current stimulation (tDCS) in the treatment of patients with major depressive disorder.

Hypothesis 1: Active tDCS will improve depressive symptomology to a significantly greater degree than sham treatment.

Hypothesis 2: Active tDCS will be well tolerated and free of major side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Major depression is a disorder with major clinical and economic significance locally and internationally. It is a disorder of high prevalence and results in substantial disease burden and health-care costs. Critically, a significant percentage of patients, usually estimated at around 30%, fail to respond to standard treatments (Fitzgerald 2003). Techniques, such as repetitive transcranial magnetic stimulation (rTMS), are being investigated widely for the treatment of this disorder, with considerable success in recent years (Fitzgerald, Benitez et al. 2006; Hasey 2001). However, TMS equipment is expensive and requires specialized application. Additionally, TMS is associated with some side-effects (e.g. seizures). Given that depression occurs in all cultures and countries, there would be considerable value in developing a low-cost, non-invasive technique that can be applied in a wide variety of settings and which has already been shown to have some efficacy in MDD (Boggio et al. 2007).

The proposed study will be a randomized, double blind, placebo-controlled (i.e., sham stimulation vs. active tDCS), longitudinal, treatment outcome trial. Individuals with MDD will be randomized to 1 of 2 treatment conditions. These will be:

  1. Active 2mA tDCS: in this condition, 1 stimulator will be used with anodal stimulation to the left prefrontal cortex and cathodal stimulation to the right prefrontal cortex. The placement of anodal stimulation is proposed to enhance activity in the left frontal cortex; the cathode aims to reduce activity in the right prefrontal cortex.
  2. Sham treatment: the system setup is identical to that of active tDCS, but the stimulator will be turned off after 30 seconds.

A total of 15 treatments will be administered to all participants over 3 weeks (one per working day). Individuals will be randomized on a computer-generated list. Clinical raters and patients will be blind to the treatment condition. Clinical ratings well be conducted prior to and after the treatment course (i.e., after 3 weeks). All subjects randomized to sham treatment will be offered active treatment at the end of the acute treatment phase.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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
    • Ontario
      • Toronto, Ontario, Canada, M5T 1R8
        • Centre for Addiction and Mental Health

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Competent to consent
  • Have a diagnosis of Major Depressive Disorder and are currently experiencing a Major Depressive Episode as confirmed by the SCID-IV
  • Treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, at least two trials of antidepressant medication of sufficient dose for at least 6 weeks
  • Aged 18 to 75.
  • Concomitant medications including: benzodiazepines, mood stabilizers antidepressants and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.

Exclusion Criteria:

  • DSM-IV history of substance abuse or dependence in the last 6 months
  • A major and/or unstable medical or neurologic illness
  • Currently taking carbamazepine
  • Pregnancy
  • History of seizures.

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active 2mA tDCS
The stimulator will be used to deliver anodal stimulation to the left prefrontal cortex and cathodal stimulation to the right prefrontal cortex. The placement of the anode is proposed to enhance activity in the left frontal cortex; the cathode aims to reduce activity in the right prefrontal cortex.
Device: transcranial direct current stimulation (tDCS)
Delivery of mild current to specified brain regions.
Other Names:
  • Stimulator CX-6650 (Rolf Schneider Electronics, Germany)
SHAM_COMPARATOR: Sham tDCS
The system setup is identical to that of active tDCS; however, the stimulator will be turned off after 30 seconds.
Device: transcranial direct current stimulation (tDCS)
Delivery of mild current to specified brain regions.
Other Names:
  • Stimulator CX-6650 (Rolf Schneider Electronics, Germany)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Rating Scale for Depression (HAMD), 17-item version
Time Frame: Baseline and at 3 weeks
The Hamilton Depression Scale (HAMD) is a clinician administered test measuring the severity of depressive symptoms in adults and children.
Baseline and at 3 weeks

Collaborators and Investigators

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

Sponsor

Centre for Addiction and Mental Health

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

February 1, 2008

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

March 1, 2010

First Posted (ESTIMATE)

March 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 157/2007

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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