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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Z. J. Daskalakis, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01078948
First received: February 25, 2008
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Device: transcranial direct current stimulation (tDCS)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind Sham Controlled Trial of Transcranial Direct Current Stimulation (tDCS) in Treating Refractory Major Depressive Disorder (MDD)

Further study details as provided by Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HAMD), 17-item version [ Time Frame: Baseline and at 3 weeks ] [ Designated as safety issue: No ]
    The Hamilton Depression Scale (HAMD) is a clinician administered test measuring the severity of depressive symptoms in adults and children.


Enrollment: 24
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Stimulator CX-6650 (Rolf Schneider Electronics, Germany)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078948

Locations
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8
Sponsors and Collaborators
Centre for Addiction and Mental Health
Investigators
Principal Investigator: Jeff Daskalakis, MD, PhD Centre for Addiction and Mental Health
  More Information

Additional Information:
No publications provided

Responsible Party: Z. J. Daskalakis, Director, Brain Stimulation Treatment and Research Program, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01078948     History of Changes
Other Study ID Numbers: 157/2007
Study First Received: February 25, 2008
Last Updated: February 9, 2012
Health Authority: Canada: Health Canada

Keywords provided by Centre for Addiction and Mental Health:
tDCS
transcranial direct current stimulation
major depression
double-blind
randomized
placebo-controlled
treatment

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

ClinicalTrials.gov processed this record on September 18, 2014