Transcranial Direct Current Stimulation as an Augmenting Intervention for Major Depression

NCT01450150 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-01-20

No results posted yet for this study

Summary

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, we 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.

Conditions

Interventions

DEVICE

Transcranial Direct Current Stimulation

20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks)

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).

Sponsors & Collaborators

  • Douglas Mental Health University Institute

    lead OTHER

Principal Investigators

  • Marcelo T. Berlim, MD, MSc · McGill University & Douglas Mental Health University Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-10-31
Completion
2018-10-31

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01450150 on ClinicalTrials.gov