Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

November 30, 2015 updated by: Colleen Loo, The University of New South Wales

A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression

Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2031
        • University of New South Wales / Black Dog Institute
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Maryland
      • Towson, Maryland, United States, 21285
        • Sheppard Pratt
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08002
        • Rowan University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or above.
  • Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks.
  • Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.

Exclusion Criteria:

  • Current episode duration greater than 3 years.
  • Failed more than 3 adequate antidepressant trials in current episode.
  • DSM-IV psychotic disorder.
  • Drug or alcohol abuse or dependence (preceding 3 months).
  • Inadequate response to ECT in the current episode of depression.
  • Rapid clinical response required, e.g., high suicide risk.
  • Significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months.
  • Clinically defined neurological disorder or insult.
  • Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  • Pregnancy.
  • Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham tDCS
Device: Sham tDCS device
Sham tDCS
Active Comparator: Active tDCS
Device: Soterix tDCS device
Active tDCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time Frame: 12 weeks
12 weeks
Montreal Cognitive Assessment (MoCA): Global Cognitive Function
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

The University of New South Wales

Collaborators

Emory University
Duke University
University of Texas
Sheppard Pratt Health System
University of Medicine and Dentistry of New Jersey

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

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

June 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 21, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2015

Last Update Submitted That Met QC Criteria

November 30, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC11515
  • #11T-005 (Other Grant/Funding Number: Stanley Medical Research Institute)

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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