Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)

December 2, 2014 updated by: Colleen Loo, The University of New South Wales

A Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behavioural Therapy (CBT) for Depression

This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

135

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 Contact

Study Locations

  • Australia
    • Queensland
      • Carina, Brisbane, Queensland, Australia, 4152
        • Recruiting
        • Belmont Private Hospital
        • Contact:
        • Principal Investigator:
          • Sandy Sacre
        • Principal Investigator:
          • Saibal Guha

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:

  1. Participants will be ≥ 18 years old.
  2. Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration.
  3. MADRS score ≥ 20 at study entry.

Exclusion Criteria:

  1. Participant is unable to give informed consent.
  2. DSM-IV diagnosis of psychotic disorder (lifetime).
  3. Bipolar disorder diagnosis and not on a mood stabiliser.
  4. Eating disorder (current or within past year).
  5. Obsessive compulsive disorder (lifetime).
  6. Post-traumatic stress disorder (current or within past year).
  7. Mental retardation.
  8. Drug or alcohol abuse or dependence (preceding 3 months).
  9. Inadequate response to ECT (current episode of depression).
  10. Rapid clinical response required, e.g., high suicide risk, inanition or psychosis.
  11. Clinically defined neurological disorder or insult.
  12. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  13. Pregnancy.
  14. Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
  15. Change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial.
  16. Participant becomes hypomanic or manic, as defined by DSM-IV.

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
Sham Comparator: Sham tDCS
Device: Sham tDCS + CBT
Active Comparator: Active tDCS
Device: Active tDCS + CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame: 3 weeks
3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression and Anxiety Stress Scale
Time Frame: 3 weeks
3 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

Belmont Private Hospital

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

May 1, 2014

Primary Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

October 27, 2013

First Submitted That Met QC Criteria

October 27, 2013

First Posted (Estimate)

November 1, 2013

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC13276

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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