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

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: Depression
• Intervention / Treatment: Device: Active tDCS + CBT; Device: Sham tDCS + CBT

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Carina, Brisbane, Queensland, Australia, 4152
      • Recruiting
      • Belmont Private Hospital
      • Contact: Sandy Sacre; Email: sandy.sacre@healthecare.com.au
      • Principal Investigator: Sandy Sacre
      • Principal Investigator: Saibal Guha

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

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)	3 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Depression and Anxiety Stress Scale	3 weeks

Collaborators and Investigators

• Sponsor: The University of New South Wales
• Collaborators: Belmont Private Hospital

Study record dates

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: Behavioral Symptoms; Depression
• Other Study ID Numbers: HC13276