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

Not Applicable

• Conditions: Depression
• Interventions: Device: Active tDCS + CBT; Device: Sham tDCS + CBT

• Registration Number: NCT01974076
• Lead Sponsor: The University of New South Wales

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-10-27
• Study First Submitted QC: 2013-10-27
• Study First Posted: 2013-11-01
• Study Start: 2014-05
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-04
• Primary Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Active tDCS + CBT	-
Sham tDCS	Sham tDCS + CBT	-

Primary Outcome Measures

Name	Time	Method
Montgomery Asberg Depression Rating Scale for Depression (MADRS)	3 weeks

Secondary Outcome Measures

Name	Time	Method
Depression and Anxiety Stress Scale	3 weeks

Trial Locations

Locations (1)

Belmont Private Hospital; 🇦🇺 Carina, Brisbane, Queensland, Australia