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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01974076
• Other study ID #: HC13276
• Status: Recruiting
• Phase: N/A
• First received: October 27, 2013
• Last updated: December 2, 2014
• Start date: May 2014

Study information

• Verified date: December 2014
• Source: The University of New South Wales
• Contact: Sandy Sacre
• Email: sandy.sacre[@]healthecare.com.au
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics CommitteeAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Device:
• Active tDCS + CBT

• Sham tDCS + CBT

Locations

Country	Name	City	State
Australia	Belmont Private Hospital	Carina, Brisbane	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
The University of New South Wales	Belmont Private Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale for Depression (MADRS)		3 weeks
Secondary	Depression and Anxiety Stress Scale		3 weeks