Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression

Depression Clinical Trial

— tDCS + CT  

Official title:

Pilot Study of Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02296437
• Other study ID #: HC14216
• Status: Recruiting
• Phase: Early Phase 1
• First received: November 18, 2014
• Last updated: October 15, 2017
• Start date: November 2014

Study information

• Verified date: October 2017
• Source: The University of New South Wales
• Contact: Donel Martin, PhD
• Phone: 61 2 9382 8353
• Email: donel.martin[@]unsw.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for treatment of depression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Participants are aged 18-65 years.

2. Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.

3. MADRS score of 20 or more.

4. Right handed

5. A history of non-response to = 2 adequate trials of antidepressant medication treatment.

Exclusion Criteria:

1. DSM-V psychotic disorder.

2. Drug or alcohol abuse or dependence (preceding 6 months).

3. Inadequate response to ECT (current episode of depression).

4. Regular benzodiazepine medication

5. Rapid clinical response required, e.g., due to high suicide risk.

6. Clinically defined neurological disorder or insult.

7. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.

8. Pregnancy.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Transcranial direct current stimulation combined with cognitive training

Locations

Country	Name	City	State
Australia	University of New South Wales	Sydney	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
The University of New South Wales	Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery and Asberg Depression Rating Scale (MADRS)		6 weeks