Status:
UNKNOWN
Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression
Lead Sponsor:
The University of New South Wales
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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 o...
Eligibility Criteria
Inclusion
- Participants are aged 18-65 years.
- 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.
- MADRS score of 20 or more.
- Right handed
- A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment.
Exclusion
- DSM-V psychotic disorder.
- Drug or alcohol abuse or dependence (preceding 6 months).
- Inadequate response to ECT (current episode of depression).
- Regular benzodiazepine medication
- Rapid clinical response required, e.g., due to high suicide risk.
- Clinically defined neurological disorder or insult.
- Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- Pregnancy.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02296437
Start Date
November 1 2014
Last Update
October 17 2017
Active Locations (1)
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1
University of New South Wales
Sydney, New South Wales, Australia, 2031