Status:
COMPLETED
Trial of Bilateral tDCS for Depression
Lead Sponsor:
The University of New South Wales
Conditions:
Depression
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and ...
Eligibility Criteria
Inclusion
- Participant meets criteria for a DSM-IV Major Depressive episode.
- MADRS score of 20 or more.
Exclusion
- Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
- History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
- Inadequate response to ECT in the current episode of depression.
- Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
- Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.
- Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.
- Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
- Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
- Participants who are not fluent in English will not be included in the trial for safety reasons.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01849367
Start Date
May 1 2013
End Date
July 1 2015
Last Update
September 17 2015
Active Locations (1)
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1
Black Dog Institute / University of New South Wales
Sydney, New South Wales, Australia, 2031