CompletedInterventionalPhase 2Phase 3Updated Dec 2, 2015
Transcranial Electrical Stimulation (TES) for the Treatment of Depression. | NCT01792414 | Trialant
CompletedInterventionalNot ApplicableUpdated Feb 2, 2017
Transcranial Electrical Stimulation (TES) for the Treatment of Depression.
ClinicalTrials.gov ID
NCT01792414
Lead Sponsor
The University of New South WalesOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
70Actual
Last Update Posted
Feb 2, 2017Estimated
Start Date
Jan 2013
Primary Completion Date
Dec 2016Actual
Completion Date
Dec 2016Actual
Brief Summary
This study is a RCT of transcranial electrical stimulation in depressed patients. Mood, cognitive test performance and biomarkers will be measured during the trial.
Major Depression
Sham TES
Active TES
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.
MADRS score ≥ 20 at study entry.
Exclusion Criteria:
DSM-IV psychotic disorder;
drug or alcohol abuse or dependence (preceding 12 months);
inadequate response to ECT (current episode of depression);
anticonvulsant or benzodiazepine medication;
rapid clinical response required, e.g. 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.
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Triple
No central contacts
There are no central contacts for this study.
Black Dog Institute / University of New South Wales