Transcranial Electrical Stimulation (TES) for the Treatment of Depression.
Not Applicable
Completed
- Conditions
- Major Depression
- Interventions
- Device: Sham TESDevice: Active TES
- Registration Number
- NCT01792414
- Lead Sponsor
- The University of New South Wales
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham TES Sham TES Sham TES Active TES Active TES Active TES
- Primary Outcome Measures
Name Time Method Montgomery Asberg Depression Rating Scale for Depression (MADRS) 12 weeks
- Secondary Outcome Measures
Name Time Method Beck Depression Inventory II 12 weeks
Trial Locations
- Locations (1)
Black Dog Institute / University of New South Wales
🇦🇺Sydney, New South Wales, Australia