NCT01562184CompletedPhase 2
A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
The University of New South Wales12 sites in 2 countries120 target enrollmentStarted: June 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 120
- Locations
- 12
- Primary Endpoint
- Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Study Overview
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 a meta-analysis. This study is a RCT of tDCS in depressed patients, testing its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and biomarkers will be measured during the trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or above.
- •Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4 weeks.
- •Total score ≥ 20 on the Montgomery-Asberg Depression Rating Scale at study entry.
Exclusion Criteria
- •Current episode duration greater than 3 years.
- •Failed more than 3 adequate antidepressant trials in current episode.
- •DSM-IV psychotic disorder.
- •Drug or alcohol abuse or dependence (preceding 3 months).
- •Inadequate response to ECT in the current episode of depression.
- •Rapid clinical response required, e.g., high suicide risk.
- •Significant acute suicide risk, defined as follows: suicide attempt within the previous 6 months that required medical treatment; or ≥ 2 suicide attempts in the past 12 months; or has a clear-cut plan for suicide and states that they cannot guarantee that they will call their regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study; or in the investigator's opinion, is likely to attempt suicide within the next 6 months.
- •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.
- •Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
Outcomes
Primary Outcomes
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame: 12 weeks
Secondary Outcomes
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)(12 weeks)
- Montreal Cognitive Assessment (MoCA): Global Cognitive Function(8 weeks)
Investigators
Colleen Loo
Professor
The University of New South Wales
Study Sites (12)
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