A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression

The University of New South Wales6 sites in 2 countries120 target enrollmentJune 2012

ConditionsUnipolar Depression Bipolar Depression

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Unipolar Depression
Sponsor: The University of New South Wales
Enrollment: 120
Locations: 6
Primary Endpoint: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

October 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of New South Wales

Responsible Party

Principal Investigator

Colleen Loo

Professor

The University of New South Wales

Eligibility Criteria

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.