Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

The University of New South Wales

Status and phase

Completed

Phase 3

Phase 2

Conditions

Bipolar Depression

Unipolar Depression

Treatments

Device: Soterix tDCS device

Device: Sham tDCS device

Study type

Interventional

Funder types

Other

Identifiers

NCT01562184

HC11515

#11T-005 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.