Investigating tDCS as a Treatment for Unipolar and Bipolar Depression

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Unipolar Depression, Bipolar Depression

In brief

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.

Key facts

Study ID

NCT01562184

Run by

The University of New South Wales

People needed

120

Starts

2012-06-01

Expected to finish

2015-10-01

Last updated by the study team

2015-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Emory University — Atlanta, Georgia, United States
• Sheppard Pratt — Towson, Maryland, United States
• Rowan University — Cherry Hill, New Jersey, United States
• Duke University — Durham, North Carolina, United States
• University of Texas Southwestern — Dallas, Texas, United States
• University of New South Wales / Black Dog Institute — Sydney, New South Wales, Australia

Full record on ClinicalTrials.gov

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