Transcranial Electrical Stimulation (TES) for the Treatment of Depression.

The University of New South Wales

Status: Completed

Conditions: Major Depression

Treatments: Device: Sham TES; Device: Active TES

Study type: Interventional

Funder types: Other

Identifiers

NCT01792414

HC12143

Details and patient eligibility

About

This study is a RCT of transcranial electrical stimulation in depressed patients. Mood, cognitive test performance and biomarkers will be measured during the trial.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Active TES

Active Comparator group

Description:

Active TES

Treatment:

Device: Active TES

Sham TES

Sham Comparator group

Description:

Sham TES

Treatment:

Device: Sham TES