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

The University of New South Wales70 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Major Depression

Interventions

Sham TESDEVICE

Neuroconn Eldith device

Active TESDEVICE

Neuroconn Eldith device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Black Dog Institute / University of New South Wales

Sydney, New South Wales, Australia

Outcomes

Primary Outcomes

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Time frame: 12 weeks

Secondary Outcomes

Beck Depression Inventory II

Time frame: 12 weeks

Data from ClinicalTrials.gov

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