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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active TES

Group Type ACTIVE_COMPARATOR

Active TES

Intervention Type DEVICE

Neuroconn Eldith device

Sham TES

Group Type SHAM_COMPARATOR

Sham TES

Intervention Type DEVICE

Neuroconn Eldith device

Interventions

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Sham TES

Neuroconn Eldith device

Intervention Type DEVICE

Active TES

Neuroconn Eldith device

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No