Maintenance Transcranial Electrical Stimulation for Depression

NCT ID: NCT01890356

Last Updated: 2018-03-27

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2018-02-28

Brief Summary

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Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. This study will investigate ways of using TES as a maintenance treatment to prevent relapse in depression.

Detailed Description

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Conditions

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Major Depressive Disorder Bipolar Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transcranial electrical stimulation

Group Type EXPERIMENTAL

Transcranial electrical stimulation

Intervention Type DEVICE

Interventions

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Transcranial electrical stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All participants will be ≥ 18 years old.
* Participants must have experienced a significant clinical response, defined as ≥ 50% decrease from baseline scores on the Montgomery Asberg Depression Rating Scale (MADRS).

Exclusion Criteria

* Inadequate response to acute trial of TES.
* Suicidality.
* 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 (women of childbearing age will be asked to undergo a urine pregnancy test prior to starting the study).
* Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
* Treatment for depression is changed during months 3-9 of the trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Colleen Loo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colleen Loo, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of New South Wales

Locations

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Black Dog Institute / University of New South Wales

Randwick, Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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HC12499

Identifier Type: -

Identifier Source: org_study_id

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