Maintenance Transcranial Electrical Stimulation for Depression

March 25, 2018 updated by: Colleen Loo, The University of New South Wales

A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, Sydney, New South Wales, Australia, 2031
        • Black Dog Institute / University of New South Wales

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcranial electrical stimulation
Device: Transcranial electrical stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Investigators

  • Principal Investigator: Colleen Loo, MBBS, University of New South Wales

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

March 25, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC12499

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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