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Maintenance Transcranial Electrical Stimulation for Depression

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ClinicalTrials.gov Identifier: NCT01890356
Recruitment Status : Recruiting
First Posted : July 1, 2013
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales

Brief Summary:
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.

Condition or disease Intervention/treatment
Major Depressive Disorder Bipolar Disorder Device: Transcranial electrical stimulation

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression
Study Start Date : June 2013
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Transcranial electrical stimulation Device: Transcranial electrical stimulation



Primary Outcome Measures :
  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01890356


Contacts
Contact: Angelo Alonzo, PhD 61-2-93823720 a.alonzo@unsw.edu.au
Contact: Donel Martin, PhD 61-2-93829261 donel.martin@unsw.edu.au

Locations
Australia, New South Wales
Black Dog Institute / University of New South Wales Recruiting
Randwick, Sydney, New South Wales, Australia, 2031
Sponsors and Collaborators
The University of New South Wales
Investigators
Principal Investigator: Colleen Loo, MBBS University of New South Wales

Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01890356     History of Changes
Other Study ID Numbers: HC12499
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Colleen Loo, The University of New South Wales:
Depression
Treatment
Transcranial electrical stimulation
Maintenance

Additional relevant MeSH terms:
Disease
Depression
Depressive Disorder
Depressive Disorder, Major
Bipolar Disorder
Pathologic Processes
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders