Maintenance Transcranial Electrical Stimulation for Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of New South Wales
Sponsor:
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01890356
First received: June 26, 2013
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Major Depressive Disorder
Bipolar Disorder
Device: Transcranial electrical stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale for Depression (MADRS) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Transcranial electrical stimulation Device: Transcranial electrical stimulation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Colleen Loo, Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01890356     History of Changes
Other Study ID Numbers: HC12499
Study First Received: June 26, 2013
Last Updated: May 30, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 01, 2014