Maintenance Transcranial Electrical Stimulation for Depression

This study is currently recruiting participants.
Verified June 2013 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: NA
Last verified: June 2013
History: No changes posted
  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
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: June 26, 2013
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:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 22, 2014