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Maintenance Transcranial Electrical Stimulation for Depression

Primary Purpose

Major Depressive Disorder, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Transcranial electrical stimulation
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, Treatment, Transcranial electrical stimulation, Maintenance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Black Dog Institute / University of New South Wales

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcranial electrical stimulation

Arm Description

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Secondary Outcome Measures

Full Information

First Posted
June 26, 2013
Last Updated
March 25, 2018
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT01890356
Brief Title
Maintenance Transcranial Electrical Stimulation for Depression
Official Title
A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Disorder
Keywords
Depression, Treatment, Transcranial electrical stimulation, Maintenance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcranial electrical stimulation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Transcranial electrical stimulation
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colleen Loo, MBBS
Organizational Affiliation
University of New South Wales
Official's Role
Principal Investigator
Facility Information:
Facility Name
Black Dog Institute / University of New South Wales
City
Randwick, Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia

12. IPD Sharing Statement

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Maintenance Transcranial Electrical Stimulation for Depression

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