Maintenance Transcranial Electrical Stimulation for Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890356
• Other study ID #: HC12499
• Status: Completed
• Phase: N/A
• First received: June 26, 2013
• Last updated: March 25, 2018
• Start date: June 2013
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: The University of New South Wales
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

Device:
• Transcranial electrical stimulation

Locations

Country	Name	City	State
Australia	Black Dog Institute / University of New South Wales	Randwick, Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery Asberg Depression Rating Scale for Depression (MADRS)		9 months