NCT01890356

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2013

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

4.7 years

First QC Date

June 26, 2013

Last Update Submit

March 25, 2018

Conditions

Major Depressive DisorderBipolar Disorder

Keywords

DepressionTreatmentTranscranial electrical stimulationMaintenance

Outcome Measures

Primary Outcomes (1)

  • Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    9 months

Study Arms (1)

Transcranial electrical stimulation

EXPERIMENTAL
Device: Transcranial electrical stimulation

Interventions

Transcranial electrical stimulationDEVICE
Transcranial electrical stimulation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Black Dog Institute / University of New South Wales

Randwick, Sydney, New South Wales, 2031, Australia

Location

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderDepression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Colleen Loo, MBBS

    University of New South Wales

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2013

First Posted

July 1, 2013

Study Start

June 1, 2013

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations

AU(1)