Maintenance Transcranial Electrical Stimulation for Depre... | NCT01890356

Studies
Maintenance Transcranial Electrical Stimulation for Depression

NCT01890356

Sponsor

The University of New South Wales

Status

Completed

Last Update Posted

Mar 27, 2018Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Major Depressive Disorder
Bipolar Disorder

Interventions

Transcranial electrical stimulation

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Feb 2018Actual

Completion Date

Feb 2018Actual

First Submitted Date

Jun 26, 2013

First Submission Date that Met QC Criteria

Jun 26, 2013

First Posted Date

Jul 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2018

Last Update Posted Date

Mar 27, 2018Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transcranial electrical stimulation	Experimental		Device: Transcranial electrical stimulation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transcranial electrical stimulation	Device		Transcranial electrical stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)		9 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Colleen Loo, MBBS	University of New South Wales	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Black Dog Institute / University of New South Wales		Randwick, Sydney	New South Wales	2031	Australia

Condition Browse Module

MeSH Terms

ID	Term
D003865	Depressive Disorder, Major
D001714	Bipolar Disorder
D003863	Depression

Ancestor Terms

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D065908	Transcranial Direct Current Stimulation

Ancestor Terms

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D003295	Convulsive Therapy
D013000	Psychiatric Somatic Therapies

Browse Leaves

Not provided

Browse Branches

Not provided