Transcranial Electrical Stimulation (TES) for the Treatme... | NCT01792414

Studies
Transcranial Electrical Stimulation (TES) for the Treatment of Depression.

NCT01792414

Sponsor

The University of New South Wales

Status

Completed

Last Update Posted

Feb 2, 2017Estimated

Enrollment

70Actual

Phase

Not Applicable

Conditions

Major Depression

Interventions

Sham TES
Active TES

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

Feb 2017

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

Jan 2013

Primary Completion Date

Dec 2016Actual

Completion Date

Dec 2016Actual

First Submitted Date

Feb 13, 2013

First Submission Date that Met QC Criteria

Feb 13, 2013

First Posted Date

Feb 15, 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

Feb 1, 2017

Last Update Posted Date

Feb 2, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a RCT of transcranial electrical stimulation in depressed patients. Mood, cognitive test performance and biomarkers will be measured during the trial.

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

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active TES	Active Comparator	Active TES	Device: Active TES
Sham TES	Sham Comparator	Sham TES	Device: Sham TES

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sham TES	Device	Neuroconn Eldith device	Sham TES
Active TES

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)		12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Beck Depression Inventory II		12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.
MADRS score ≥ 20 at study entry.

Exclusion Criteria:

DSM-IV psychotic disorder;
drug or alcohol abuse or dependence (preceding 12 months);
inadequate response to ECT (current episode of depression);
anticonvulsant or benzodiazepine medication;
rapid clinical response required, e.g. high suicide risk; 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.

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

Not provided

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31899509	Derived	Nikolin S, Alonzo A, Martin D, Galvez V, Buten S, Taylor R, Goldstein J, Oxley C, Hadzi-Pavlovic D, Loo CK. Transcranial Random Noise Stimulation for the Acute Treatment of Depression: A Randomized Controlled Trial. Int J Neuropsychopharmacol. 2020 Apr 21;23(3):146-156. doi: 10.1093/ijnp/pyz072.

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders