Trial of Bilateral tDCS for Depression | NCT01849367

Studies
Trial of Bilateral tDCS for Depression

NCT01849367

Sponsor

The University of New South Wales

Status

Completed

Last Update Posted

Sep 17, 2015Estimated

Enrollment

4Actual

Phase

Phase 1Phase 2

Conditions

Depression

Interventions

Eldith Neuroconn tDCS device

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

Sep 2015

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

May 2013

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

May 5, 2013

First Submission Date that Met QC Criteria

May 7, 2013

First Posted Date

May 8, 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

Sep 15, 2015

Last Update Posted Date

Sep 17, 2015Estimated

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

Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression that has shown promising efficacy in four recent double-blind, randomized, sham-controlled trials (RCT) and a meta-analysis. 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

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Label	Type	Description	Intervention Names
Active tDCS (1)	Experimental		Device: Eldith Neuroconn tDCS device
Active tDCS (2)	Active Comparator		Device: Eldith Neuroconn tDCS device

Name	Type	Description	Arm Group Labels	Other Names
Eldith Neuroconn tDCS device	Device		Active tDCS (1) Active tDCS (2)

Measure	Description	Time Frame
Montgomery Asberg Depression Rating Scale for Depression (MADRS)		4 weeks

Measure	Description	Time Frame
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant meets criteria for a DSM-IV Major Depressive episode.
MADRS score of 20 or more.

Exclusion Criteria:

Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
Inadequate response to ECT in the current episode of depression.
Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.
Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.
Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
Participants who are not fluent in English will not be included in the trial for safety reasons.

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

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior