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Trial of Bilateral tDCS for Depression

Primary Purpose

Depression

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Eldith Neuroconn tDCS device
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
  3. Inadequate response to ECT in the current episode of depression.
  4. Participant is on regular benzodiazepine medication which is not clinically appropriate to discontinue.
  5. Participant requires a rapid clinical response due to inanition, psychosis or high suicide risk.
  6. Neurological disorder or insult, e.g., recent stroke (CVA), which places participant at risk of seizure or neuronal damage with tDCS.
  7. Participant has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  8. Female participant who is pregnant, or of child-bearing age, sexually active and not using reliable contraception (urine test for pregnancy will be used).
  9. Participants who are not fluent in English will not be included in the trial for safety reasons.

Sites / Locations

  • Black Dog Institute / University of New South Wales

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active tDCS (1)

Active tDCS (2)

Arm Description

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Secondary Outcome Measures

Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

Full Information

First Posted
May 5, 2013
Last Updated
September 15, 2015
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT01849367
Brief Title
Trial of Bilateral tDCS for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS (1)
Arm Type
Experimental
Arm Title
Active tDCS (2)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Eldith Neuroconn tDCS device
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Black Dog Institute / University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia

12. IPD Sharing Statement

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Trial of Bilateral tDCS for Depression

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