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Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Active tDCS + CBT
Sham tDCS + CBT
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. Participants will be ≥ 18 years old.
  2. Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration.
  3. MADRS score ≥ 20 at study entry.

Exclusion Criteria:

  1. Participant is unable to give informed consent.
  2. DSM-IV diagnosis of psychotic disorder (lifetime).
  3. Bipolar disorder diagnosis and not on a mood stabiliser.
  4. Eating disorder (current or within past year).
  5. Obsessive compulsive disorder (lifetime).
  6. Post-traumatic stress disorder (current or within past year).
  7. Mental retardation.
  8. Drug or alcohol abuse or dependence (preceding 3 months).
  9. Inadequate response to ECT (current episode of depression).
  10. Rapid clinical response required, e.g., high suicide risk, inanition or psychosis.
  11. Clinically defined neurological disorder or insult.
  12. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  13. Pregnancy.
  14. Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
  15. Change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial.
  16. Participant becomes hypomanic or manic, as defined by DSM-IV.

Sites / Locations

  • Belmont Private HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Outcomes

Primary Outcome Measures

Montgomery Asberg Depression Rating Scale for Depression (MADRS)

Secondary Outcome Measures

Depression and Anxiety Stress Scale

Full Information

First Posted
October 27, 2013
Last Updated
December 2, 2014
Sponsor
The University of New South Wales
Collaborators
Belmont Private Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01974076
Brief Title
Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)
Official Title
A Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behavioural Therapy (CBT) for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will investigate whether transcranial direct current stimulation (tDCS) can enhance the efficacy of cognitive behavioural therapy for the treatment of depression.

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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Active tDCS + CBT
Intervention Type
Device
Intervention Name(s)
Sham tDCS + CBT
Primary Outcome Measure Information:
Title
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Depression and Anxiety Stress Scale
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be ≥ 18 years old. Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration. MADRS score ≥ 20 at study entry. Exclusion Criteria: Participant is unable to give informed consent. DSM-IV diagnosis of psychotic disorder (lifetime). Bipolar disorder diagnosis and not on a mood stabiliser. Eating disorder (current or within past year). Obsessive compulsive disorder (lifetime). Post-traumatic stress disorder (current or within past year). Mental retardation. Drug or alcohol abuse or dependence (preceding 3 months). Inadequate response to ECT (current episode of depression). Rapid clinical response required, e.g., high suicide risk, inanition or psychosis. 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. Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication. Change in psychotropic medication during 2-week period prior to the study or during the course of the 3-week trial. Participant becomes hypomanic or manic, as defined by DSM-IV.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandy Sacre
Email
sandy.sacre@healthecare.com.au
Facility Information:
Facility Name
Belmont Private Hospital
City
Carina, Brisbane
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandy Sacre
Email
sandy.sacre@healthecare.com.au
First Name & Middle Initial & Last Name & Degree
Sandy Sacre
First Name & Middle Initial & Last Name & Degree
Saibal Guha

12. IPD Sharing Statement

Learn more about this trial

Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)

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