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Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression (tDCS + CT)

Primary Purpose

Depression

Status
Unknown status
Phase
Early Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Transcranial direct current stimulation combined with cognitive training
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 - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants are aged 18-65 years.
  2. Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan.
  3. MADRS score of 20 or more.
  4. Right handed
  5. A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment.

Exclusion Criteria:

  1. DSM-V psychotic disorder.
  2. Drug or alcohol abuse or dependence (preceding 6 months).
  3. Inadequate response to ECT (current episode of depression).
  4. Regular benzodiazepine medication
  5. Rapid clinical response required, e.g., due to high suicide risk.
  6. Clinically defined neurological disorder or insult.
  7. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
  8. Pregnancy.

Sites / Locations

  • University of New South WalesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tDCS + CT

Arm Description

Outcomes

Primary Outcome Measures

Montgomery and Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Full Information

First Posted
November 18, 2014
Last Updated
October 15, 2017
Sponsor
The University of New South Wales
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT02296437
Brief Title
Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression
Acronym
tDCS + CT
Official Title
Pilot Study of Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2019 (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
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Among antidepressant treatments, electroconvulsive therapy (ECT) remains the most effective. However, patient concerns with cognitive side effects have encouraged trials of new, non-convulsive forms of mild brain stimulation such as transcranial Direct Current Stimulation (tDCS). Our past and present studies of tDCS suggest that it has antidepressant effects and is safe, painless and well tolerated. However, not all patients may have an adequate response, raising the need to find ways of optimising efficacy. This clinical pilot study will examine the feasibility and safety of combining tDCS with a cognitive training task which engages the same brain region targeted by tDCS for 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
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS + CT
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Transcranial direct current stimulation combined with cognitive training
Primary Outcome Measure Information:
Title
Montgomery and Asberg Depression Rating Scale (MADRS)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants are aged 18-65 years. Participant meets criteria for a DSM-V Major Depressive episode. Criteria are as follows: Five or more symptoms present during the same 2-week period, including either 1 or 2: 1) depressed mood, 2) loss of interest or pleasure, 3) significant weight loss or gain, 4) insomnia or hypersomnia, 5) psychomotor agitation or retardation, 6) fatigue or loss of energy, 7) feelings of worthlessness or excessive or inappropriate guilt, 8) diminished ability to think concentrate or make decisions, and 9) recurrent thoughts of death, recurrent suicidal ideation, suicide attempt or plan. MADRS score of 20 or more. Right handed A history of non-response to ≥ 2 adequate trials of antidepressant medication treatment. Exclusion Criteria: DSM-V psychotic disorder. Drug or alcohol abuse or dependence (preceding 6 months). Inadequate response to ECT (current episode of depression). Regular benzodiazepine medication Rapid clinical response required, e.g., due to 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Donel Martin, PhD
Phone
61 2 9382 8353
Email
donel.martin@unsw.edu.au
Facility Information:
Facility Name
University of New South Wales
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donel Martin, PhD
Phone
61 2 9382 8353
Email
donel.martin@unsw.edu.au

12. IPD Sharing Statement

Learn more about this trial

Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression

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