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

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ClinicalTrials.gov Identifier: NCT02296437
Recruitment Status : Unknown
Verified October 2017 by Melissa Pigot, The University of New South Wales.
Recruitment status was:  Recruiting
First Posted : November 20, 2014
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Melissa Pigot, The University of New South Wales

Tracking Information
First Submitted Date  ICMJE November 18, 2014
First Posted Date  ICMJE November 20, 2014
Last Update Posted Date October 17, 2017
Study Start Date  ICMJE November 2014
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 18, 2014)
Montgomery and Asberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02296437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression
Official Title  ICMJE Pilot Study of Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE Other: Transcranial direct current stimulation combined with cognitive training
Study Arms  ICMJE Experimental: tDCS + CT
Intervention: Other: Transcranial direct current stimulation combined with cognitive training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 15, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2014)
20
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02296437
Other Study ID Numbers  ICMJE HC14216
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa Pigot, The University of New South Wales
Study Sponsor  ICMJE The University of New South Wales
Collaborators  ICMJE Icahn School of Medicine at Mount Sinai
Investigators  ICMJE Not Provided
PRS Account The University of New South Wales
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP