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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

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.

Condition or disease Intervention/treatment Phase
Depression Other: Transcranial direct current stimulation combined with cognitive training Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression.
Study Start Date : November 2014
Estimated Primary Completion Date : November 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: tDCS + CT Other: Transcranial direct current stimulation combined with cognitive training



Primary Outcome Measures :
  1. Montgomery and Asberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296437


Contacts
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Contact: Donel Martin, PhD 61 2 9382 8353 donel.martin@unsw.edu.au

Locations
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Australia, New South Wales
University of New South Wales Recruiting
Sydney, New South Wales, Australia, 2031
Contact: Donel Martin, PhD    61 2 9382 8353    donel.martin@unsw.edu.au   
Sponsors and Collaborators
The University of New South Wales
Icahn School of Medicine at Mount Sinai

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Responsible Party: Melissa Pigot, Research assistant, The University of New South Wales
ClinicalTrials.gov Identifier: NCT02296437     History of Changes
Other Study ID Numbers: HC14216
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders