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Completed

NCT Number: NCT01339598

Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)

This study aims to investigate the potential for Transcranial Direct Current Stimulation (tDCS) to enhance cognitive functioning in euthymic bipolar patients through comparing the effect of active or sham tDCS (placebo control) during the performance of two cognitive tasks. The investigators hypothesize that task performance will be improved with active relative to sham tDCS.

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Key information

Conditions

Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of New South Wales

Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants will be right-handed subjects aged 18-65 meeting DSM-IV diagnostic criteria for bipolar disorder, with no acute episodes of depression or mania within the previous 12 weeks
  • A score of ≤ 20 on the MADRS, and a score of ≤ 6 on the YMRS, who have been on a stable dose of mood stabiliser medications for at least 1 month.

Exclusion criteria

  • Patients with high suicide risk
  • Co-morbid DSM-IV diagnosis of any psychotic disorder (current or within the last year), schizophrenia and schizoaffective disorder
  • Mental retardation
  • A history of drug or alcohol abuse or dependence within the last 3 months
  • Co-morbid attention deficit hyperactivity disorder (ADHD), or any neurological disorder
  • Recent stroke
  • Head injury
  • History of seizure, or who have had electroconvulsive therapy (ECT) within the 6 months preceding enrolment.
  • Participants will also be excluded if currently taking medications known to be associated with frank cognitive impairment (e.g., benzodiazepines).

Treatment and study plan

Transcranial direct current stimulation (Eldith DC Stimulator)

Device

Eldith DC Stimulator (NeuroConn GmbH, Germany)

Primary outcomes

  1. Total correct responses.

    Time frame: Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.

    Total number of correct responses on each task in each session.

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Apr 20, 2011
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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