Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01339598




Registration number
NCT01339598
Ethics application status
Date submitted
7/04/2011
Date registered
20/04/2011
Date last updated
3/11/2015

Titles & IDs
Public title
Remediation of Cognitive Dysfunction in Euthymic Bipolar Disorder Patients Using Transcranial Direct Current Stimulation (tDCS)
Scientific title
Secondary ID [1] 0 0
HREC 11065
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Transcranial direct current stimulation (Eldith DC Stimulator)

Sham Comparator: Sham transcranial direct current stimulation -

Active Comparator: Transcranial direct current stimulation -

Active Comparator: Different transcranial direct current stimulation montage -


Treatment: Devices: Transcranial direct current stimulation (Eldith DC Stimulator)
Eldith DC Stimulator (NeuroConn GmbH, Germany)
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Total correct responses.
Timepoint [1] 0 0
Across each session (approximately 1 hour in duration), with each session conducted at least 1 week apart.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New South Wales - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01339598
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01339598