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/NCT02296437




Registration number
NCT02296437
Ethics application status
Date submitted
18/11/2014
Date registered
20/11/2014
Date last updated
17/10/2017

Titles & IDs
Public title
Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression
Scientific title
Pilot Study of Transcranial Direct Current Stimulation (tDCS) and Cognitive Task in Depression.
Secondary ID [1] 0 0
HC14216
Universal Trial Number (UTN)
Trial acronym
tDCS + CT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Transcranial direct current stimulation combined with cognitive training

Experimental: tDCS + CT -


Other interventions: Transcranial direct current stimulation combined with cognitive training
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery and Asberg Depression Rating Scale (MADRS)
Timepoint [1] 0 0
6 weeks

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

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
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
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Icahn School of Medicine at Mount Sinai
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02296437
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
Donel Martin, PhD
Address 0 0
Country 0 0
Phone 0 0
61 2 9382 8353
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02296437