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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01974076




Registration number
NCT01974076
Ethics application status
Date submitted
27/10/2013
Date registered
1/11/2013
Date last updated
4/12/2014

Titles & IDs
Public title
Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behaviour Therapy (CBT)
Scientific title
A Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunct to Cognitive Behavioural Therapy (CBT) for Depression
Secondary ID [1] 0 0
HC13276
Universal Trial Number (UTN)
Trial acronym
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
Treatment: Devices - Active tDCS + CBT
Treatment: Devices - Sham tDCS + CBT

Active Comparator: Active tDCS -

Sham Comparator: Sham tDCS -


Treatment: Devices: Active tDCS + CBT


Treatment: Devices: Sham tDCS + CBT
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Montgomery Asberg Depression Rating Scale for Depression (MADRS)
Timepoint [1] 0 0
3 weeks
Secondary outcome [1] 0 0
Depression and Anxiety Stress Scale
Timepoint [1] 0 0
3 weeks

Eligibility
Key inclusion criteria
1. Participants will be = 18 years old.

2. Have a DSM-IV diagnosis of Major Depressive Episode of minimum 4 weeks duration.

3. MADRS score = 20 at study entry.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant is unable to give informed consent.

2. DSM-IV diagnosis of psychotic disorder (lifetime).

3. Bipolar disorder diagnosis and not on a mood stabiliser.

4. Eating disorder (current or within past year).

5. Obsessive compulsive disorder (lifetime).

6. Post-traumatic stress disorder (current or within past year).

7. Mental retardation.

8. Drug or alcohol abuse or dependence (preceding 3 months).

9. Inadequate response to ECT (current episode of depression).

10. Rapid clinical response required, e.g., high suicide risk, inanition or psychosis.

11. Clinically defined neurological disorder or insult.

12. Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash)
at proposed electrode sites.

13. Pregnancy.

14. Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.

15. Change in psychotropic medication during 2-week period prior to the study or during
the course of the 3-week trial.

16. Participant becomes hypomanic or manic, as defined by DSM-IV.

Study design
Purpose of the study
Treatment
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


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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
1/05/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
135
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Belmont Private Hospital - Carina, Brisbane
Recruitment postcode(s) [1] 0 0
4152 - Carina, Brisbane

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
Belmont Private Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will investigate whether transcranial direct current stimulation (tDCS) can
enhance the efficacy of cognitive behavioural therapy for the treatment of depression.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01974076
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
Sandy Sacre
Address 0 0
Country 0 0
Phone 0 0
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/NCT01974076