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/NCT01562184




Registration number
NCT01562184
Ethics application status
Date submitted
21/03/2012
Date registered
23/03/2012
Date last updated
2/12/2015

Titles & IDs
Public title
Investigating tDCS as a Treatment for Unipolar and Bipolar Depression
Scientific title
A Controlled Trial of Transcranial Direct Current Stimulation as a Treatment for Unipolar and Bipolar Depression
Secondary ID [1] 0 0
#11T-005
Secondary ID [2] 0 0
HC11515
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Sham tDCS device
Treatment: Devices - Soterix tDCS device

Active Comparator: Active tDCS - Active tDCS

Sham Comparator: Sham tDCS - Sham tDCS


Treatment: Devices: Sham tDCS device
Sham tDCS

Treatment: Devices: Soterix tDCS device
Active tDCS
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
12 weeks
Secondary outcome [1] 0 0
Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Montreal Cognitive Assessment (MoCA): Global Cognitive Function
Timepoint [2] 0 0
8 weeks

Eligibility
Key inclusion criteria
- 18 years of age or above.

- Meets criteria for a DSM-IV Major Depressive Episode with duration of at least 4
weeks.

- Total score = 20 on the Montgomery-Asberg Depression Rating Scale at study entry.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Current episode duration greater than 3 years.

- Failed more than 3 adequate antidepressant trials in current episode.

- DSM-IV psychotic disorder.

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

- Inadequate response to ECT in the current episode of depression.

- Rapid clinical response required, e.g., high suicide risk.

- Significant acute suicide risk, defined as follows: suicide attempt within the
previous 6 months that required medical treatment; or = 2 suicide attempts in the past
12 months; or has a clear-cut plan for suicide and states that they cannot guarantee
that they will call their regular psychiatrist or the investigator if the impulse to
implement the plan becomes substantial during the study; or in the investigator's
opinion, is likely to attempt suicide within the next 6 months.

- Clinically defined neurological disorder or insult.

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

- Pregnancy.

- Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
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
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
University of New South Wales / Black Dog Institute - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Georgia
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas

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
Duke University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Emory University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sheppard Pratt Health System
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University of Medicine and Dentistry of New Jersey
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Texas
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Transcranial direct current stimulation (tDCS) is a novel treatment approach for depression
that has shown promising efficacy in four recent double-blind, randomized, sham-controlled
trials (RCT) and a meta-analysis. This study is a RCT of tDCS in depressed patients, testing
its efficacy in both unipolar and bipolar depression. Mood, cognitive test performance and
biomarkers will be measured during the trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01562184
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/NCT01562184