Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

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/NCT01792414




Registration number
NCT01792414
Ethics application status
Date submitted
13/02/2013
Date registered
15/02/2013
Date last updated
2/02/2017

Titles & IDs
Public title
Transcranial Electrical Stimulation (TES) for the Treatment of Depression.
Scientific title
Secondary ID [1] 0 0
HC12143
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major 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 - Sham TES
Treatment: Devices - Active TES

Active Comparator: Active TES - Active TES

Sham Comparator: Sham TES - Sham TES


Treatment: Devices: Sham TES
Neuroconn Eldith device

Treatment: Devices: Active TES
Neuroconn Eldith device
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
Beck Depression Inventory II
Timepoint [1] 0 0
12 weeks

Eligibility
Key inclusion criteria
- DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar
Disorder), of minimum 4 weeks duration.

- 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
- DSM-IV psychotic disorder;

- drug or alcohol abuse or dependence (preceding 12 months);

- inadequate response to ECT (current episode of depression);

- anticonvulsant or benzodiazepine medication;

- rapid clinical response required, e.g. high suicide risk; 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.

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 assessing the outcomes
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2016
Sample size
Target
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute / 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 is a RCT of transcranial electrical stimulation in depressed patients. Mood,
cognitive test performance and biomarkers will be measured during the trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01792414
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/NCT01792414