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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01201148




Registration number
NCT01201148
Ethics application status
Date submitted
8/09/2010
Date registered
14/09/2010
Date last updated
2/12/2015

Titles & IDs
Public title
Open Pilot Trial of TES for Depression
Scientific title
A Study of Transcranial Electrical Stimulation (TES) for the Treatment of Depression
Secondary ID [1] 0 0
10231
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 - tDCS (Eldith DC-Stimulator (CE certified))

Experimental: Oscillating or intermittent tDCS -


Treatment: Devices: tDCS (Eldith DC-Stimulator (CE certified))
For participants receiving intermittent tDCS or oscillating TES, one electrode will be placed over the left pF3 electrode site (overlying the left dorsolateral prefrontal cortex and identified on the scalp using an EEG cap based on the 10/20 system) and the other over the right temporal area.
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
6 months

Eligibility
Key inclusion criteria
* Subject meets criteria for a DSM-IV Major Depressive episode.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis (as defined by DSM-IV) of: any psychotic disorder (lifetime); bipolar disorder; eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year); mental retardation.
* Subject has not responded adequately to standard tDCS or is not appropriate for trial of standard tDCS (eg depression too chronic in duration)
* Total MADRS depression score of 20 or more
* History of drug or alcohol abuse or dependence (as per DSM-IV criteria) within the last 3 months (except nicotine and caffeine).
* Inadequate response to ECT in the current episode of depression.
* Subject is on regular benzodiazepine medication which it is not clinically appropriate to discontinue.
* Subject requires a rapid clinical response due to inanition, psychosis or high suicide risk.
* Neurological disorder or insult, e.g., recent stroke (CVA), which places subject at risk of seizure or neuronal damage with TES.
* Subject has metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Female subject who is pregnant. However, women of child bearing age are eligible if they have the pregnancy test but will be excluded if they are sexually active and not using reliable contraception (urine test for pregnancy will be used if appropriate).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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 2
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
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute - 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 will investigate whether using oscillating TES (random noise stimulation) or intermittent tDCS will have greater antidepressant effects in depressed subjects, compared to standard tDCS.
Trial website
https://clinicaltrials.gov/study/NCT01201148
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo, MBBS
Address 0 0
School of Psychiatry, University of New South Wales
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/study/NCT01201148