Trial Review

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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/NCT01346306




Registration number
NCT01346306
Ethics application status
Date submitted
13/04/2011
Date registered
2/05/2011
Date last updated
30/03/2023

Titles & IDs
Public title
Trial of Transcranial Direct Current Stimulation (tDCS)
Scientific title
Investigating Direct Current Stimulation as a Treatment for Depression: A Controlled Clinical Trial
Secondary ID [1] 0 0
HC16360
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 - Eldith Company - direct current stimulator
Treatment: Devices - Eldith Company - direct current stimulator

Experimental: DCS 1 -

Experimental: DCS 2 -


Treatment: Devices: Eldith Company - direct current stimulator
Direct current stimulation montage 1.

Treatment: Devices: Eldith Company - direct current stimulator
Direct current stimulation montage 2.
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
4 weeks

Eligibility
Key inclusion criteria
- Subject meets criteria for a DSM-IV Major Depressive Episode.

- Total MADRS score =20.
Minimum age
18 Years
Maximum age
90 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); eating
disorder (current or within the past year); obsessive compulsive disorder (lifetime);
post-traumatic stress disorder (current or within the past year); mental retardation.

- 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 tDCS.

- 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.

- Participants who are not fluent in English will not be included in the trial for
safety reasons: a) It is usually not possible to have an interpreter reliably
available every weekday for up to 4 weeks and it is not safe to give tDCS to a subject
who cannot tell us immediately of any side effects; b) As this is a novel treatment,
the study involves detailed neuropsychological testing for safety reasons. This
testing cannot be effectively or validly completed by someone who is not fluent in
English. Note that translation of the proposed tests into English has not been
validated and that we cannot be confident that neuropsychological impairment would be
detected using this method.

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
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
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/12/2019
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Black Dog Institute - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

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
Singapore General Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Among antidepressant treatments, ECT stands as the most effective in treating acute
depression. However, patient concerns with the cognitive side effects of ECT have encouraged
the development of new and more focal forms of brain stimulation such as transcranial Direct
Current Stimulation (tDCS). However, not all patients may respond to this treatment in the
way that it is currently administered and this has raised interest in finding alternative,
possibly more optimal ways of administering tDCS. This study will investigate whether tDCS
stimulation using an alternative electrode montage has antidepressant effects. Further
sessions of tDCS, spaced less frequently, will be trialed for maintenance treatment. Mood,
cognitive test performance and biomarkers will be measured periodically in the duration of
the trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01346306
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo, MBBS, FRANZCP, MD
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/ct2/show/NCT01346306