- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01346306
Trial of Transcranial Direct Current Stimulation (tDCS)
March 28, 2023 updated by: Colleen Loo, The University of New South Wales
Investigating Direct Current Stimulation as a Treatment for Depression: A Controlled Clinical Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subject meets criteria for a DSM-IV Major Depressive Episode.
- Total MADRS score ≥20.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: DCS 1
|
Direct current stimulation montage 1.
Other Names:
Direct current stimulation montage 2.
Other Names:
|
Experimental: DCS 2
|
Direct current stimulation montage 1.
Other Names:
Direct current stimulation montage 2.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Montgomery Asberg Depression Rating Scale for Depression (MADRS).
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2011
Primary Completion (Actual)
December 23, 2019
Study Completion (Actual)
December 23, 2019
Study Registration Dates
First Submitted
April 13, 2011
First Submitted That Met QC Criteria
April 29, 2011
First Posted (Estimate)
May 2, 2011
Study Record Updates
Last Update Posted (Actual)
March 30, 2023
Last Update Submitted That Met QC Criteria
March 28, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HC16360
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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