Trial of Transcranial Direct Current Stimulation (tDCS)
This study is currently recruiting participants.
Verified February 2013 by The University of New South Wales
Sponsor:
The University of New South Wales
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01346306
First received: April 13, 2011
Last updated: February 3, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depression |
Device: Eldith Company - direct current stimulator |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Investigating Direct Current Stimulation as a Treatment for Depression: A Controlled Clinical Trial |
Resource links provided by NLM:
Further study details as provided by The University of New South Wales:
Primary Outcome Measures:
- Montgomery Asberg Depression Rating Scale for Depression (MADRS). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2011 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: DCS 1 |
Device: Eldith Company - direct current stimulator
Direct current stimulation montage 1.
Other Name: Neuroconn - direct current stimulator
|
| Experimental: DCS 2 |
Device: Eldith Company - direct current stimulator
Direct current stimulation montage 2.
Other Name: Neuroconn - direct current stimulator
|
| Sham Comparator: Sham DCS |
Device: Eldith Company - direct current stimulator
Sham direct current stimulation.
Other Name: Neuroconn - direct current stimulator
|
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346306
Contacts
| Contact: Angelo Alonzo, PhD | 61-2-93823720 | a.alonzo@unsw.edu.au |
| Contact: Donel Martin, PhD | 61-2-93829261 | donel.martin@unsw.edu.au |
Locations
| Australia, New South Wales | |
| Black Dog Institute | Recruiting |
| Randwick, Sydney, New South Wales, Australia, 2031 | |
| Principal Investigator: Colleen Loo, MBBS, FRANZCP, MD | |
Sponsors and Collaborators
The University of New South Wales
Investigators
| Principal Investigator: | Colleen Loo, MBBS, FRANZCP, MD | School of Psychiatry, University of New South Wales |
More Information
No publications provided
| Responsible Party: | Colleen Loo, Professor, The University of New South Wales |
| ClinicalTrials.gov Identifier: | NCT01346306 History of Changes |
| Other Study ID Numbers: | 11036 |
| Study First Received: | April 13, 2011 |
| Last Updated: | February 3, 2013 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration Australia: Human Research Ethics Committee |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013