A Study of Transcranial Direct Current Stimulation (tDCS) to Treat Depression
This study has been completed.
Sponsor:
The University of New South Wales
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00763230
First received: September 26, 2008
Last updated: April 29, 2011
Last verified: March 2011
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Purpose
Depression is a common illness with an approximate lifetime prevalence of 17 %, conferring a large burden of disease in the community, often due to inadequate treatment. Thus there is interest in the therapeutic potential of non invasive, novel forms of brain stimulation, such as transcranial direct current stimulation (tDCS). Two small studies have been published in the last two years indicating that 20 minutes of either 1 or 2mA tDCS over 5 or 10 sessions is safe, painless and well tolerated. The investigators' own pilot data (N=30) also suggests the technique has antidepressant effects and is safe (5-10 sessions of tDCS at 1 mA).
This study will extend previous findings, testing a more definitive tDCS approach (also left prefrontal anodal stimulation) with a longer treatment course (15 sessions), at 2 mA (which has been found to be safe and more effective than 1 mA in cognitive studies), and in a larger sample (N=68), using a placebo-controlled design.
It is hypothesised that active tDCS (15 sessions) will have greater efficacy than sham treatment (15 sessions) in reducing the severity of depressive symptoms in patients in an episode of major depression. A second hypothesis is that 15 sessions of tDCS will not cause any significant adverse effects or cause decline in neuropsychological functioning in comparison to a sham control.
| Condition | Intervention | Phase |
|---|---|---|
|
Depressive Disorder, Major Bipolar Disorder |
Device: Transcranial direct current stimulation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Sham-controlled Study of Transcranial Direct Current Stimulation (tDCS) as a Treatment for Depression |
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: 6 months ] [ Designated as safety issue: No ]Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment
Secondary Outcome Measures:
- Inventory of Depressive Symptomatology (IDS-C) [ Time Frame: 6 months ] [ Designated as safety issue: No ]Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment
- Quick Inventory of Depressive Symptomatology - Self rated (QIDS-SR) [ Time Frame: Baseline (pre-treatment), post 8, 15, 23 and 30 tDCS sessions, and follow-up 1 week, 1 month, 3 months and 6 months post treatment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 68 |
| Study Start Date: | April 2008 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: active
Full active tDCS treatment
|
Device: Transcranial direct current stimulation
tDCS will be given every weekday. For each session, tDCS will be given continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash as described in the safety section above). For sham stimulation, the current will be left on for another 30s, then gradually reduced to zero over another 30 seconds, so that the initial tingling sensation experienced by subjects will be identical for the two groups. The stimulator will be placed behind the subject's head so any adjustments to the current by the operator are not evident. This sham procedure resulted in successful blinding in our pilot study.
Other Name: Eldith DC-Stimulator (CE certified)
|
|
Sham Comparator: sham
Placebo tDCS will be give
|
Device: Transcranial direct current stimulation
tDCS will be given every weekday. For each session, tDCS will be given continuously for 20 minutes at 2 mA. Conductive rubber electrodes (7 x 5 cm, 35 cm2) covered by sponges soaked in saline will be used, held in place by a head band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash as described in the safety section above). For sham stimulation, the current will be left on for another 30s, then gradually reduced to zero over another 30 seconds, so that the initial tingling sensation experienced by subjects will be identical for the two groups. The stimulator will be placed behind the subject's head so any adjustments to the current by the operator are not evident. This sham procedure resulted in successful blinding in our pilot study.
Other Name: Eldith DC-Stimulator (CE certified)
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meets criteria for DSM-IV Major Depressive Episode
Exclusion Criteria:
- Diagnosis (as defined by DSM-IV) of: any psychotic disorder except bipolar 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, eg 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, or of child-bearing age, sexually active and not using reliable contraception
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763230
Locations
| Australia, New South Wales | |
| Black Dog Institute, University of New South Wales | |
| Randwick, New South Wales, Australia, 2031 | |
Sponsors and Collaborators
The University of New South Wales
Investigators
| Principal Investigator: | Colleen Loo | University of New South Wales |
More Information
Additional Information:
No publications provided by The University of New South Wales
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Associate Professor Colleen Loo, University of New South Wales |
| ClinicalTrials.gov Identifier: | NCT00763230 History of Changes |
| Other Study ID Numbers: | 07305, NHMRC (Australia) |
| Study First Received: | September 26, 2008 |
| Last Updated: | April 29, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by The University of New South Wales:
|
Depression Treatment Transcranial direct current stimulation |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Depressive Disorder, Major |
Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013