Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Bayside Health |
---|---|
Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00481026 |
The project will investigate the use of a novel technique, transcranial direct current stimulation (tDCS) in the treatment of patients with schizophrenia and patients with depression. tDCS involves the application of an extremely weak continuous electrical current to the brain through the placement of anode and a cathode on the scalp. The electrical current is generally completely imperceptible after initial period of tingling which takes about 30 seconds. Stimulation under the anode appears to increase brain activity where as stimulation under the cathode has the opposite effect. This research plan involves two clinical trials:
tDCS is potentially a better tolerated procedure than TMS and does not appear to have the same risk of seizure induction. Importantly, the equipment is quite inexpensive and this may prove to be an extremely safe and effective low-cost treatment for psychiatric disorders in Third World countries.
Condition | Intervention |
---|---|
Schizophrenia Major Depression |
Device: transcranial direct current stimulation (tDCS) Device: active tDCS |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression |
Estimated Enrollment: | 100 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Sham Comparator
Placebo tDCS
|
Device: transcranial direct current stimulation (tDCS)
tDCS
|
active tDCS: Active Comparator
active tDCS
|
Device: active tDCS
Active tDCS
|
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Participants will be included if they:
Concomitant medications including:
Participants will be included if they:
Concomitant medications including:
Exclusion Criteria:
Patients will be excluded if they:
Patients will be withdrawn from the study if they:
Contact: Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP | +61 3 9076 6552 ext 66552 | p.fitzgerald@alfred.org.au |
Contact: Kate E Hoy, BBNSci(Hons) | +61 3 9076 5030 ext 65030 | k.hoy@alfred.org.au |
Australia, Victoria | |
Alfred Psychiatry Research Centre | Recruiting |
Prahran, Victoria, Australia, 3181 |
Principal Investigator: | Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP | Alfred Psychiatry Research Centre |
Responsible Party: | Alfred Psychiatry Research Centre ( Professor Paul Fitzgerald ) |
Study ID Numbers: | 11707 |
Study First Received: | May 30, 2007 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00481026 History of Changes |
Health Authority: | Australia: Human Research Ethics Committee |
Schizophrenia Depression Mental Disorders Mood Disorders Psychotic Disorders |
Depressive Disorder, Major Depressive Disorder Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |
Schizophrenia Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Schizophrenia and Disorders with Psychotic Features Behavioral Symptoms |