A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression
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|ClinicalTrials.gov Identifier: NCT00481026|
Recruitment Status : Unknown
Verified May 2007 by Bayside Health.
Recruitment status was: Recruiting
First Posted : June 1, 2007
Last Update Posted : May 9, 2008
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:
- A study using tDCS to treat both the positive and negative symptoms of schizophrenia. The negative symptoms of schizophrenia such as lack of motivation and energy appear to arise due to a lack of activity in frontal brain areas. Positive symptoms such as hallucinations and confused thoughts may arise through over activity of brain areas more on the side and towards the back of the brain called the temporal cortex. We plan to apply tDCS such that it can simultaneously increased activity in these frontal brain areas and reduce activity over temporal cortex. We will compare active stimulation to a placebo condition which involves turning the stimulator off after 30 seconds. The capacity to target multiple symptom clusters is unique with this type of brain stimulation.
- The study using tDCS in treatment resistant depression builds on a work with transcranial magnetic stimulation (TMS). TMS techniques in depression seem to work which increased left frontal brain activity or decrease right frontal brain activity. tDCS will be used to do the same thing with the anode used to increase left-sided brain activity and the cathode used to simultaneously decreased right-sided brain activity.
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 or disease||Intervention/treatment||Phase|
|Schizophrenia Major Depression||Device: transcranial direct current stimulation (tDCS) Device: active tDCS||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression|
|Study Start Date :||July 2007|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||December 2010|
Sham Comparator: Placebo
Device: transcranial direct current stimulation (tDCS)
Active Comparator: active tDCS
Device: active tDCS
- Clinical Scales [ Time Frame: 3 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481026
|Contact: Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP||+61 3 9076 6552 ext email@example.com|
|Contact: Kate E Hoy, BBNSci(Hons)||+61 3 9076 5030 ext firstname.lastname@example.org|
|Alfred Psychiatry Research Centre||Recruiting|
|Prahran, Victoria, Australia, 3181|
|Principal Investigator:||Paul B Fitzgerald, MBBS, MPM, PhD, FRANZCP||Alfred Psychiatry Research Centre|