A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Schizophrenia Major Depression |
Device: transcranial direct current stimulation (tDCS) Device: active tDCS |
| 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 Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression |
- Clinical Scales [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Sham Comparator: Placebo
Placebo tDCS
|
Device: transcranial direct current stimulation (tDCS)
tDCS
|
|
Active Comparator: active tDCS
active tDCS
|
Device: active tDCS
Active tDCS
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Schizophrenia
Participants will be included if they:
- Are voluntary and competent to consent;
- Have a diagnosis of Schizophrenia or Schizoaffective Disorder as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV)
- Have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and
- are between the ages of 18 and 65.
Concomitant medications including:
- Benzodiazepines,
- Mood stabilizers (lithium, valproic acid)
- Antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.
- Depression
Participants will be included if they:
- Are competent to consent;
- Have a diagnosis of Major Depression and are currently experiencing a Major Depressive Episode as confirmed by the Structure Clinical Interview for the DSM-IV (SCID-IV);
- Are treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, an antidepressant trial of sufficient dose for at least 6 weeks; and
- Are between the ages of 18 and 75.
Concomitant medications including:
- Benzodiazepines,
- Mood stabilizers (lithium, valproic acid)
- Antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. Since carbamazepine has been shown to interfere with the effects of anodal tDCS, potential participants taking it will not be suitable for inclusion in the trial.
Exclusion Criteria:
Patients will be excluded if they:
- Have a DSM-IV history of substance abuse or dependence in the last 6 months;
- Have a concomitant major and unstable medical or neurologic illness;
- Are currently taking carbamazepine; or,
- Are pregnant.
Patients will be withdrawn from the study if they:
- Withdraw consent;
- Experience significant clinical deterioration;
- Fail to tolerate the procedure; or,
- Develop a serious adverse event. In the event that a patient is withdrawn or drops out of the study, efforts will be made to obtain a final set of clinical, cognitive and neurophysiological measures at the time of withdrawal for a last observation carried forward analysis.
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Professor Paul Fitzgerald, Alfred Psychiatry Research Centre |
| ClinicalTrials.gov Identifier: | NCT00481026 History of Changes |
| Other Study ID Numbers: | 11707 |
| Study First Received: | May 30, 2007 |
| Last Updated: | May 5, 2008 |
| Health Authority: | Australia: Human Research Ethics Committee |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Schizophrenia Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 19, 2013