Schizophrenia
Conditions
Keywords
schizophrenia, transcranial stimulation
Brief summary
The aim of this study is to evaluate the therapeutic efficacy of tDCS (transcranial direct current stimulation) for treatment of negative symptoms in patients with schizophrenia. The proposed design is a clinical trial, randomized, double-blind, placebo-controlled study. Participants will receive ten sessions of active or sham stimulation in five consecutive days. 100 patients will be randomized into two groups (active tDCS vs sham tDCS) and will be assessed after the intervention: 2, 4, 6 and 12 weeks after. As objectives, the investigators expect to see a clinical improvement of negative symptoms through scales PANSS (Positive and Negative Syndrome Scale), Calgary, Auditory verbal hallucinations, SANS (Skills for Assessment of Negative Symptoms), and expect improvement on computerized cognitive tests. Another goal is to see improvement in biological markers related to schizophrenia, plasma and DNA will be stored.
Interventions
DEVICETranscranial Direct Current Stimulation
The device will produce a direct current of 2 mA from one electrode to the other. In active stimulation, the device will be turned on for 20 min and in sham stimulation the device will be turned in 2 mA for one minute and will be automatically turned off the remaining 19 minutes. The sham or active mode is chosen by a numeric code.
Sponsors
Instituto Bairral de Psiquiatria
Stanley Medical Research Institute
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia according to DSM-IV criteria and confirmed by the SCID * Minimum score of 20 points in the sum of negative PANSS * Stable antipsychotic medications
Exclusion criteria
* Unstable medical illness * Uncontrolled pretreatment with rTMS or tDCS * At least six months without being in ECT * Benzodiazepines in doses of 10mg of diazepam * Electronic or metal implants in the cephalic segment. * Other mental disorders and dependence of substances
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in subscale of PANSS | Repeated measures: 0, 2, 4 and 6 weeks (endpoint) | Reduction of PANSS negative subscale (continuous measure) at 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in SANS | Repeated measures: 0, 2, 4, 6 and 12 weeks | Reduction of SANS (continuous measure) |
| Change in Negative subscale of PANSS | 12 weeks | Reduction of PANSS negative subscale (continuous measure) |
| Change in Auditory Verbal Hallucination Scale | Repeated measures: 0, 2, 4, 6 and 12 weeks | Continuous measure |
Countries
Brazil
Outcome results
None listed