Schizophrenia TreAtment With electRic Transcranial Stimulation

Study Overview
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Brief Summary
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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.

Official Title
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Treatment of Negative Symptoms of Schizophrenia With Transcranial Direct Current Stimulation (tDCS): A Randomized, Double-blinded, Sham-controlled, Clinical Trial

Conditions
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Schizophrenia

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS<br>Sham Comparator: Sham Stimulation In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the temporo-parietal cortex with the Transcranial Direct Current Stimulation. The device will deliver a charge of 2mA for 20 minutes. | Device: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: Transcranial eletric stimulation;|
| Sham Comparator: Sham tDCS<br>Sham Comparator: Sham Stimulation In active stimulation, the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the temporo-parietal cortex with the Transcranial Direct Current Stimulation. The device will deliver a charge of 2mA for 1 minute, after that the device will be automatically turned off for 19 minutes. | Device: Transcranial Direct Current Stimulation<br>* 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.<br>* Other names: Transcranial eletric stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in subscale of PANSS | Reduction of PANSS negative subscale (continuous measure) at 6 weeks | Repeated measures: 0, 2, 4 and 6 weeks (endpoint) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in SANS | Reduction of SANS (continuous measure) | Repeated measures: 0, 2, 4, 6 and 12 weeks | 
| Change in Negative subscale of PANSS | Reduction of PANSS negative subscale (continuous measure) | 12 weeks | 
| Change in Auditory Verbal Hallucination Scale | Continuous measure | Repeated measures: 0, 2, 4, 6 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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schizophrenia, transcranial stimulation