Schizophrenia TreAtment With electRic Transcranial Stimulation

University of Sao Paulo100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Schizophrenia

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in subscale of PANSS

Reduction of PANSS negative subscale (continuous measure) at 6 weeks

Time frame: Repeated measures: 0, 2, 4 and 6 weeks (endpoint)

Secondary Outcomes

Change in SANS

Reduction of SANS (continuous measure)

Time frame: Repeated measures: 0, 2, 4, 6 and 12 weeks

Change in Negative subscale of PANSS

Reduction of PANSS negative subscale (continuous measure)

Time frame: 12 weeks

Change in Auditory Verbal Hallucination Scale

Continuous measure