Schizophrenia TreAtment With electRic Transcranial Stimulation

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT02535676
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-08-26
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-28
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-10
• Last Update Posted: 2019-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Transcranial Direct Current Stimulation	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.
Sham tDCS	Transcranial Direct Current Stimulation	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change in SANS	Repeated measures: 0, 2, 4, 6 and 12 weeks	Reduction of SANS (continuous measure)

Trial Locations

Locations (1)

University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil