NCT02535676

Schizophrenia TreAtment With electRic Transcranial Stimulation

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	Transcranial 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.

Timeline

• Start date: 2014-11-01
• Primary completion: 2018-05-01
• Completion: 2018-05-01
• First posted: 2015-08-28
• Last updated: 2019-05-14

Locations

1 site across 1 country: Brazil