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Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia

Schizophrenia Clinical Trial

Official title:
Transcranial Direct Current Stimulation (tDCS) as Therapeutical Strategy for Negative Symptoms in Schizophrenia: a Double-blind Randomized Clinical Trial

Clinical Trial Summary

The current research is aimed at using Transcranial Direct Current Stimulation (tDCS) as complementary therapeutic tool in the treatment of schizophrenia. Patients will be randomized into two groups (tDCS-active x tDCS-sham) accordingly to detailed protocol. Main outcome will be measured by specific clinical rating scales based on the assessment of negative symptoms. A total of 40 patients ought to be enrolled as specified in methodology. Secondary outcomes shall include collateral effects evaluation, anxiety and depressive scales as well as clinical monitoring.

Clinical Trial Description

Overview

The present study is a double-blind randomized clinical trial in which patients should be allocated from a General Psychiatry Service into two groups (tDCS-active x tDCS-sham). Subjects who fulfilled eligibility criteria will undergo ten days of consecutive stimulation (active or sham) and will return after two to four weeks for final clinical assessment. Patients who shown no response in rating scales and that were allocated to sham intervention group will be able to choose whether or not they want to undergo the active intervention at follow up (partial cross-over) ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01623726
Study type Interventional
Source University of Sao Paulo
Contact
Status Withdrawn
Phase Phase 2
Start date August 2012
Completion date August 2014
View Details
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