Schizophrenia TreAtment With electRic Transcranial Stimulation

Schizophrenia Clinical Trial

— STARTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535676
• Other study ID #: 31063714.1.1001.0068
• Status: Completed
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: May 2018

Study information

• Verified date: May 2019
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Instituto Bairral de Psiquiatria, Stanley Medical Research Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in SANS	Reduction of SANS (continuous measure)	Repeated measures: 0, 2, 4, 6 and 12 weeks
Secondary	Change in Negative subscale of PANSS	Reduction of PANSS negative subscale (continuous measure)	12 weeks
Secondary	Change in Auditory Verbal Hallucination Scale	Continuous measure	Repeated measures: 0, 2, 4, 6 and 12 weeks