Schizophrenia TreAtment With electRic Transcranial Stimulation (STARTS)

May 10, 2019 updated by: Leandro Valiengo, University of Sao Paulo

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil
        • University of Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active tDCS
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.
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.
Other Names:
  • Transcranial eletric stimulation
Sham Comparator: Sham tDCS
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.
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.
Other Names:
  • Transcranial eletric stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in subscale of PANSS
Time Frame: Repeated measures: 0, 2, 4 and 6 weeks (endpoint)
Reduction of PANSS negative subscale (continuous measure) at 6 weeks
Repeated measures: 0, 2, 4 and 6 weeks (endpoint)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Stanley Medical Research Institute
Instituto Bairral de Psiquiatria

Investigators

  • Principal Investigator: Leandro Valiengo, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

August 26, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

August 28, 2015

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 31063714.1.1001.0068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Transcranial Direct Current Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe