Skip to main content
OpenTrials
Completed

NCT Number: NCT02535676

Schizophrenia TreAtment With electRic Transcranial Stimulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Sao Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Direct Current Stimulation

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in SANS

    Time frame: Repeated measures: 0, 2, 4, 6 and 12 weeks

    Reduction of SANS (continuous measure)

  2. Change in Negative subscale of PANSS

    Time frame: 12 weeks

    Reduction of PANSS negative subscale (continuous measure)

  3. Change in Auditory Verbal Hallucination Scale

    Time frame: Repeated measures: 0, 2, 4, 6 and 12 weeks

    Continuous measure

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Instituto Bairral de Psiquiatria
  • Stanley Medical Research Institute

Registry information

Official study title

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

Acronym: STARTS

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2015
Registry last updated
May 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.