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Schizophrenia TreAtment With electRic Transcranial Stimulation (STARTS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by University of Sao Paulo
Sponsor:
Collaborators:
Instituto Bairral de Psiquiatria
Stanley Medical Research Institute
Information provided by (Responsible Party):
Leandro Valiengo, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02535676
First received: August 26, 2015
Last updated: August 27, 2015
Last verified: August 2015
  Purpose

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 Assesment 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.


Condition Intervention Phase
Schizophrenia
Device: Transcranial Direct Current Stimulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Negative Symptoms of Schizophrenia With Transcranial Direct Current Stimulation (tDCS): A Randomized, Double-blinded, Sham-controlled, Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change in subscale of PANSS [ Time Frame: Repeated measures: 0, 2, 4 and 6 weeks (endpoint) ] [ Designated as safety issue: No ]
    Reduction of PANSS negative subscale (continuous measure) at 6 weeks


Secondary Outcome Measures:
  • Change in SANS [ Time Frame: Repeated measures: 0, 2, 4, 6 and 12 weeks ] [ Designated as safety issue: No ]
    Reduction of SANS (continuous measure)

  • Change in Negative subscale of PANSS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Reduction of PANSS negative subscale (continuous measure)

  • Change in Auditory Verbal Hallucination Scale [ Time Frame: Repeated measures: 0, 2, 4, 6 and 12 weeks ] [ Designated as safety issue: Yes ]
    Continuous measure


Estimated Enrollment: 100
Study Start Date: November 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Transcranial eletric stimulation

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02535676

Contacts
Contact: Leandro Valiengo, PhD +55 11 26618159 pesquisa.esquizofrenia@gmail.com

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil
Principal Investigator: Leandro Valiengo, MD         
Sponsors and Collaborators
University of Sao Paulo
Instituto Bairral de Psiquiatria
Stanley Medical Research Institute
Investigators
Principal Investigator: Leandro Valiengo, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Leandro Valiengo, Medical Assistance, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02535676     History of Changes
Other Study ID Numbers: 31063714.1.1001.0068
Study First Received: August 26, 2015
Last Updated: August 27, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
schizoprenia
transcranial stimulation

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 27, 2015