Schizophrenia TreAtment With electRic Transcranial Stimulation

NCT02535676 | Completed Phase 3

• 1 other identifier: 31063714.1.1001.0068
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

schizophrenia; transcranial stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in SANS

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

• Change in Negative subscale of PANSS

  12 weeks

• Change in Auditory Verbal Hallucination Scale

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

Study Arms (2)

Active tDCS

ACTIVE COMPARATOR

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

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.

Also known as: Transcranial eletric stimulation

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Instituto Bairral de Psiquiatria: collaborator
• Stanley Medical Research Institute: collaborator

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, Brazil

Location

Related Publications (3)

• Bulubas L, Goerigk S, Gomes JS, Brem AK, Carvalho JB, Pinto BS, Elkis H, Gattaz WF, Padberg F, Brunoni AR, Valiengo L. Cognitive outcomes after tDCS in schizophrenia patients with prominent negative symptoms: Results from the placebo-controlled STARTS trial. Schizophr Res. 2021 Sep;235:44-51. doi: 10.1016/j.schres.2021.07.008. Epub 2021 Jul 22.

  PMID: 34304146 DERIVED

• Valiengo LDCL, Goerigk S, Gordon PC, Padberg F, Serpa MH, Koebe S, Santos LAD, Lovera RAM, Carvalho JB, van de Bilt M, Lacerda ALT, Elkis H, Gattaz WF, Brunoni AR. Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):121-129. doi: 10.1001/jamapsychiatry.2019.3199.

  PMID: 31617873 DERIVED

• Valiengo L, Gordon PC, de Carvalho JB, Rios RM, Koebe S, Serpa MH, van de Bilt M, Lacerda A, Elkis H, Gattaz WF, Brunoni AR. Schizophrenia TreAtment with electRic Transcranial Stimulation (STARTS): design, rationale and objectives of a randomized, double-blinded, sham-controlled trial. Trends Psychiatry Psychother. 2019 Jun 19;41(2):104-111. doi: 10.1590/2237-6089-2018-0047.

  PMID: 31241683 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Leandro Valiengo, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Assistance

Study Record Dates

• First Submitted: August 26, 2015
• First Posted: August 28, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

BR (1)