Schizophrenia TreAtment With electRic Transcranial Stimulation (STARTS)

University of Sao Paulo

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Device: Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02535676

31063714.1.1001.0068

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Active tDCS

Active Comparator group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation

Sham tDCS

Sham Comparator group

Description:

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.

Treatment:

Device: Transcranial Direct Current Stimulation