Clinical trial NCT02535676: Schizophrenia TreAtment With electRic Transcranial Stimulation
Official title: Treatment of Negative Symptoms of Schizophrenia With Transcranial Direct Current Stimulation (tDCS): A Randomized, Double-blinded, Sham-controlled, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
transcranial stimulation
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Instituto Bairral de Psiquiatria
name: Stanley Medical Research Institute
First posted: 2015-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in subscale of PANSS
timeFrame: Repeated measures: 0, 2, 4 and 6 weeks (endpoint)
Secondary outcomes:
measure: Change in SANS
timeFrame: Repeated measures: 0, 2, 4, 6 and 12 weeks
measure: Change in Negative subscale of PANSS
timeFrame: 12 weeks
measure: Change in Auditory Verbal Hallucination Scale
timeFrame: Repeated measures: 0, 2, 4, 6 and 12 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Leandro Valiengo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.