Schizophrenia TreAtment with electRic Transcranial Stimulation (STARTS): design, rationale and objectives of a randomized, double-blinded, sham-controlled trial

Schizophrenia is a severe mental disorder. While some antipsychotic medications have demonstrated efficacy in treating positive symptoms, there is no widely recognized treatment for negative symptoms, which can cause significant distress and impairment for patients with schizophrenia. Here we descri...

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Bibliographic Details
Published in:	Trends in psychiatry and psychotherapy Vol. 41; no. 2; pp. 104 - 111
Main Authors:	Valiengo, Leandro, Gordon, Pedro Caldana, de Carvalho, Juliana Barbosa, Rios, Rosa Maria, Koebe, Stephanie, Serpa, Mauricio Henrique, van de Bilt, Martinus, Lacerda, Acioly, Elkis, Helio, Gattaz, Wagner Farid, Brunoni, André Russowsky
Format:	Journal Article
Language:	English
Published:	Brazil Associação de Psiquiatria do Rio Grande do Sul - Trends in Psychiatry and Psychotherapy 01-04-2019 Associação de Psiquiatria do Rio Grande do Sul
Subjects:	Adolescent Adult Aged Antipsychotics Biomarkers Clinical trials Double-Blind Method Electric stimulation therapy Electrical stimulation of the brain Emotional behavior ensaio clínico randomizado ESB Esquizofrenia estimulação transcraniana Excitability Female Humans Interleukins Male marcadores biológicos Mental disorders Middle Aged Neuropsychological Tests Neurotrophic factors Patients Prefrontal Cortex PSYCHIATRY Randomized Controlled Trials as Topic Schizophrenia Schizophrenia - therapy terapia de estimulação elétrica Transcranial Direct Current Stimulation - methods Transcranial magnetic stimulation Treatment Outcome Young Adult Esquizofrenia marcadores biológicos Schizophrenia electric stimulation therapy biological markers ensaio clínico randomizado transcranial stimulation estimulação transcraniana terapia de estimulação elétrica randomized controlled trial
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Summary:	Schizophrenia is a severe mental disorder. While some antipsychotic medications have demonstrated efficacy in treating positive symptoms, there is no widely recognized treatment for negative symptoms, which can cause significant distress and impairment for patients with schizophrenia. Here we describe the rationale and design of the STARTS study (Schizophrenia TreAtment with electRic Transcranial Stimulation), a clinical trial aimed to test the efficacy of a non-pharmacological treatment known as transcranial direct current stimulation (tDCS) for treating the negative symptoms of schizophrenia. The STARTS study is designed as a randomized, sham-controlled, double-blinded trial evaluating tDCS for the treatment of the negative symptoms of schizophrenia. One-hundred patients will be enrolled and submitted to 10 tDCS sessions over the left dorsolateral prefrontal cortex (anodal stimulation) and left temporoparietal junction (cathodal stimulation) over 5 consecutive days. Participants will be assessed using clinical and neuropsychological tests before and after the intervention. The primary outcome is change in the Positive and Negative Syndrome Scale (PANSS) negative subscale score over time and across groups. Biological markers, including blood neurotrophins and interleukins, genetic polymorphisms, and motor cortical excitability, will also be assessed. The clinical results will provide insights about tDCS as a treatment for the negative symptoms of schizophrenia, and the biomarker investigation will contribute towards an improved understanding of the tDCS mechanisms of action. Our results could introduce a novel therapeutic technique for the negative symptoms of schizophrenia. Clinical trial registration: ClinicalTrials.gov, NCT02535676 .
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	2237-6089 2238-0019 2238-0019
DOI:	10.1590/2237-6089-2018-0047