We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia: A Randomized Clinical Trial.
- Authors
Valiengo, Leandro da Costa Lane; Goerigk, Stephan; Gordon, Pedro Caldana; Padberg, Frank; Serpa, Mauricio Henriques; Koebe, Stephanie; Santos, Leonardo Afonso dos; Lovera, Roger Alberto Marcos; Carvalho, Juliana Barbosa de; van de Bilt, Martinus; Lacerda, Acioly L. T.; Elkis, Helio; Gattaz, Wagner Farid; Brunoni, Andre R.
- Abstract
<bold>Importance: </bold>Negative symptoms represent a substantial burden in schizophrenia. Although preliminary studies have suggested that transcranial direct current stimulation (tDCS) is effective for some clusters of symptoms, the clinical benefits for negative symptoms are unclear.<bold>Objective: </bold>To determine the efficacy and safety of tDCS vs sham as an add-on treatment for patients with schizophrenia and predominant negative symptoms.<bold>Design, Setting, and Participants: </bold>The double-blind Schizophrenia Treatment With Electric Transcranial Stimulation (STARTS) randomized clinical trial was conducted from September 2014 to March 2018 in 2 outpatient clinics in the state of São Paulo, Brazil. Patients with schizophrenia with stable negative and positive symptoms and a minimum score of 20 points in the negative symptoms subscale of the Positive and Negative Syndrome Scale (PANSS) were included.<bold>Interventions: </bold>Ten sessions of tDCS performed twice a day for 5 days or a sham procedure. The anode and the cathode were positioned over the left prefrontal cortex and the left temporoparietal junction, respectively.<bold>Main Outcomes and Measures: </bold>Change in the PANSS negative symptoms subscale score at week 6 was the primary outcome. Patients were followed-up for an additional 6 weeks.<bold>Results: </bold>Of the 100 included patients, 20 (20.0%) were female, and the mean (SD) age was 35.3 (9.3) years. A total of 95 patients (95.0%) finished the trial. In the intention-to-treat analysis, patients receiving active tDCS showed a significantly greater improvement in PANSS score compared with those receiving the sham procedure (difference, 2.65; 95% CI, 1.51-3.79; number needed to treat, 3.18; 95% CI, 2.12-6.99; P < .001). Response rates for negative symptoms (20% improvement or greater) were also higher in the active group (20 of 50 [40%]) vs the sham group (2 of 50 [4%]) (P < .001). These effects persisted at follow-up. Transcranial direct current stimulation was well tolerated, and adverse effects did not differ between groups, except for burning sensation over the scalp in the active group (43.8%) vs the sham group (14.3%) (P = .003).<bold>Conclusions and Relevance: </bold>Transcranial direct current stimulation was effective and safe in ameliorating negative symptoms in patients with schizophrenia.<bold>Trial Registration: </bold>ClinicalTrials.gov identifier: NCT02535676.
- Subjects
SAO Paulo (Brazil); TRANSCRANIAL direct current stimulation; CLINICAL trials; ELECTRIC stimulation; SCHIZOPHRENIA; TEMPOROPARIETAL junction; SCHIZOPHRENIA treatment; CONFIDENCE intervals; PSYCHOLOGICAL tests; TREATMENT effectiveness; RANDOMIZED controlled trials; BLIND experiment; COMBINED modality therapy; STATISTICAL sampling; ANTIPSYCHOTIC agents
- Publication
JAMA Psychiatry, 2020, Vol 77, Issue 2, p121
- ISSN
2168-622X
- Publication type
journal article
- DOI
10.1001/jamapsychiatry.2019.3199