{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T07:16:34Z","timestamp":1788592594780,"version":"build-2803163510"},"reference-count":34,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2015,9,1]],"date-time":"2015-09-01T00:00:00Z","timestamp":1441065600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Child and Adolescent Psychopharmacology"],"published-print":{"date-parts":[[2015,9]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>The purpose of this study was to evaluate the long-term safety and tolerability of paliperidone extended-release (ER) in adolescents with schizophrenia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>This was a 2 year open-label, multicenter study in adolescents (12\u201317 years of age, inclusive) with schizophrenia. Eligible patients were initially treated with 6\u2009mg\/day paliperidone ER, and the dose could be adjusted between 1.5 and 12\u2009mg\/day based on clinical need. Safety parameters were treatment-emergent adverse events (TEAEs), weight, Tanner staging, blood chemistry (including prolactin, glucose, insulin, and lipid levels), and extrapyramidal symptom (EPS) scales. The main efficacy end-point was change from baseline to endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) total score.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Of 400 enrolled patients (mean age, 15.4 years; boys, 61%), 220 were completers. Median (range) exposure was 604.5 (2\u2013765) days. TEAEs were reported in 85.3% of patients; most frequently reported TEAEs included somnolence, increased weight, headache, insomnia, nasopharyngitis, akathisia, schizophrenia exacerbation, and tremor. No deaths were reported. There were no clinically significant mean changes in growth-adjusted\n                      <jats:italic toggle=\"yes\">z<\/jats:italic>\n                      score for change in weight, height, or body mass index (BMI). Tanner ratings showed normal maturation. Most frequently occurring EPS-related events were related to Parkinsonism (15.5%) and hyperkinesia (13.8%). No cases of tardive dyskinesia were reported. Hyperprolactinemia (based on laboratory values) was noted in 56% of patients and 9.3% of patients had prolactin-related TEAEs. A low percentage of patients (4.3%,\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      =14) had a shift from normal or impaired fasting glucose to high levels. Mean (SD) decrease (improvement) in PANSS total score from baseline to end-point was \u221219.1 (21.89). The majority of patients had a \u226520% improvement in PANSS total score (responders) from initial treatment with paliperidone ER. Overall, 41.7% of patients achieved remission during the study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>Paliperidone ER was generally tolerable, and exhibited efficacy in the maintenance treatment of schizophrenia in adolescents in this large 2 year study.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/cap.2014.0130","type":"journal-article","created":{"date-parts":[[2015,7,28]],"date-time":"2015-07-28T15:26:51Z","timestamp":1438097211000},"page":"548-557","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":21,"title":["Long-Term Safety of Paliperidone Extended Release in Adolescents with Schizophrenia: An Open-Label, Flexible Dose Study"],"prefix":"10.1177","volume":"25","author":[{"given":"Adam","family":"Savitz","sequence":"first","affiliation":[{"name":"Janssen Research & Development, LLC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosanne","family":"Lane","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isaac","family":"Nuamah","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jaskaran","family":"Singh","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Hough","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Srihari","family":"Gopal","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2015,9,1]]},"reference":[{"key":"e_1_3_3_2_1","doi-asserted-by":"publisher","DOI":"10.1089\/104454602760219126"},{"key":"e_1_3_3_3_1","unstructured":"American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders 4th ed. 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