PMID- 35133884 OWN - NLM STAT- MEDLINE DCOM- 20220317 LR - 20220317 IS - 1557-8992 (Electronic) IS - 1044-5463 (Print) IS - 1044-5463 (Linking) VI - 32 IP - 1 DP - 2022 Feb TI - Efficacy and Safety of Blonanserin Oral Tablet in Adolescents with Schizophrenia: A 6-Week, Randomized Placebo-Controlled Study. PG - 12-23 LID - 10.1089/cap.2021.0013 [doi] AB - Objectives: To evaluate the short-term efficacy and safety of blonanserin in adolescents with schizophrenia. Methods: This 6-week multicenter, double-blind, randomized, placebo-controlled study investigated fixed-dose blonanserin (8 or 16 mg/day) in patients 12-18 years of age diagnosed with schizophrenia, as indicated by a Positive and Negative Syndrome Scale (PANSS) total score of 60-120 and a Clinical Global Impressions-Severity score of >/=3. The primary endpoint was change from baseline to week 6 in the PANSS total score, using a mixed model for repeated measures analysis. Safety was assessed by the incidence and severity of adverse events (AEs). Results: Among 151 randomized patients, 150 were included in the primary analysis population. Demographic and clinical characteristics were similar across groups at baseline. The rate of study discontinuation was 14.9%, 23.5%, and 28.3% in patients administered with placebo, blonanserin 8 mg/day, and blonanserin 16 mg/day, respectively. The least-squares mean change (95% confidence interval [CI]) from baseline to week 6 in PANSS total score was -10.6 (-16.10 to -5.10), -15.3 (-20.80 to -9.86), and -20.5 (-25.89 to -15.16) in patients administered placebo, 8 mg/day blonanserin, and 16 mg/day blonanserin, respectively. The 16-mg/day blonanserin group showed significantly greater reduction in the PANSS total score than the placebo group (least-squares mean difference [95% CI]: -9.9 [-17.61 to -2.25], p = 0.012, effect size: 0.538), although the 8-mg/day group showed no significant difference. The incidence of AEs such as akathisia, somnolence, and hyperprolactinemia was higher in the blonanserin groups than in the placebo group. AEs associated with blonanserin were generally mild and were consistent with its known profile in adults with schizophrenia. Conclusions: Blonanserin achieved a sufficient efficacy in adolescent patients, and the safety profile was similar to that in adults, which suggests that blonanserin may be a safe treatment option for adolescents with schizophrenia. Study registration number: Japic CTI-111724. FAU - Saito, Takuya AU - Saito T AD - Department of Child and Adolescent Psychiatry, Hokkaido University Hospital, Sapporo, Japan. FAU - Sugimoto, Saori AU - Sugimoto S AD - Sumitomo Dainippon Pharma Co., Ltd., Chuo-ku, Tokyo, Japan. FAU - Sakaguchi, Reiko AU - Sakaguchi R AD - Sumitomo Dainippon Pharma Co., Ltd., Chuo-ku, Tokyo, Japan. FAU - Nakamura, Hiroshi AU - Nakamura H AUID- ORCID: 0000-0001-7699-9840 AD - Sumitomo Dainippon Pharma Co., Ltd., Chuo-ku, Tokyo, Japan. FAU - Ishigooka, Jun AU - Ishigooka J AD - Institute of CNS Pharmacology, Shibuya-ku, Tokyo, Japan. LA - eng SI - JapicCTI/Japic CTI-111724 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20220208 PL - United States TA - J Child Adolesc Psychopharmacol JT - Journal of child and adolescent psychopharmacology JID - 9105358 RN - 0 (Antipsychotic Agents) RN - 0 (Piperazines) RN - 0 (Piperidines) RN - 0 (Tablets) RN - AQ316B4F8C (blonanserin) SB - IM MH - Adolescent MH - Adult MH - *Antipsychotic Agents/adverse effects MH - Double-Blind Method MH - Humans MH - Piperazines/adverse effects MH - Piperidines MH - *Schizophrenia/drug therapy MH - Tablets/therapeutic use MH - Treatment Outcome PMC - PMC8884167 OTO - NOTNLM OT - adolescent OT - antipsychotics OT - blonanserin OT - schizophrenia COIS- Sumitomo Dainippon Pharma makes individual patient, deidentified datasets and associated clinical documents, such as study protocol, statistical analysis plan, and clinical study report available upon request through the Clinical Study Data Request site (https://www.clinicalstudydatarequest.com/Study-Sponsors.aspx) within 12 months of posting the study results on clininicaltrials.gov. Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months. EDAT- 2022/02/09 06:00 MHDA- 2022/03/18 06:00 PMCR- 2022/02/14 CRDT- 2022/02/08 17:12 PHST- 2022/02/09 06:00 [pubmed] PHST- 2022/03/18 06:00 [medline] PHST- 2022/02/08 17:12 [entrez] PHST- 2022/02/14 00:00 [pmc-release] AID - 10.1089/cap.2021.0013 [pii] AID - 10.1089/cap.2021.0013 [doi] PST - ppublish SO - J Child Adolesc Psychopharmacol. 2022 Feb;32(1):12-23. doi: 10.1089/cap.2021.0013. Epub 2022 Feb 8.