PMID- 28478771 OWN - NLM STAT- MEDLINE DCOM- 20191001 LR - 20191001 IS - 1092-8529 (Print) IS - 1092-8529 (Linking) VI - 23 IP - 1 DP - 2018 Feb TI - Evaluation of the long-term safety and tolerability of cariprazine in patients with schizophrenia: results from a 1-year open-label study. PG - 39-50 LID - 10.1017/S1092852917000220 [doi] AB - OBJECTIVE: Cariprazine, a dopamine D3/D2 partial agonist atypical antipsychotic with preferential binding to D3 receptors, is approved for the treatment of schizophrenia and manic or mixed episodes associated with bipolar I disorder. The efficacy and safety of cariprazine was established in three randomized, double-blind, placebo-controlled, 6-week trials in patients with acute exacerbation of schizophrenia. This 53-week study evaluated the long-term safety and tolerability of cariprazine in patients with schizophrenia. METHODS: This was a multicenter, open-label, flexible-dose study of cariprazine 3-9 mg/d in adults with schizophrenia. Participants included new patients and patients who had completed one of two phase III lead-in studies (NCT01104766, NCT01104779). Eligible patients entered a no-drug screening period of up to 1 week followed by 48 weeks of flexibly dosed, open-label cariprazine treatment (3-9 mg/d) and 4 weeks of safety follow-up. RESULTS: A total of 586 patients received open-label cariprazine treatment, ~39% of whom completed the study. No unexpected safety issues or deaths were reported. The most common (>/=10%) adverse events (AEs) observed were akathisia (16%), headache (13%), insomnia (13%), and weight gain (10%). Serious AEs occurred in 59 (10.1%) patients, and 73 (12.5%) patients discontinued the study due to AEs during open-label treatment. Mean changes in metabolic, hepatic, and cardiovascular parameters were not considered clinically relevant. Mean body weight increased by 1.5 kg during the study, prolactin levels decreased slightly, and measures of efficacy remained stable. CONCLUSIONS: Long-term cariprazine treatment at doses up to 9 mg/d appeared to be generally safe and well tolerated in patients with schizophrenia. FAU - Cutler, Andrew J AU - Cutler AJ AD - 1Meridien Research Inc.,Bradenton,Florida,USA. FAU - Durgam, Suresh AU - Durgam S AD - 2Allergan,Jersey City,New Jersey,USA. FAU - Wang, Yao AU - Wang Y AD - 3Allergan,Jersey City,New Jersey,USA(at the time of the study). FAU - Migliore, Raffaele AU - Migliore R AD - 2Allergan,Jersey City,New Jersey,USA. FAU - Lu, Kaifeng AU - Lu K AD - 2Allergan,Jersey City,New Jersey,USA. FAU - Laszlovszky, Istvan AU - Laszlovszky I AD - 4Gedeon Richter Plc.,Budapest,Hungary. FAU - Nemeth, Gyorgy AU - Nemeth G AD - 4Gedeon Richter Plc.,Budapest,Hungary. LA - eng SI - ClinicalTrials.gov/NCT01104766 SI - ClinicalTrials.gov/NCT01104779 PT - Clinical Trial, Phase III PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20170508 PL - United States TA - CNS Spectr JT - CNS spectrums JID - 9702877 RN - 0 (Antipsychotic Agents) RN - 0 (Piperazines) RN - F6RJL8B278 (cariprazine) SB - IM MH - Adult MH - Antipsychotic Agents/administration & dosage/*adverse effects/therapeutic use MH - Female MH - Headache/etiology MH - Humans MH - Male MH - Maximum Tolerated Dose MH - Middle Aged MH - Piperazines/administration & dosage/*adverse effects/therapeutic use MH - Psychomotor Agitation/etiology MH - Schizophrenia/*drug therapy MH - Sleep Initiation and Maintenance Disorders/etiology MH - Weight Gain OTO - NOTNLM OT - Cariprazine OT - antipsychotics OT - dopamine receptors OT - long-term safety OT - schizophrenia EDAT- 2017/05/10 06:00 MHDA- 2019/10/02 06:00 CRDT- 2017/05/09 06:00 PHST- 2017/05/10 06:00 [pubmed] PHST- 2019/10/02 06:00 [medline] PHST- 2017/05/09 06:00 [entrez] AID - S1092852917000220 [pii] AID - 10.1017/S1092852917000220 [doi] PST - ppublish SO - CNS Spectr. 2018 Feb;23(1):39-50. doi: 10.1017/S1092852917000220. Epub 2017 May 8.