a study of cariprazine in the prevention of relapse of symptoms in participants with schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.

there were 3 periods (phases) in the study. the open-label phase lasted 20 weeks. in the first 6 weeks, participants received 3, 6, or 9 mg cariprazine orally once a day; the dose could be modified during this time. the cariprazine dose was fixed at 3, 6, or 9 mg for the last 14 weeks of this open-label phase. at the end of week 8, participants had to meet the following criteria to continue in the study. * positive and negative syndrome scale (panss) total score ≤ 60 at the end of week 8 * at least 20% decrease in panss total score from baseline to the end of week 8 * clinical global impressions - severity (cgi-s) score ≤ 4 at the end of week 8 * score of ≤ 4 on each of the following 7 panss items: p1, p2, p3, p6, p7, g8, and g14 at the end of week 8 * stable dose during the previous 2 weeks * no significant tolerability issues as judged by the investigator at the end of week 8 at the end of the open-label phase, participants were randomized into 2 treatment groups, cariprazine or placebo, if they met the following criteria: * panss total score ≤ 60 at the end of week 20 * at least 20% decrease in panss total score from baseline to the end of week 20 * cgi-s score ≤ 4 at the end of week 20 * score of ≤ 4 on each of the following 7 panss items: p1, p2, p3, p6, p7, g8, and g14 at the end of week 20 * no significant tolerability issues as judged by the investigator during this double-blind treatment phase, participants received either placebo or cariprazine at the same dosage (3, 6, or 9 mg) that they received during the last 14 weeks of the open-label phase. all participants entered the 4 week safety follow-up phase. they received a treatment other than the investigational product at the discretion of the investigator.

Eligibility criteria:
inclusion criteria: * participants who have provided informed consent prior to any study specific procedures. * participants currently meeting the diagnostic and statistical manual of mental disorders, fourth edition - text revision (dsm-iv-tr) criteria for schizophrenia. * participants with normal physical examination, laboratory, vital signs, and/or electrocardiogram (ecg). * diagnosis of schizophrenia for a minimum of 1 year before visit 1 (screening). * positive and negative syndrome scale (panss) total score ≥ to 70 and ≤ 120 at visit 1 (screening) and visit 2 (beginning of run-in phase). * negative serum b-human chorionic gonadotropin (b-hcg) pregnancy test (applies to female participants of childbearing potential only). * body mass index between 18 and 40 kg/m\^2, inclusive. exclusion criteria: * participants currently meeting dsm-iv-tr criteria for schizoaffective disorder, schizophreniform disorder, bipolar i and ii and known or suspected borderline or antisocial personality disorder. or other dsm-iv-tr axis ii disorders. * participants in their first episode of psychosis. * treatment-resistant schizophrenia over the last 2 years. * positive result from the blood alcohol test or from the urine drug screen for any prohibited medication. * at imminent risk of injuring self or others or causing significant damage to property. * suicide risk.

Keywords: schizophrenia schizophrenic disorder