The efficacy and safety of cariprazine in the early and late stage of schizophrenia: a post hoc analysis of three randomized, placebo-controlled trials

The aim of the post hoc analysis was to better understand the efficacy and safety of cariprazine in patients with schizophrenia for less than 5 years (early stage) and for more than 15 years (late stage). Data from three phase II/III randomized, double-blind, placebo-controlled trials with similar d...

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Bibliographic Details
Published in:CNS spectrums 2023-02, Vol.28 (1), p.104-111
Main Authors: Falkai, Peter, Dombi, Zsófia B., Acsai, Károly, Barabássy, Ágota, Schmitt, Andrea, Németh, György
Format: Article
Language:English
Subjects:
Antipsychotic Agents - adverse effects
Antipsychotics
Anxiety
Benzodiazepines
Clinical trials
Double-Blind Method
Double-blind studies
Hostility
Humans
Mental depression
Original Research
Piperazines - adverse effects
Psychosis
Remission (Medicine)
Schizophrenia
Schizophrenia - drug therapy
Treatment Outcome
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Summary:The aim of the post hoc analysis was to better understand the efficacy and safety of cariprazine in patients with schizophrenia for less than 5 years (early stage) and for more than 15 years (late stage). Data from three phase II/III randomized, double-blind, placebo-controlled trials with similar design in patients with acute exacerbation of schizophrenia were pooled and patients with early and late stage of schizophrenia were determined. A mixed-effects model for repeated measures approach was applied and least square (LS) mean changes from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) total and factor scores were reported. Descriptive statistics were used for safety analyses including treatment emergent adverse events (TEAEs) and discontinuation rates. Overall, 460 patients were identified as being in the early and 414 in the late stage of schizophrenia. The pooled analysis evaluating mean change from baseline to week 6 in the PANSS total score indicated statistically significant difference between cariprazine and placebo in favor of cariprazine in both the early (LS mean difference [LSMD] -7.5  
ISSN:1092-8529
2165-6509
DOI:10.1017/S1092852921000997