Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study.
Cariprazine, a dopamine D3/D2receptor partial agonist antipsychotic, demonstrated efficacy and tolerability in 6-week, randomized, placebo-controlled schizophrenia trials. Schizophrenia is a chronic disorder that requires continuous treatment; therefore, the long-term safety and tolerability profile of antipsychotic agents is an important factor in guiding clinician decisions.



This single-arm, open-label extension study evaluated the long-term safety and tolerability of cariprazine in patients with schizophrenia.



Patients enrolled in this study completed a 6-week, randomized, placebo- and active-controlled study and had responded (Clinical Global Impressions-Severity [CGI-S] ≤3; ≥20 % reduction in Positive and Negative Syndrome Scale [PANSS] total score) to treatment at the end of the lead-in study. Patients (N = 93) received flexibly dosed, open-label cariprazine (1.5-4.5 mg/day) for up to 48 weeks.



Approximately 50 % (46/93) of patients completed the 48 weeks of open-label treatment. The most common adverse events (AEs) were akathisia (14 %), insomnia (14 %), and weight increased (12 %). Serious AEs (SAEs) occurred in 13 % of patients; 11 % discontinued due to AEs. Mean changes in metabolic parameters were generally small and not clinically relevant. Mean body weight increased by 1.9 kg from the start of the lead-in study to the end of the extension study. There were no discontinuations associated with change in metabolic parameters or body weight. Long-term cariprazine treatment was not associated with prolactin elevation or clinically significant changes in cardiovascular parameters.



In this 48-week, single-arm trial, open-label cariprazine (1.5-4.5 mg/day) treatment was generally safe and well tolerated with no new safety concerns associated with long-term treatment.
Allergan, Jersey City, NJ, USA. suresh.durgam@allergan.com.
Suresh
S
Durgam
Allergan, Jersey City, NJ, USA.
William M
WM
Greenberg
Allergan, Jersey City, NJ, USA.
Dayong
D
Li
Allergan, Jersey City, NJ, USA.
Kaifeng
K
Lu
Gedeon Richter Plc, Budapest, Hungary.
Istvan
I
Laszlovszky
Gedeon Richter Plc, Budapest, Hungary.
Gyorgy
G
Nemeth
Allergan, Jersey City, NJ, USA.
Raffaele
R
Migliore
Apostle Clinical Trials, Long Beach, CA, USA.
Stephen
S
Volk
D000328:Adult; D017109:Akathisia, Drug-Induced / Q000175:diagnosis; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000175:diagnosis* / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D014202:Tremor / Q000139:chemically induced / Q000175:diagnosis; D015430:Weight Gain / Q000187:drug effects; D055815:Young Adult
D014150:Antipsychotic Agents; D010879:Piperazines; C533287:cariprazine
Atypical antipsychotic; Cariprazine; Dopamine antagonist; Open-label; Safety; Schizophrenia