Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study.

Abstract

RATIONALE:

Cariprazine, a dopamine D3/D2 receptor 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.

OBJECTIVE:

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

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

• Authors: Suresh Durgam, William M Greenberg, Dayong Li, Kaifeng Lu, Istvan Laszlovszky, Gyorgy Nemeth, Raffaele Migliore, Stephen Volk
• Journal: Psychopharmacology (Psychopharmacology (Berl)) Vol. 234 Issue 2 Pg. 199-209 (Jan 2017) ISSN: 1432-2072 [Electronic] Germany
• PMID: 27807604 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Antipsychotic Agents
• Piperazines
• cariprazine

Topics

• Adult
• Akathisia, Drug-Induced (diagnosis)
• Antipsychotic Agents (adverse effects, therapeutic use)
• Double-Blind Method
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Piperazines (adverse effects, therapeutic use)
• Schizophrenia (diagnosis, drug therapy)
• Time Factors
• Treatment Outcome
• Tremor (chemically induced, diagnosis)
• Weight Gain (drug effects)
• Young Adult