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Psychopharmacology (Berl). 2017 Jan;234(2):199-209. doi: 10.1007/s00213-016-4450-3. Epub 2016 Nov 2.

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

Author information

1
Allergan, Jersey City, NJ, USA. suresh.durgam@allergan.com.
2
Allergan, Jersey City, NJ, USA.
3
Gedeon Richter Plc, Budapest, Hungary.
4
Apostle Clinical Trials, Long Beach, CA, USA.

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.

KEYWORDS:

Atypical antipsychotic; Cariprazine; Dopamine antagonist; Open-label; Safety; Schizophrenia

PMID:
27807604
PMCID:
PMC5203812
DOI:
10.1007/s00213-016-4450-3
[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Conflict of interestSuresh Durgam, William M. Greenberg, Dayong Li, Kaifeng Lu, and Raffaele Migliore acknowledge a potential conflict of interest as current or former employees of Allergan. István Laszlovszky acknowledges a potential conflict of interest as an employee of Gedeon Richter Plc. Stephen Volk has received grant/research support from Eli Lilly, Forest Laboratories, Inc., Merck, Otsuka Pharmaceuticals, and Sunovion Pharmaceuticals and is a stock shareholder for MannKind Corporation and Arena Pharmaceuticals.Source of funding and material supportThis work was supported by funding from Forest Research Institute, Inc., an Allergan affiliate (Jersey City, New Jersey), and Gedeon Richter Plc. (Budapest, Hungary). Forest Laboratories, LLC and Gedeon Richter Plc. were involved in the study design, collection (via contracted clinical investigator sites), analysis and interpretation of data, and the decision to present these results. The authors have full control of all data and agree to allow the journal to review the data if requested.

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