Long-Term Cariprazine Safe, Tolerable for Schizophrenia

Woman taking a pill
Woman taking a pill
Long-term treatment of schizophrenia with cariprazine was found to be both safe and well-tolerated.

Long-term treatment of schizophrenia with cariprazine was found to be both safe and well tolerated, according to a recent study published in BMC Psychiatry.

In this post hoc analysis of 2 open-label studies, researchers evaluated 679 adults with schizophrenia over 48 weeks. The pooled safety populations were evaluated for safety and tolerability within the overall cariprazine group as well as within dose groups (1.5-3, 4.5-6, and 9 mg per day; n=170, n=361, n=148, respectively).

A total of 272 participants (40.1%) completed the study, with a mean (standard deviation) treatment duration of 188.4 days (136.8). The 4.5- to 6-mg per day group had the longest treatment duration at 201.2 days (133.7).

Adverse events leading to discontinuation among ≥2% of participants in any dose group were akathisia (0.7% for overall cariprazine treatment), worsening schizophrenia (3.1%), and psychotic disorder (1.9%). Treatment-emergent adverse events reported in ≥10% of the overall cariprazine group were akathisia (15.5%), insomnia (13.3%), weight gain (10.5%), and headache (12.8%). Treatment-emergent extrapyramidal symptoms occurring in ≥5% of participants were akathisia (15.5%), tremor (6.9%), restlessness (5.6%), and extrapyramidal disorder (6.6%).

Across all dose groups, mean prolactin levels were reduced (-15.4 ng/mL for overall cariprazine treatment). Decreases in mean total cholesterol (-5.3 mg/dL) as well as low-density lipoprotein (-3.5 mg/dL) and high-density lipoprotein (-0.8 mg/dL) were noted for all dose groups, but no dose-response relationship was seen. Body weight increase of ≥7% occurred in 27% of patients, and a body weight decrease of ≥7% occurred in 11% (mean change 1.58 kg).

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The researchers concluded that long-term treatment with cariprazine for schizophrenia was “generally safe and well tolerated.” They further noted that the results “suggest that the complex pharmacokinetics of cariprazine did not appear to affect the long-term safety profile.”


Nasrallah HA, Earley W, Cutler AJ, et al. The safety and tolerability of cariprazine in long-term treatment of schizophrenia: a post hoc pooled analysis. BMC Psychiatry. 2017;17:305.