Minimal Effects of Cariprazine on Prolactin Levels in Bipolar Disorder and Schizophrenia

Larry Culpepper; Eduard Vieta; Deanna L Kelly; Mehul D Patel; Balázs Szatmári; Arlene Hankinson; Willie R Earley

doi:10.2147/NDT.S348143

Minimal Effects of Cariprazine on Prolactin Levels in Bipolar Disorder and Schizophrenia

Neuropsychiatr Dis Treat. 2022 May 12:18:995-1011. doi: 10.2147/NDT.S348143. eCollection 2022.

Authors

Larry Culpepper¹, Eduard Vieta², Deanna L Kelly³, Mehul D Patel⁴, Balázs Szatmári⁵, Arlene Hankinson⁴, Willie R Earley⁴

Affiliations

¹ Boston University School of Medicine, Boston, MA, USA.
² Hospital Clinic, Institute of Neuroscience, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
³ Maryland Psychiatric Research Center, University of Maryland School of Medicine, Baltimore, MD, USA.
⁴ AbbVie, Madison, NJ, USA.
⁵ Gedeon Richter Plc., Budapest, Hungary.

Abstract

Background: Many medications used to treat schizophrenia and bipolar I disorder are linked to hyperprolactinemia. The effects of cariprazine, a dopamine D₃/D₂ receptor partial agonist, on prolactin levels in patients with schizophrenia or bipolar I disorder were evaluated.

Methods: Effects on prolactin were evaluated using pooled data from randomized, double-blind, placebo-controlled studies in patients with schizophrenia (4 studies; 6-week duration; cariprazine 1.5-3 mg/d, 4.5-6 mg/d, and 9-12 mg/d), bipolar mania (3 studies; 3-week duration; cariprazine 3-6 and 9-12 mg/d), and bipolar depression (3 studies; 6- to 8-week duration; cariprazine 1.5 and 3 mg/d). Long-term effects were analyzed using open-label studies in patients with schizophrenia (2 studies; 48-week duration) and patients with bipolar mania (1 study; 16-week duration). Change in prolactin levels (ng/mL) from baseline to study endpoint was evaluated in subsets of sex and prior medication use.

Results: In patients with schizophrenia (male, n = 1377; female, n = 558), median prolactin changes were -1.2 for males and -7.4 for females on placebo, and ranged from -4.2 to -3.6 for males and -12.4 to +0.2 for females in the cariprazine-treatment groups. In patients with bipolar mania (male, n = 570; female, n = 395), median prolactin changes were -0.2 for males and -1.1 for females on placebo and ranged from -2.1 to -3.0 for males and 0 to +1.8 for females in the cariprazine-treatment groups. Median decreases were also seen in the long-term studies of schizophrenia (range, -14.6 to -2.0) and bipolar mania (range, -0.8 to +1.9). In patients with bipolar depression (male, n = 485; female, n = 780), median prolactin changes were +0.3 for males and +0.7 for females on placebo and ranged from +0.4 to +0.5 for males and +3.0 to +3.1 for females in the cariprazine-treatment groups.

Conclusion: Treatment with cariprazine for schizophrenia or bipolar I disorder was associated with minimal effects on prolactin levels.

Keywords: depression; dopamine; mania; prolactin; serotonin.

Grants and funding

This study was funded by AbbVie, Inc.