Effects of Cariprazine on Prolactin Levels in Patients With Bipolar I Disorder

Background: Antipsychotic treatment has been linked to hyperprolactinemia, which can lead to increased nonadherence and changes in sexual hormones in both men and women. Here, we evaluated the effects of cariprazine, a dopamine D3/D2 receptor partial agonist, on prolactin levels in patients with bipolar I disorder.

Methods: Effects on prolactin changes were evaluated using pooled data from randomized, double-blind, placebo-controlled studies in patients with bipolar depression (3 studies; 6- to 8- week duration; cariprazine 0.75, 1.5, 3, and pooled 0.75-3 mg/d) or manic/mixed bipolar episodes (3 studies; 3-week duration; cariprazine 3-12 mg/d). Long-term effects of cariprazine (3-12 mg/d) were analyzed during a 16-week open label bipolar mania study. Change in prolactin levels from baseline to study endpoint was evaluated in both male and female subpopulations.

Results: In male patients with bipolar depression (n=526), mean (SD) changes in prolactin levels were -1.6 (12.8) ng/mL for placebo and ranged from -0.6 (4.6) to +0.6 (6.6) ng/mL across cariprazine treatment groups. In female patients with bipolar depression (n=858), mean prolactin changes were +0.2 (12.8) ng/mL for placebo and ranged from -0.5 (28.6) to +1.3 (26.7) ng/mL for the cariprazine treatment groups. In patients with bipolar mania, mean changes in prolactin for placebo and cariprazine were -2.7 (12.9) and -5.8 (12.8) ng/mL in males (n=633) and -11.6 (30.9) and -8.0 (36.5) ng/mL for females (n=432), respectively; mean prolactin levels also slightly decreased during the 16-week study (N=402; -3.8 [17.8] ng/mL).

Conclusions: Cariprazine demonstrated minimal effects on prolactin levels in patients with bipolar I disorder.

This poster was presented at the 32nd annual Psych Congress, held Oct. 3-6, 2019, in San Diego, California.