NYMC Faculty Publications
Cariprazine and Akathisia, Restlessness, and Extrapyramidal Symptoms in Patients with Bipolar Depression
Author Type(s)
Faculty
Journal Title
Journal of Affective Disorders
First Page
191
Last Page
198
Document Type
Article
Publication Date
6-1-2021
Department
Psychiatry and Behavioral Sciences
Abstract
BACKGROUND: Akathisia is a neuropsychiatric syndrome that is commonly related to the use of dopamine receptor antagonists/partial agonists. The characteristics of cariprazine-related akathisia, restlessness, and extrapyramidal symptoms (EPS) were investigated in patients with bipolar I depression.
METHODS: Akathisia-related data from 3 fixed-dose clinical studies of cariprazine 1.5 mg/d and 3 mg/d in bipolar depression were evaluated in pooled post hoc analyses. Outcomes related to treatment-emergent adverse events (TEAEs) included incidence, time to onset, time to resolution, severity, discontinuations, and rescue medication use.
RESULTS: The incidence of akathisia was 7.6% for overall cariprazine (1.5 mg/d=5.5%; 3 mg/d=9.6%) and 2.1% for placebo; acute EPS occurred in 4.5% of cariprazine-treated (1.5 mg/d=3.8%; 3 mg/d=5.1%) and 2.1% of placebo-treated patients. Findings were similar for restlessness. Most TEAEs were mild/moderate (>95%), occurred during the first 3 weeks of cariprazine initiation or dose increase, and resulted in few discontinuations (
LIMITATIONS: Post hoc analyses; no active comparator.
CONCLUSIONS: In patients with bipolar depression, the incidence of cariprazine-related akathisia was higher than acute EPS or restlessness, with lower cariprazine doses associated with lower incidences of events. Akathisia and EPS TEAEs occurred early in treatment and were mild/moderate in severity. Few patients with akathisia or acute EPS discontinued treatment. Cariprazine-related akathisia and EPS can be minimized with conservative dosing and titration strategies.
TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT01396447, NCT02670538, NCT02670551.
Recommended Citation
Citrome, L., Yatham, L. N., Patel, M. D., Barabássy, Á., Hankinson, A., & Earley, W. R. (2021). Cariprazine and Akathisia, Restlessness, and Extrapyramidal Symptoms in Patients with Bipolar Depression. Journal of Affective Disorders, 288, 191-198. https://doi.org/10.1016/j.jad.2021.03.076
