REAL-WORLD IMPACT ON ANXIETY SYMPTOMS OF CARIPRAZINE AS ADJUNCTIVE TREATMENT IN MAJOR DEPRESSIVE DISORDER OR MONOTHERAPY IN BIPOLAR I DISORDER

Introduction

Patients with major depressive disorder (MDD) or bipolar I disorder (BP-I) commonly experience anxiety symptoms. Cariprazine (CAR) is a dopamine D3-preferring D3/D2 and serotonin 5-HT1A receptor partial agonist approved for the treatment of manic/mixed and depressive episodes of BP-I and for the adjunctive treatment of MDD. This real-world study aimed to evaluate changes in anxiety symptoms over a 12-month period in patients diagnosed with MDD or BP-I prescribed CAR.

Methods

This retrospective cohort study analyzed electronic health records from NeuroBlu Data (1/1/2019 to 12/31/2024) to select adults with ≥2 diagnoses for either MDD or BP-I who were prescribed CAR (1st prescription=index date). Adjunctive CAR was required for patients with MDD, including both ≥1 prescription for antidepressant therapy (ADT) in the 12-months pre-index and co-prescription of ADT with CAR for ≥14 days post-index and the full duration of CAR exposure. Patients were required to have a Generalized Anxiety Disorder 7-item (GAD-7) score ≥10 (moderate to severe anxiety) ≤30 days pre-index (baseline) and ≥1 follow-up GAD-7 measure ≤12 months post-index, prior to the occurrence of any censoring event. Patients were excluded if they had a prior CAR prescription or schizophrenia diagnosis within 12 months preindex, concomitant antipsychotic use at index, or absence of MDD/BP-I diagnosis within 12 months pre-index. Follow-up was censored upon CAR discontinuation, new antipsychotic exposure, schizophrenia diagnosis, or the end of the study period. Outcomes included mean GAD-7 scores and mean change from baseline to 0-2, 2-6, and 6-12 months after index and were only evaluated for patients with data available during each time window. Lower scores indicate less severe anxiety. Responses to the 7 individual GAD-7 items were also analyzed in a subpopulation where item level data were available. Each item requires patients to indicate how frequently over the last 2 weeks they have experienced a particular symptom: “not at all,” “several days,” “more than half the days,” and “nearly every day.” Categorical variables were reported as proportions, while continuous variables were presented as means with 95% CIs.

Results

The final cohort included 252 patients at baseline (MDD, n=99; BP-I, n=153); the mean (SD) age was 39.5 (13.4) years and 76% were female. Mean GAD-7 scores improved from baseline for all time windows analyzed. From baseline, mean GAD-7 scores decreased from 16.3 to 12.7 at 0-2 months (n=190, mean change from baseline [95% CI]: -3.7 [-4.5, -2.8]); from 16.4 to 12.1 at 2-6 months (n=110, mean change [95% CI]: -4.3 [ 5.5, 3.1]); and from 15.9 to 11.8 at 6-12 months (n=52, mean change [95% CI]: -4.1 [-5.8, -2.4]). For patients with item-level scores available (0-2 months: n=59, 2-6 months: n=40, and 6-12 months: n=22) the proportion of patients reporting symptoms on “more than half the days” or “nearly every day” decreased from baseline for all items at 0-2 and 2-6 months; although the sample size at 6-12 months was smaller, a decrease was still seen on all items except for the ‘feeling afraid’ item, which increased slightly.

Conclusions

In real-world clinical practice, patients with MDD or BP-I prescribed CAR showed improvements from baseline in mean GAD-7 total scores at 0-2, 2-6, and 6-12 months. These findings suggest that CAR may be associated with improved anxiety symptoms when prescribed as adjunctive therapy in MDD or as monotherapy in BP-I.