Cariprazine efficacy in bipolar I depression with and without concurrent manic symptoms: post hoc analysis of 3 randomized, placebo-controlled studies
RS McIntyre, T Suppes, W Earley, M Patel… - CNS spectrums, 2020 - cambridge.org
RS McIntyre, T Suppes, W Earley, M Patel, SM Stahl
CNS spectrums, 2020•cambridge.orgObjective. Mixed presentations, defined by simultaneous occurrence of depressive and
manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak
evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled
post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar
depression with or without concurrent manic symptoms. Methods. Patients from 3
randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria …
manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak
evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled
post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar
depression with or without concurrent manic symptoms. Methods. Patients from 3
randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria …
Objective
Mixed presentations, defined by simultaneous occurrence of depressive and manic symptoms, are difficult to treat. Antidepressants, although commonly used, have weak evidence of efficacy and may increase risk of mood destabilization. The aim of this pooled post hoc analysis was to evaluate the efficacy of cariprazine in the treatment of bipolar depression with or without concurrent manic symptoms.
Methods
Patients from 3 randomized, double-blind, placebo-controlled studies who met DSM-IV-TR or DSM-5 criteria for bipolar I disorder with a current major depressive episode were identified to have concurrent manic symptoms by baseline Young Mania Rating Scale total score ≥4. Efficacy was assessed in cariprazine 1.5 and 3 mg/day dose groups versus placebo; analyses included the least squares mean change from baseline to week 6 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Results
Of 1383 patients randomized to treatment, 808 (58.4%) had concurrent manic symptoms. For patients with manic symptoms, mean reduction in MADRS total score from baseline to week 6 was significantly greater for both cariprazine 1.5 and 3 mg/day compared with placebo, with least squares mean differences (LSMDs) versus placebo of −2.5 (p = .0033) and −2.9 (p = .0010), respectively; for patients without manic symptoms, the LSMD was significant for 1.5 mg/day (−3.3; p = .0008), but not for 3 mg/day (−1.9; p = .0562).
Conclusion
The results of this post hoc analysis suggest that cariprazine may be an appropriate treatment option for patients with bipolar I depression with or without manic symptoms, with higher doses potentially more effective in patients with manic symptoms.
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