Journal of affective disorders · 2025
The effect of adjunctive cariprazine on symptoms of anhedonia in patients with major depressive disorder.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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McIntyre Roger S, Maletic Vladimir, Masand Prakash, Wilson Andrea C, Yu Jun, Adams Julie L, Kerolous Majid
Аннотация
BACKGROUND: Anhedonia is a core diagnostic symptom of major depressive disorder (MDD). Post hoc analyses evaluated cariprazine plus antidepressant treatment (ADT) in patients with MDD and moderate-to-severe anhedonia.
METHODS: Data were analyzed from a positive phase 3, randomized, fixed-dose (1.5 or 3 mg/d), double-blind, placebo-controlled, parallel-group cariprazine study (NCT03738215). Post hoc outcomes (e.g., change from baseline to week 6 in MADRS total score, MADRS anhedonia subscale score, MADRS anhedonia subscale item scores including item 8 [inability to feel]) were assessed in 2 anhedonia patient subgroups (baseline MADRS anhedonia subscale score ≥ 18; baseline MADRS anhedonia item 8 score ≥ 4) using a mixed-effects model for repeated measures.
RESULTS: Most patients met subgroup inclusion criteria (anhedonia subscale score ≥ 18 = 584 [77.8 %]; anhedonia item 8 score ≥ 4 = 508 [67.6 %]). LSMDs in change from baseline were statistically significant in favor of adjunctive cariprazine versus adjunctive placebo in the MADRS anhedonia subscale score ≥ 18 subgroup (MADRS total score: 1.5 mg/d = -3.4, p = .0006; 3 mg/d = -2.1, p = .0358; anhedonia subscale score: 1.5 mg/d = -2.1, p = .0010; 3 mg/d = -1.26, p = .0399) and in the anhedonia item 8 score ≥ 4 subgroup for adjunctive cariprazine 1.5 mg/d (MADRS total score: -3.2, p = .0037; anhedonia subscale score: -1.9, p = .0066). Significant differences were seen for adjunctive cariprazine versus adjunctive placebo on several anhedonia subscale single items, including anhedonia item 8 for the 1.5 mg/d dose.
LIMITATION: Post hoc analysis.
CONCLUSION: In patients with MDD and moderate-to-severe anhedonia, adjunctive cariprazine improved symptoms of general depression and anhedonia, suggesting a potential benefit for patients with this clinically significant symptom.
METHODS: Data were analyzed from a positive phase 3, randomized, fixed-dose (1.5 or 3 mg/d), double-blind, placebo-controlled, parallel-group cariprazine study (NCT03738215). Post hoc outcomes (e.g., change from baseline to week 6 in MADRS total score, MADRS anhedonia subscale score, MADRS anhedonia subscale item scores including item 8 [inability to feel]) were assessed in 2 anhedonia patient subgroups (baseline MADRS anhedonia subscale score ≥ 18; baseline MADRS anhedonia item 8 score ≥ 4) using a mixed-effects model for repeated measures.
RESULTS: Most patients met subgroup inclusion criteria (anhedonia subscale score ≥ 18 = 584 [77.8 %]; anhedonia item 8 score ≥ 4 = 508 [67.6 %]). LSMDs in change from baseline were statistically significant in favor of adjunctive cariprazine versus adjunctive placebo in the MADRS anhedonia subscale score ≥ 18 subgroup (MADRS total score: 1.5 mg/d = -3.4, p = .0006; 3 mg/d = -2.1, p = .0358; anhedonia subscale score: 1.5 mg/d = -2.1, p = .0010; 3 mg/d = -1.26, p = .0399) and in the anhedonia item 8 score ≥ 4 subgroup for adjunctive cariprazine 1.5 mg/d (MADRS total score: -3.2, p = .0037; anhedonia subscale score: -1.9, p = .0066). Significant differences were seen for adjunctive cariprazine versus adjunctive placebo on several anhedonia subscale single items, including anhedonia item 8 for the 1.5 mg/d dose.
LIMITATION: Post hoc analysis.
CONCLUSION: In patients with MDD and moderate-to-severe anhedonia, adjunctive cariprazine improved symptoms of general depression and anhedonia, suggesting a potential benefit for patients with this clinically significant symptom.