Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials
Notice bibliographique
Résumé
Anhedonic symptoms in bipolar I (BP-I) depression are associated with decreased quality of life and impaired functioning. We evaluated the effects of cariprazine in patients with BP-I depression with lower or higher levels of anhedonia at baseline. Data were pooled from three clinical trials (NCT01396447, NCT02670538, NCT02670551) analyzing the effects of cariprazine 1.5 and 3 mg/day in adults with BP-I depression. During post hoc analysis, patients were stratified by baseline median Montgomery-Åsberg Depression Rating Scale (MADRS) anhedonia factor score into a lower (score < median) or higher (score ≥ median) anhedonia subgroup. Outcomes included change from baseline to week 6 in MADRS total and anhedonia factor score, with the latter also evaluated after adjusting for other depressive symptoms. Between-group differences in change from baseline to week 6 were compared using least-squares mean differences (LSMD) analyzed via a mixed-effect model for repeated measures. Median baseline anhedonia factor score was 19, defining the lower (placebo = 211; cariprazine 1.5 mg/day = 200, 3 mg/day = 212) and higher (placebo = 249; cariprazine 1.5 mg/day = 261, 3 mg/day = 250) anhedonia subgroups. In the lower subgroup, cariprazine 1.5 mg/day but not 3 mg/day was superior to placebo in reducing MADRS total (LSMD [95% CI] 1.5 mg/day = − 2.61 [− 4.28, − 0.93], P = .0024) and anhedonia factor scores (− 1.70 [− 2.77, − 0.62], P = .0021) at week 6. In the higher subgroup, both cariprazine doses were associated with significantly greater reductions than placebo in MADRS total (1.5 mg/day = − 3.01 [− 4.84, − 1.19], P = .0012; 3 mg/day = − 3.26 [− 5.12, − 1.40], P = .0006) and anhedonia factor scores (1.5 mg/day = − 1.97 [− 3.13, − 0.81], P = .0009; 3 mg/day = − 2.07 [− 3.26, − 0.89], P = .0006). Anti-anhedonic effects were preserved after adjusting for other depressive symptoms, suggesting the effect was not pseudospecific. Patients in the higher subgroup had higher baseline depression and therefore the lower subgroup may have had a floor effect. Cariprazine demonstrated antidepressant and specific anti-anhedonic effects regardless of baseline anhedonia symptoms in patients with BP-I depression. ClinicalTrials.gov identifiers, NCT02670538, NCT02670551, NCT01396447. Anhedonia, or the lack of interest or pleasure, is common in patients with bipolar I depression. Cariprazine is a medication approved for the treatment of bipolar I depression. However, its effect on anhedonia is unclear. To understand the effect of cariprazine on anhedonia, we combined data from three bipolar I depression trials. We compared the effect of cariprazine treatment (1.5 mg or 3 mg per day) for 6 weeks against placebo in patients who had lower and higher levels of anhedonia before they started treatment. A total of 1383 patients were included in the study. There were 623 patients with lower anhedonia and 760 with higher anhedonia. Patients with higher anhedonia were more depressed overall than those with lower anhedonia. In patients with lower anhedonia, cariprazine 1.5 mg per day was better than placebo at reducing both anhedonia and depression. In patients with higher anhedonia, both cariprazine doses were better than placebo at reducing anhedonia and depression. Our results suggest that cariprazine reduces symptoms of both depression and anhedonia in patients with bipolar I depression.
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Comment cette classification a été obtenuedéplier
Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,006 | 0,002 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,004 | 0,001 |
| Bibliométrie | 0,001 | 0,001 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».