Roger S. McIntyre, Pierre-Michel Llorca, Lauren C. Aronin, Jun Yu, Huy-Binh Nguyen
{"title":"卡利普嗪对躁狂症 I 型双相抑郁症患者的影响：三项随机安慰剂对照临床试验的事后分析。","authors":"Roger S. McIntyre, Pierre-Michel Llorca, Lauren C. Aronin, Jun Yu, Huy-Binh Nguyen","doi":"10.1007/s12325-024-03009-2","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p><h3>Methods</h3><p>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.</p><h3>Results</h3><p>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], <i>P</i> = .0024) and anhedonia factor scores (− 1.70 [− 2.77, − 0.62], <i>P</i> = .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], <i>P</i> = .0012; 3 mg/day = − 3.26 [− 5.12, − 1.40], <i>P</i> = .0006) and anhedonia factor scores (1.5 mg/day = − 1.97 [− 3.13, − 0.81], <i>P</i> = .0009; 3 mg/day = − 2.07 [− 3.26, − 0.89], <i>P</i> = .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.</p><h3>Conclusion</h3><p>Cariprazine demonstrated antidepressant and specific anti-anhedonic effects regardless of baseline anhedonia symptoms in patients with BP-I depression.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifiers, NCT02670538, NCT02670551, NCT01396447.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 1","pages":"246 - 260"},"PeriodicalIF":3.4000,"publicationDate":"2024-11-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11782341/pdf/","citationCount":"0","resultStr":"{\"title\":\"Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials\",\"authors\":\"Roger S. McIntyre, Pierre-Michel Llorca, Lauren C. Aronin, Jun Yu, Huy-Binh Nguyen\",\"doi\":\"10.1007/s12325-024-03009-2\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><p>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.</p><h3>Methods</h3><p>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.</p><h3>Results</h3><p>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], <i>P</i> = .0024) and anhedonia factor scores (− 1.70 [− 2.77, − 0.62], <i>P</i> = .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], <i>P</i> = .0012; 3 mg/day = − 3.26 [− 5.12, − 1.40], <i>P</i> = .0006) and anhedonia factor scores (1.5 mg/day = − 1.97 [− 3.13, − 0.81], <i>P</i> = .0009; 3 mg/day = − 2.07 [− 3.26, − 0.89], <i>P</i> = .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.</p><h3>Conclusion</h3><p>Cariprazine demonstrated antidepressant and specific anti-anhedonic effects regardless of baseline anhedonia symptoms in patients with BP-I depression.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifiers, NCT02670538, NCT02670551, NCT01396447.</p></div>\",\"PeriodicalId\":7482,\"journal\":{\"name\":\"Advances in Therapy\",\"volume\":\"42 1\",\"pages\":\"246 - 260\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2024-11-09\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11782341/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Advances in Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s12325-024-03009-2\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"MEDICINE, RESEARCH & EXPERIMENTAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Advances in Therapy","FirstCategoryId":"3","ListUrlMain":"https://link.springer.com/article/10.1007/s12325-024-03009-2","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
Effect of Cariprazine on Anhedonia in Patients with Bipolar I Depression: Post Hoc Analysis of Three Randomized Placebo-Controlled Clinical Trials
Introduction
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.
Methods
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.
Results
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.
Conclusion
Cariprazine demonstrated antidepressant and specific anti-anhedonic effects regardless of baseline anhedonia symptoms in patients with BP-I depression.
期刊介绍：
Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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