Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder

Robert M Berman1, Michael E Thase2, Madhukar H Trivedi3, James A Hazel4, Sabrina Vogel Marler5, Robert D McQuade6, William Carson7, Ross A Baker8, Ronald N Marcus91Neuroscience Global Clinical Research Bristol-Myers Squibb, Wallingford, CT, USA; 2Department of Psychiatry, University of Pennsylvania...

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Autores principales:	Berman R, Thase M, Trivedi M, Hazel JA, Marler S, McQuade R, Carson W, Baker R, Marcus R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
Acceso en línea:	https://doaj.org/article/d53a80b7fbd44e37b9347a80c49e2718
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spelling	oai:doaj.org-article:d53a80b7fbd44e37b9347a80c49e27182021-12-02T02:16:36ZLong-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder1176-63281178-2021https://doaj.org/article/d53a80b7fbd44e37b9347a80c49e27182011-05-01T00:00:00Zhttp://www.dovepress.com/long-term-safety-and-tolerability-of-open-label-aripiprazole-augmentat-a7518https://doaj.org/toc/1176-6328https://doaj.org/toc/1178-2021Robert M Berman1, Michael E Thase2, Madhukar H Trivedi3, James A Hazel4, Sabrina Vogel Marler5, Robert D McQuade6, William Carson7, Ross A Baker8, Ronald N Marcus91Neuroscience Global Clinical Research Bristol-Myers Squibb, Wallingford, CT, USA; 2Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA; 3Division of Mood Disorders Research Program and Clinic, University of Texas Southwestern Medical School, Dallas, TX, USA; 4Neuroscience Global Clinical Research, Bristol-Myers Squibb, Wallingford, CT, USA; 5Global Biometric Sciences, Bristol-Myers Squibb, Wallingford, CT, USA; 6Global Medical Affairs at Otsuka Pharmaceutical Development &amp; Commercialization, Inc., Princeton, NJ, USA; 7Global Clinical Development, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, NJ, USA; 8Neuroscience Medical Strategy, Bristol-Myers Squibb Company, Plainsboro, NJ, USA; 9Neuroscience Global Clinical Research, Bristol-Myers Squibb, Wallingford, CT, USABackground: Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting.Patients and methods: Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received open-label aripiprazole for up to 52 weeks.Results: Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (&gt;15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced &ge;7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression-Severity of Illness score of 1 (not at all ill) or 2 (borderline ill).Conclusion: Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically.Keywords: adjunctive aripiprazole, antidepressant therapy, major depressive disorder, long-term safety and tolerabilityBerman RThase MTrivedi MHazel JAMarler SMcQuade RCarson WBaker RMarcus RDove Medical PressarticleNeurosciences. Biological psychiatry. NeuropsychiatryRC321-571Neurology. Diseases of the nervous systemRC346-429ENNeuropsychiatric Disease and Treatment, Vol 2011, Iss Issue 1, Pp 303-312 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429
spellingShingle	Neurosciences. Biological psychiatry. Neuropsychiatry RC321-571 Neurology. Diseases of the nervous system RC346-429 Berman R Thase M Trivedi M Hazel JA Marler S McQuade R Carson W Baker R Marcus R Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
description	Robert M Berman1, Michael E Thase2, Madhukar H Trivedi3, James A Hazel4, Sabrina Vogel Marler5, Robert D McQuade6, William Carson7, Ross A Baker8, Ronald N Marcus91Neuroscience Global Clinical Research Bristol-Myers Squibb, Wallingford, CT, USA; 2Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA, USA; 3Division of Mood Disorders Research Program and Clinic, University of Texas Southwestern Medical School, Dallas, TX, USA; 4Neuroscience Global Clinical Research, Bristol-Myers Squibb, Wallingford, CT, USA; 5Global Biometric Sciences, Bristol-Myers Squibb, Wallingford, CT, USA; 6Global Medical Affairs at Otsuka Pharmaceutical Development &amp; Commercialization, Inc., Princeton, NJ, USA; 7Global Clinical Development, Otsuka Pharmaceutical Development and Commercialization Inc, Princeton, NJ, USA; 8Neuroscience Medical Strategy, Bristol-Myers Squibb Company, Plainsboro, NJ, USA; 9Neuroscience Global Clinical Research, Bristol-Myers Squibb, Wallingford, CT, USABackground: Effective management of major depressive disorder often includes the long-term use of multiple medications, and the longer-term utility and safety of adjunctive aripiprazole has not been evaluated in a controlled setting.Patients and methods: Patients (n = 706) completing one of two 14-week double-blind studies of aripiprazole augmentation, as well as de novo patients (n = 296) nonresponsive to current antidepressant therapy, were enrolled in this open-label study. Patients received open-label aripiprazole for up to 52 weeks.Results: Open-label treatment was completed by 323 patients (32.2%). At endpoint (n = 987), the mean dose of aripiprazole was 10.1 mg/day. Common (&gt;15% of patients) spontaneously reported adverse events were akathisia (26.2%), fatigue (18.0%), and weight gain (17.1%). The incidence of serious adverse events was 4.0%. Four spontaneous reports of possible tardive dyskinesia were submitted (0.4%); all resolved within 45 days of drug discontinuation. Mean weight change was 4.4 kg; 36.6% experienced &ge;7% increase in weight from baseline (observed case analysis, n = 303). No clinically relevant changes in other metabolic parameters were seen. At the end of open-label treatment, 221 patients (69.7%) had a Clinical Global Impression-Severity of Illness score of 1 (not at all ill) or 2 (borderline ill).Conclusion: Long-term adjunctive aripiprazole therapy was well tolerated with an acceptable long-term safety and tolerability profile in patients with major depressive disorder who had not responded to treatment with one or more antidepressant therapies. Clinically significant weight gain was observed in about one-third of patients. Overall, the adverse event profile was consistent with that reported in the short-term trials and readily managed clinically.Keywords: adjunctive aripiprazole, antidepressant therapy, major depressive disorder, long-term safety and tolerability
format	article
author	Berman R Thase M Trivedi M Hazel JA Marler S McQuade R Carson W Baker R Marcus R
author_facet	Berman R Thase M Trivedi M Hazel JA Marler S McQuade R Carson W Baker R Marcus R
author_sort	Berman R
title	Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
title_short	Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
title_full	Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
title_fullStr	Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
title_full_unstemmed	Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
title_sort	long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/d53a80b7fbd44e37b9347a80c49e2718
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Long-term safety and tolerability of open-label aripiprazole augmentation of antidepressant therapy in major depressive disorder

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