| The efficacy and safety of aripiprazole as adjunctive therapy in major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled study. | |
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MedLine Citation:
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PMID: 17592907 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVE: To assess the efficacy and safety of aripiprazole versus placebo as adjunctive treatment to standard antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who showed an incomplete response to 1 prospective and 1 to 3 historical courses of ADT within the current episode. METHOD: The study comprised a 7- to 28-day screening phase, an 8-week prospective treatment phase, and a 6-week double-blind treatment phase. Patients with DSM-IV-TR-defined MDD were enrolled between June 16, 2004, and April 27, 2006. During prospective treatment, patients received ADT: escitalopram, fluoxetine, paroxetine controlled-release, sertraline, or venlafaxine extended-release, each with single-blind, adjunctive placebo. Incomplete responders continued ADT and were randomly assigned to double-blind, adjunctive placebo or adjunctive aripiprazole (2-15 mg/day with fluoxetine or paroxetine; 2-20 mg/day with all others). The primary efficacy endpoint was the mean change from end of prospective treatment to end of double-blind treatment (week 14, last observation carried forward) in Montgomery-Asberg Depression Rating Scale (MADRS) total score (analysis of covariance). RESULTS: A total of 178 patients were randomly assigned to adjunctive placebo and 184 to adjunctive aripiprazole. Baseline demographics were similar between groups (mean MADRS total score of 26.0). Mean change in MADRS total score was significantly greater with adjunctive aripiprazole (-8.8) than adjunctive placebo (-5.8; p < .001). Adverse events (AEs) that occurred in > or = 10% of patients with adjunctive placebo or adjunctive aripiprazole were akathisia (4.5% vs. 23.1%), headache (10.8% vs. 6.0%), and restlessness (3.4% vs. 14.3%). Discontinuations due to AEs were low with adjunctive placebo (1.7%) and adjunctive aripiprazole (2.2%); only 1 adjunctive aripiprazole-treated patient discontinued due to akathisia. CONCLUSIONS: In patients with MDD who showed an incomplete response to ADT, adjunctive aripiprazole was efficacious and well tolerated. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov identifier NCT00095823. |
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Authors:
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Robert M Berman; Ronald N Marcus; René Swanink; Robert D McQuade; William H Carson; Patricia K Corey-Lisle; Arif Khan |
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Publication Detail:
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Type: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: The Journal of clinical psychiatry Volume: 68 ISSN: 1555-2101 ISO Abbreviation: J Clin Psychiatry Publication Date: 2007 Jun |
Date Detail:
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Created Date: 2007-06-26 Completed Date: 2007-07-19 Revised Date: 2008-09-04 |
Medline Journal Info:
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Nlm Unique ID: 7801243 Medline TA: J Clin Psychiatry Country: United States |
Other Details:
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Languages: eng Pagination: 843-53 Citation Subset: IM |
Affiliation:
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Bristol-Myers Squibb Co., Wallingford, Conn. 06492, USA. Robert.Berman@bms.com |
| Data Bank Information | |
Bank Name/Acc. No.:
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ClinicalTrials.gov/NCT00095823 |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Antidepressive Agents / therapeutic use* Antipsychotic Agents / adverse effects, therapeutic use* Depressive Disorder, Major / drug therapy* Double-Blind Method Drug Therapy, Combination Female Humans Male Middle Aged Piperazines / adverse effects, therapeutic use* Quinolones / adverse effects, therapeutic use* Severity of Illness Index Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Antidepressive Agents; 0/Antipsychotic Agents; 0/Piperazines; 0/Quinolones; 129722-12-9/aripiprazole |
| Comments/Corrections | |
Comment In:
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J Clin Psychiatry. 2008 Jun;69(6):1021; author reply 1021-2
[PMID:
18684004
]
Evid Based Ment Health. 2008 Feb;11(1):15 [PMID: 18223050 ] |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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