A Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Aripiprazole in Patients With Acute Bipolar Mania

Keck, Paul E.; Marcus, Ronald N.; Tourkodimitris, Stavros; Ali, Mirza; Liebeskind, Amy; Saha, A.; Ингенито, Г.

doi:10.1176/appi.ajp.160.9.1651

Cited by 429 publications

(275 citation statements)

References 31 publications

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“…21,22 In previous studies, aripiprazole was started at 30 mg/day, 6,7 whereas this study demonstrated the efficacy of aripiprazole with a treatment regimen starting at 15 mg/day. As 42% of aripiprazoletreated patients were on 15 mg/day at week 3, this study demonstrated that a treatment regimen with a starting dose of 15 mg/ day can be an effective approach for treating patients with acute bipolar mania.…”

Section: Discussionmentioning

confidence: 55%

Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

et al. 2009

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BackgroundWell-tolerated and effective therapies for bipolar mania are required.AimsTo evaluate the efficacy and tolerability of aripiprazole as acute and maintenance of effect therapy in patients with bipolar I disorder experiencing manic or mixed episodes.MethodPatients were randomised to double-blind aripiprazole (15 or 30 mg/day; n=167) placebo (n=153) or haloperidol (5–15 mg/day, n=165) for 3 weeks (trial registration NCT00097266). Aripiprazole- and haloperidol-treated patients remained on masked treatment for 9 additional weeks.ResultsMean change in Young Mania Rating Scale Total score (primary end-point) at week 3 was significantly greater with aripiprazole (–12.0; P<0.05) and haloperidol (–12.8; P<0.01) than with placebo (–9.7). Improvements were maintained to week 12 for aripiprazole (–17.2) and haloperidol (–17.8). Aripiprazole was well tolerated. Extrapyramidal adverse events were more frequent with haloperidol than aripiprazole (53.3% v. 23.5%).ConclusionsClinical improvements with aripiprazole were sustained to week 12. Aripiprazole was generally well tolerated.

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Section: Discussionmentioning

confidence: 55%

Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

et al. 2009

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“…This weight gain is in contrast to observations in studies with aripiprazole monotherapy in patients with schizophrenia, schizoaffective disorder, or bipolar disorder in which aripiprazole has been shown to have a low potential for weight gain. 16,[21][22][23][24][25][26][27][28][29] Furthermore, aripiprazole also demonstrated a low potential for weight gain when used as adjunctive treatment in patients with bipolar mania 29 or bipolar depression. 30 It is possible that concomitant prescription of aripiprazole with antidepressants may increase risk of weight gain.…”

Section: Discussionmentioning

confidence: 99%

Safety and Tolerability of Adjunctive Aripiprazole in Major Depressive Disorder

Nelson¹,

Thase²,

Trivedi³

et al. 2009

Prim. Care Companion J. Clin. Psychiatry

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Objective: To evaluate the safety and tolerability of aripiprazole adjunctive to standard antidepressant therapy (ADT) for patients with major depressive disorder (DSM-IV-TR criteria).Method: Data from 2 identical studies of aripiprazole augmentation (8 weeks of prospective ADT treatment followed by 6 weeks of randomized double-blind adjunctive treatment) were pooled. The incidence of treatmentemergent adverse events (TEAEs) and weight, electrocardiogram (ECG), and laboratory measurements were assessed during the 6-week phase, including time course, severity, resolution, and predictors. The studies were Results: The safety analysis included 737 outpatients (aripiprazole, n = 371; placebo, n = 366). The majority of patients completed the trials (aripiprazole, 86%; placebo, 88%). Common TEAEs (≥ 5% and twice the placebo rate) with aripiprazole were akathisia (25%), restlessness (12%), insomnia (8%), fatigue (8%), blurred vision (6%), and constipation (5%). Most TEAEs were of mild to moderate severity (aripiprazole, 89%; placebo, 95%). TEAE rates in the aripiprazole and placebo groups were not affected by ADT, age, or gender. Discontinuation due to TEAEs was low (aripiprazole, 3%; placebo, 1%). Mean weight change was higher with aripiprazole versus placebo (1.73 kg vs 0.38 kg, P < .001). At endpoint, clinical laboratory parameters, vital signs, and ECG indices (including QT c interval) were similar between groups. Akathisia with aripiprazole generally occurred in the first 3 weeks (76%), was of mild to moderate severity (92%), and led to discontinuation in 3 patients (0.8%). Within the aripiprazole group, age (18-40 years) was the only positive predictor for akathisia.Conclusions: In this short-term post hoc analysis, aripiprazole as augmentation to ADT demonstrated a safety and tolerability profile similar to that in monotherapy studies in other psychiatric populations. Controlled long-term safety and efficacy data of aripiprazole as adjunctive to ADT are warranted.

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“…Therefore, 20 articles were eligible for the current meta-analysis (Carlson et al, 2012;El-Mallakh et al, 2012;El Mallakh et al, 2010;Findling et al, 2013;Findling et al, 2009;Findling et al, 2012;Jeong et al, 2012;Kanba et al, 2014;Keck et al, 2007;Keck et al, 2003;Keck et al, 2009;Muzina et al, 2008;Quante et al, 2010;Sachs et al, 2006;Thase et al, 2008;Tramontina et al, 2009;Vieta et al, 2005;Vieta et al, 2008;Woo et al, 2011;Young et al, 2009) (Table 1). …”

Section: Study Selectionmentioning

confidence: 99%

“…One article (Keck et al, 2009) compared aripiprazole monotherapy and lithium in the acute phase of illness (aripiprazole = 155; lithium = 160), another article (El-Mallakh et al, 2012) compared aripiprazole monotherapy versus lithium in the maintenance stage (aripiprazole = 25; lithium = 38), and another article (Jeong et al, 2012) investigated the combination of aripiprazole with valproic acid versus haloperidol with valproic acid (aripiprazole = 28; haloperidol = 14). The remaining 15 articles (Carlson et al, 2012;El Mallakh et al, 2010;Findling et al, 2013;Findling et al, 2009;Findling et al, 2012;Kanba et al, 2014;Keck et al, 2007;Keck et al, 2003;Muzina et al, 2008;Quante et al, 2010;Sachs et al, 2006;Thase et al, 2008;Tramontina et al, 2009; A C C E P T E D M A N U S C R I P T …”

Section: Study Selectionmentioning

confidence: 99%

Efficacy, safety and tolerability of aripiprazole in bipolar disorder: An updated systematic review and meta-analysis of randomized controlled trials

Tseng²,

Stubbs

et al. 2017

Progress in Neuro-Psychopharmacology and Biological Psychiatry

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-keung Chow , Efficacy, safety and tolerability of aripiprazole in bipolar disorder: An updated systematic review and meta-analysis of randomized controlled trials. The address for the corresponding author was captured as affiliation for all authors. Please check if appropriate. Pnp(2017Pnp( ), doi: 10.1016Pnp( /j.pnpbp.2017 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.A C C E P T E D M A N U S C R I P T Aripiprazole was associated with lower relapse rates in bipolar mania when used in combination versus a placebo in maintenance therapy (odds ratio: 0.522, p<0.029). ACCEPTED MANUSCRIPT A C C E P T E D M A N U S C R I P TAripiprazole was also associated with higher levels of high density lipoprotein, lower dropout rates, but no difference in extrapyramidal symptoms in the maintenance phase versus a placebo or in comparison with other medications (haloperidol or lithium). Our results suggest that aripiprazole is effective and safe in treating bipolar mania. Further trials are necessary to evaluate the efficacy and tolerability versus other medications.

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A Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Aripiprazole in Patients With Acute Bipolar Mania

Abstract: Aripiprazole had significantly greater efficacy than placebo for the treatment of bipolar disorder patients in acute manic or mixed episodes and was safe and well tolerated in this randomized controlled trial.

Cited by 429 publications

References 31 publications

Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

Aripiprazole monotherapy in acute mania: 12-week randomised placebo- and haloperidol-controlled study

Safety and Tolerability of Adjunctive Aripiprazole in Major Depressive Disorder

Efficacy, safety and tolerability of aripiprazole in bipolar disorder: An updated systematic review and meta-analysis of randomized controlled trials

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