Efficacy of Adjunctive Aripiprazole to Either Valproate or Lithium in Bipolar Mania Patients Partially Nonresponsive to Valproate/Lithium Monotherapy: A Placebo-Controlled Study

Vieta, Eduard; T'joen, Caroline; McQuade, Robert D.; Carson, William H.; Marcus, Ronald N.; Sanchez, Raymond; Owen, Randall; Nameche, Laurence

doi:10.1176/appi.ajp.2008.07101560

Cited by 143 publications

(100 citation statements)

References 23 publications

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“…As previously reported, a six-week, placebo-controlled RCT showed that adding aripiprazole to lithium or divalproex in 384 patients with an inadequate response was significantly more effective than placebo from week 1 onward (60). A 46-week open-label extension of this study found that aripiprazole as an adjunct to lithium or divalproex provided continued improvement in mania but not depression (61).…”

Section: Pharmacological Treatment Of Manic Episodessupporting

confidence: 71%

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013

et al. 2012

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Yatham LN, Kennedy SH, Parikh SV, Schaffer A, Beaulieu S, Alda M, O’Donovan C, MacQueen G, McIntyre RS, Sharma V, Ravindran A, Young LT, Milev R, Bond DJ, Frey BN, Goldstein BI, Lafer B, Birmaher B, Ha K, Nolen WA, Berk M.  Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013.  Bipolar Disord 2012: 00: 000–000. © 2012 John Wiley & Sons A/S.Published by Blackwell Publishing Ltd.The Canadian Network for Mood and Anxiety Treatments published guidelines for the management of bipolar disorder in 2005, with updates in 2007 and 2009. This third update, in conjunction with the International Society for Bipolar Disorders, reviews new evidence and is designed to be used in conjunction with the previous publications.The recommendations for the management of acute mania remain largely unchanged. Lithium, valproate, and several atypical antipsychotic agents continue to be first‐line treatments for acute mania. Monotherapy with asenapine, paliperidone extended release (ER), and divalproex ER, as well as adjunctive asenapine, have been added as first‐line options.For the management of bipolar depression, lithium, lamotrigine, and quetiapine monotherapy, as well as olanzapine plus selective serotonin reuptake inhibitor (SSRI), and lithium or divalproex plus SSRI/bupropion remain first‐line options. Lurasidone monotherapy and the combination of lurasidone or lamotrigine plus lithium or divalproex have been added as a second‐line options. Ziprasidone alone or as adjunctive therapy, and adjunctive levetiracetam have been added as not‐recommended options for the treatment of bipolar depression. Lithium, lamotrigine, valproate, olanzapine, quetiapine, aripiprazole, risperidone long‐acting injection, and adjunctive ziprasidone continue to be first‐line options for maintenance treatment of bipolar disorder. Asenapine alone or as adjunctive therapy have been added as third‐line options.

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Section: Pharmacological Treatment Of Manic Episodessupporting

confidence: 71%

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013

et al. 2012

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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%

“…Only two articles compared aripiprazole in combination therapy in the acute phase of BD thus precluding meta-analysis (Quante et al, 2010;Vieta et al, 2008).…”

Section: Primary Outcome: Relapse Rates For Maniamentioning

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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Efficacy of Adjunctive Aripiprazole to Either Valproate or Lithium in Bipolar Mania Patients Partially Nonresponsive to Valproate/Lithium Monotherapy: A Placebo-Controlled Study

Abstract: Adjunctive aripiprazole therapy showed significant improvements in mania symptoms as early as week 1 and demonstrated a tolerability profile similar to that of monotherapy studies.

Cited by 143 publications

References 23 publications

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) collaborative update of CANMAT guidelines for the management of patients with bipolar disorder: update 2013

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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