A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar I disorder (the AMAZE study)

Kanba, Shigenobu; Kawasaki, Hiroaki; Ishigooka, Jun; Sakamoto, Kaoru; Kinoshita, Toshihiko; Kuroki, Tetsuo

doi:10.3109/15622975.2012.669047

Cited by 29 publications

(17 citation statements)

References 28 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…There are 5 positive (Keck et al, 2003b, 2009; Sachs et al, 2006; Young et al, 2009; Kanba et al, 2014) and one negative fixed dosage study (El Mallakh et al, 2010) concerning the efficacy of aripiprazole 15 to 30 mg/d for the treatment of acute manic and mixed episodes. One study was not completed and reported no results.…”

Section: Efficacy Datamentioning

confidence: 99%

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 2: Review, Grading of the Evidence, and a Precise Algorithm

Fountoulakis

Yatham

Grunze

et al. 2016

IJNPPY

View full text Add to dashboard Cite

Background:The current paper includes a systematic search of the literature, a detailed presentation of the results, and a grading of treatment options in terms of efficacy and tolerability/safety.Material and Methods:The PRISMA method was used in the literature search with the combination of the words ‘bipolar,’ ‘manic,’ ‘mania,’ ‘manic depression,’ and ‘manic depressive’ with ‘randomized,’ and ‘algorithms’ with ‘mania,’ ‘manic,’ ‘bipolar,’ ‘manic-depressive,’ or ‘manic depression.’ Relevant web pages and review articles were also reviewed.Results:The current report is based on the analysis of 57 guideline papers and 531 published papers related to RCTs, reviews, posthoc, or meta-analysis papers to March 25, 2016. The specific treatment options for acute mania, mixed episodes, acute bipolar depression, maintenance phase, psychotic and mixed features, anxiety, and rapid cycling were evaluated with regards to efficacy. Existing treatment guidelines were also reviewed. Finally, Tables reflecting efficacy and recommendation levels were created that led to the development of a precise algorithm that still has to prove its feasibility in everyday clinical practice.Conclusions:A systematic literature search was conducted on the pharmacological treatment of bipolar disorder to identify all relevant random controlled trials pertaining to all aspects of bipolar disorder and graded the data according to a predetermined method to develop a precise treatment algorithm for management of various phases of bipolar disorder. It is important to note that the some of the recommendations in the treatment algorithm were based on the secondary outcome data from posthoc analyses.

show abstract

Section: Efficacy Datamentioning

confidence: 99%

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 2: Review, Grading of the Evidence, and a Precise Algorithm

Fountoulakis

Yatham

Grunze

et al. 2016

IJNPPY

View full text Add to dashboard Cite

show abstract

“…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%

“…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%

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

View full text Add to dashboard Cite

-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.

show abstract

“…Both the FDA guidelines and those of the EMA allow the use of the drug in these conditions from 15 to 30 mg/day, but they recommend doses of 15 mg. The only study that used a fixed dose of 15 mg of ARI [23] showed no efficacy compared to PCB. Thus clinicians must consider the possibility of using ARI at a high dose in the allowed range but also that the risk of EPS is dose-dependent [55].…”

Section: Expert Opinionmentioning

confidence: 83%

“…5.1 Treatment of acute manic or mixed episodes We found six RCTs versus placebo (PCB) on efficacy of oral ARI in the treatment of acute mania and mixed states in adults with BD type-1 (DSM-IV) [23][24][25][26][27][28]. These trials have in common the inclusion of people with ‡ 18 years old, the duration of 3 weeks and the primary outcome (mean change in the Young Mania Rating Scale [YMRS] at the end measured with the Last Observation Carried Forward [LOCF] dataset).…”

Section: Clinical Efficacy and Safetymentioning

confidence: 99%

Evaluating aripiprazole as a potential bipolar disorder therapy for adults

Moro

Carta

2014

Expert Opinion on Investigational Drugs

View full text Add to dashboard Cite

Compared with haloperidol, ARI shows fewer extrapyramidal symptoms (EPS), but has a slightly lower efficacy in mania. It has a better metabolic parameter profile and fewer cardiovascular adverse events than other SGAs although the add-on treatment shows a higher risk of EPS. Presently, data doesn't support its use as a first choice maintenance monotherapy but it may be useful as a combination therapy for BD patients with comorbidities such as drug abuse and obsessive-compulsive disorders. Studies on ARI in bipolar depression are disappointing. However, future studies on the drug, at a low dose combined with a stabilizer or antidepressant may prove interesting.

show abstract

A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole for the treatment of acute manic or mixed episodes in Asian patients with bipolar I disorder (the AMAZE study)

Abstract: Aripiprazole had significantly greater efficacy than placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder in Asian patients. Treatment was generally safe and well tolerated.

Cited by 29 publications

References 28 publications

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 2: Review, Grading of the Evidence, and a Precise Algorithm

The International College of Neuro-Psychopharmacology (CINP) Treatment Guidelines for Bipolar Disorder in Adults (CINP-BD-2017), Part 2: Review, Grading of the Evidence, and a Precise Algorithm

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

Evaluating aripiprazole as a potential bipolar disorder therapy for adults

Contact Info

Product

Resources

About