Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol

Ab, Smulevich; Khanna, Sumant; Eerdekens, Mariëlle; Karcher, Keith; Kramer, Michelle; Grossman, Fred

doi:10.1016/j.euroneuro.2004.06.003

Cited by 151 publications

(151 citation statements)

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“…[26][27][28] Importantly, response and remission rates were comparable between aripiprazole and haloperidol at week 3 and showed continued improvement to week 12; at week 12, nearly 75% of patients had responded to treatment and the majority of patients had reached remission. Response rates reported here with aripiprazole at week 3 are similar to those seen in similar trials with risperidone (risperidone 48% v. placebo 33%) 26 and quetiapine (quetiapine 43% v. placebo 35%), although response rates for haloperidol in this second study were higher (56%). 25 Furthermore, although completion rates reported here were similar between treatment arms at week 3, similar completion rates between treatment arms have also been observed in previous studies of this design with risperidone (risperidone 89%; placebo 85%; haloperidol 90%).…”

Section: Discussionmentioning

confidence: 80%

“…25 Furthermore, although completion rates reported here were similar between treatment arms at week 3, similar completion rates between treatment arms have also been observed in previous studies of this design with risperidone (risperidone 89%; placebo 85%; haloperidol 90%). 26 There was a low rate of emergent depression over the 12-week study for both aripiprazole-and haloperidol-treated patients. Furthermore, MADRS scores, although low at baseline, showed no worsening of depressive symptoms with either treatment at week 3 and week 12, suggesting that improvement in mania was not associated with a worsening of depression in patients with mania.…”

Section: Discussionmentioning

confidence: 99%

“…Although the lack of a placebo comparator arm beyond the first 3 weeks of study could be considered a limitation, use of placebo for only 3 weeks is an accepted methodology and a previous study with risperidone used a similar design. 26 Furthermore, there are many ethical arguments against the use of placebo beyond the acute treatment phase in patients with bipolar disorder. 27 In conclusion, aripiprazole significantly improved symptoms during the 3-week placebo-controlled phase of the study in patients with acute mania.…”

Section: Tolerabilitymentioning

confidence: 99%

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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: 80%

Section: Discussionmentioning

confidence: 99%

Section: Tolerabilitymentioning

confidence: 99%

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

et al. 2009

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“…There is no evidence of superiority of any first‐line monotherapy treatment in comparison to other monotherapy options in treating patients with psychotic features. Similarly, there is no evidence that any first‐line combination therapy of lithium or divalproex plus an atypical antipsychotic is more effective than other first‐line combination therapy 174, 193, 213, 214. However, clinical experience suggests that the combination of lithium or divalproex plus an atypical antipsychotic is more appropriate for manic patients with mood‐incongruent psychotic features (ie, other than grandiose delusions).…”

Section: Acute Management Of Bipolar Maniamentioning

confidence: 99%

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

et al. 2018

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The Canadian Network for Mood and Anxiety Treatments (CANMAT) previously published treatment guidelines for bipolar disorder in 2005, along with international commentaries and subsequent updates in 2007, 2009, and 2013. The last two updates were published in collaboration with the International Society for Bipolar Disorders (ISBD). These 2018 CANMAT and ISBD Bipolar Treatment Guidelines represent the significant advances in the field since the last full edition was published in 2005, including updates to diagnosis and management as well as new research into pharmacological and psychological treatments. These advances have been translated into clear and easy to use recommendations for first, second, and third‐ line treatments, with consideration given to levels of evidence for efficacy, clinical support based on experience, and consensus ratings of safety, tolerability, and treatment‐emergent switch risk. New to these guidelines, hierarchical rankings were created for first and second‐ line treatments recommended for acute mania, acute depression, and maintenance treatment in bipolar I disorder. Created by considering the impact of each treatment across all phases of illness, this hierarchy will further assist clinicians in making evidence‐based treatment decisions. Lithium, quetiapine, divalproex, asenapine, aripiprazole, paliperidone, risperidone, and cariprazine alone or in combination are recommended as first‐line treatments for acute mania. First‐line options for bipolar I depression include quetiapine, lurasidone plus lithium or divalproex, lithium, lamotrigine, lurasidone, or adjunctive lamotrigine. While medications that have been shown to be effective for the acute phase should generally be continued for the maintenance phase in bipolar I disorder, there are some exceptions (such as with antidepressants); and available data suggest that lithium, quetiapine, divalproex, lamotrigine, asenapine, and aripiprazole monotherapy or combination treatments should be considered first‐line for those initiating or switching treatment during the maintenance phase. In addition to addressing issues in bipolar I disorder, these guidelines also provide an overview of, and recommendations for, clinical management of bipolar II disorder, as well as advice on specific populations, such as women at various stages of the reproductive cycle, children and adolescents, and older adults. There are also discussions on the impact of specific psychiatric and medical comorbidities such as substance use, anxiety, and metabolic disorders. Finally, an overview of issues related to safety and monitoring is provided. The CANMAT and ISBD groups hope that these guidelines become a valuable tool for practitioners across the globe.

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“…Placeboassociated improvement in mean mania ratings relative to baseline varied greatly, from À19% (Zarate et al, 2007) or + 0.63% (Pope et al, 1991) to + 38% (McIntyre et al, 2009a). Likewise, study drop-out rates ranged from 13-15% (Kushner et al, 2006;Smulevich et al, 2005, respectively) to 82% (Hirschfeld et al, 2010) with placebo, and from 11-14% (Bowden et al, 2005;Khanna et al, 2005;Smulevich et al, 2005) to 83% (Hirschfeld et al, 2010) with drug. The impact of these sources of variance lie beyond this study and are reported separately (Yildiz et al, 2010).…”

Section: Characteristics Of Trials and Subjectsmentioning

confidence: 99%

Efficacy of Antimanic Treatments: Meta-analysis of Randomized, Controlled Trials

Yıldız

Vieta

Leucht

et al. 2010

Neuropsychopharmacol

222

172

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We conducted meta-analyses of findings from randomized, placebo-controlled, short-term trials for acute mania in manic or mixed states of DSM (III-IV) bipolar I disorder in 56 drug-placebo comparisons of 17 agents from 38 studies involving 10 800 patients. Of drugs tested, 13 (76%) were more effective than placebo: aripiprazole, asenapine, carbamazepine, cariprazine, haloperidol, lithium, olanzapine, paliperdone, quetiapine, risperidone, tamoxifen, valproate, and ziprasidone. Their pooled effect size for mania improvement (Hedges' g in 48 trials) was 0.42 (confidence interval (CI): 0.36-0.48); pooled responder risk ratio (46 trials) was 1.52 (CI: 1.42-1.62); responder rate difference (RD) was 17% (drug: 48%, placebo: 31%), yielding an estimated number-needed-to-treat of 6 (all po0.0001). In several direct comparisons, responses to various antipsychotics were somewhat greater or more rapid than lithium, valproate, or carbamazepine; lithium did not differ from valproate, nor did second generation antipsychotics differ from haloperidol. Meta-regression associated higher study site counts, as well as subject number with greater placebo (not drug) response; and higher baseline mania score with greater drug (not placebo) response. Most effective agents had moderate effect-sizes (Hedges' g ¼ 0.26-0.46); limited data indicated large effect sizes (Hedges' g ¼ 0.51-2.32) for: carbamazepine, cariprazine, haloperidol, risperidone, and tamoxifen. The findings support the efficacy of most clinically used antimanic treatments, but encourage more head-to-head studies and development of agents with even greater efficacy.

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Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol

Cited by 151 publications

References 33 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

Canadian Network for Mood and Anxiety Treatments (CANMAT) and International Society for Bipolar Disorders (ISBD) 2018 guidelines for the management of patients with bipolar disorder

Efficacy of Antimanic Treatments: Meta-analysis of Randomized, Controlled Trials

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