Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study

Calabrese, Joseph R.; Jin, Na; Johnson, Brian R.; Such, Pedro; Baker, Ross A.; Madera, Jessica J; Hertel, P.; Ottinger, Jocelyn; Amatniek, Joan; Kawasaki, Hiroaki

doi:10.1186/s40345-018-0122-z

Cited by 15 publications

(13 citation statements)

References 26 publications

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“…The efficacy and safety of AOM 400, given every 4 weeks, as maintenance treatment of BP-I was investigated in two, 52-week studies, the full methodologic details of which have been previously published: A placebo-controlled, double-blind, randomized-withdrawal study (NCT01567527) conducted in 103 sites in 7 countries 7An open-label, multicenter study (NCT01710709) conducted in 149 sites in 10 countries 8…”

Section: Methodsmentioning

confidence: 99%

“…Both studies7,8 were conducted in compliance with the Declaration of Helsinki and International Conference on Harmonization Good Clinical Practice guidelines for conducting, recording and reporting trials, as well as for archiving essential documents. Consistent with ethical principles for the protection of human research subjects, no trial procedures were performed on trial candidates until written consent had been obtained from them.…”

Section: Methodsmentioning

confidence: 99%

“…Those meeting stability criteria (outpatient status, Young Mania Rating Scale [YMRS] total score ≤12, Montgomery–Asberg Depression Rating Scale [MADRS] total score ≤12 and no active suicidality) were randomized to double-blind treatment with AOM 400 or placebo for 52 weeks.

Figure 1Study design. ( A ) Randomized-withdrawal study (Calabrese et al, 2017)7, ( B ) open-label maintenance study (Calabrese et al, 2018a) 8 Abbreviation: AOM 400, Aripiprazole 400mg once-monthly.…”

Section: Methodsmentioning

confidence: 99%

“…Study design. ( A ) Randomized-withdrawal study (Calabrese et al, 2017)7, ( B ) open-label maintenance study (Calabrese et al, 2018a) 8…”

Section: Methodsmentioning

confidence: 99%

“…Aripiprazole 400 mg once monthly (AOM 400) is an LAI approved by the US Food and Drug Administration as maintenance monotherapy treatment for BP-I 6. Results from recent placebo-controlled7 and open-label8 studies show that maintenance treatment with AOM 400 delays the time to mood episode recurrence and is safe and well-tolerated.…”

Section: Introductionmentioning

confidence: 99%

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<p>Use of the Functioning Assessment Short Test (FAST) in defining functional recovery in bipolar I disorder. Post-hoc analyses of long-term studies of aripiprazole once monthly as maintenance treatment</p>

Madera¹,

Such²,

Zhang³

et al. 2019

NDT

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Purpose There is growing agreement that definitions of “recovery” in bipolar-I disorder (BP-I) should include functional outcomes beyond sustained symptomatic remission. In this post-hoc analysis, we assessed functional recovery rates according to the validated Functioning Assessment Short Test (FAST) in participants with BP-I after 52 weeks of maintenance treatment with aripiprazole once monthly (AOM). Patients and methods Rates of functional recovery with AOM 400 were investigated in two 52-week studies. NCT01567527 was a placebo-controlled, double-blind, randomized-withdrawal study and NCT01710709 was an open-label study. Functional recovery, assessed at the end of the respective maintenance phases, was defined as a total FAST score of ≤11 for 8 consecutive weeks. Results Post-hoc analyses included 229 patients from the randomized-withdrawal study (AOM 400 n=116; placebo n=113). The open-label study included 402 patients (including 321 de novo patients and 81 rollover patients who had completed the randomized-withdrawal study). In the randomized-withdrawal study, functional recovery was achieved by 30.2% (n=35) of the AOM 400 group compared with 24.8% (n=28) in the placebo group. The difference was not statistically significant ( p =0.39). In the open-label study, 36% (n=116) of de novo patients and 43% (n=35) of rollover patients had functionally recovered after 52 weeks of AOM 400 treatment. Conclusion These data highlight the utility of a sustained FAST total score of ≤11 as a definition of recovery and emphasize the possibility of achieving this ambitious treatment goal with effective long-term treatment.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

“…Study design. ( A ) Randomized-withdrawal study (Calabrese et al, 2017)7, ( B ) open-label maintenance study (Calabrese et al, 2018a) 8…”

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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<p>Use of the Functioning Assessment Short Test (FAST) in defining functional recovery in bipolar I disorder. Post-hoc analyses of long-term studies of aripiprazole once monthly as maintenance treatment</p>

Madera¹,

Such²,

Zhang³

et al. 2019

NDT

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Bipolar Disorder

2021

The Maudsley Prescribing Guidelines in Psychiatry

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This chapter provides expert guidance on mechanism of action of lithium, valproate, and carbamazepine as well as their formulations, indications, plasma levels, adverse effects, and prescribing for special patient groups. Calcium‐related genes have been implicated by genetic studies in bipolar disorder (BD). Clinical studies of the treatment of affective disorders variably use sodium valproate, semi‐sodium valproate, ‘valproate’ or valproic acid. Antipsychotics have been used in acute and maintenance treatment of BD since the 1960s, with evidence to suggest effectiveness at both poles of the illness, as well as mixed states. Oral paliperidone prevents manic relapse in BD and case reports describe good outcomes with the long‐acting injections form. Bipolar depression shares the same diagnostic criteria for a major depressive episode in major depressive disorder but episodes may differ in severity, time course, liability to recurrence and response to drug treatment.

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Preventive effect of aripiprazole once monthly on rehospitalization for bipolar disorder: A multicenter 1‐year retrospective mirror image study

Goto¹,

Shono²,

Abe³

et al. 2023

Neuropsychopharm Rep

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AimWe conducted a 1‐year retrospective mirror‐image study to investigate the effect of aripiprazole once monthly (AOM) on rehospitalization for bipolar disorder.MethodsParticipants were recruited from psychiatric emergency and acute care hospitals in western Japan. We included 39 participants with bipolar disorder who had been administered AOM for at least 1 year with no missing medical records during the observational period. The primary outcomes were rehospitalization rate, number of rehospitalizations, total hospitalization days, and time to rehospitalization in the context of overall psychiatric readmissions. The significance level was set at p < 0.05.ResultsAOM significantly reduced the rehospitalization rate from 23/39 (59%) to 7/39 (18%) (p = 0.001). The number of rehospitalizations decreased significantly from a mean of 0.85 per person‐year to 0.41 per person‐year (p = 0.048). The total hospitalization days significantly decreased from a mean of 34.9 days to 14.4 days (p = 0.008). AOM significantly prolonged the time to rehospitalization (p < 0.001).ConclusionThis study found that AOM reduces overall psychiatric rehospitalization for bipolar disorder based on data from 1 year before and after AOM administration in the real‐world setting. Future studies should examine the robustness and persistence of the rehospitalization preventive effect of AOM with larger sample sizes and longer observation periods beyond 1 year.

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Aripiprazole once-monthly as maintenance treatment for bipolar I disorder: a 52-week, multicenter, open-label study

Cited by 15 publications

References 26 publications

<p>Use of the Functioning Assessment Short Test (FAST) in defining functional recovery in bipolar I disorder. Post-hoc analyses of long-term studies of aripiprazole once monthly as maintenance treatment</p>

<p>Use of the Functioning Assessment Short Test (FAST) in defining functional recovery in bipolar I disorder. Post-hoc analyses of long-term studies of aripiprazole once monthly as maintenance treatment</p>

Bipolar Disorder

Preventive effect of aripiprazole once monthly on rehospitalization for bipolar disorder: A multicenter 1‐year retrospective mirror image study

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