Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia

Naber, Dieter; Hansen, Karina; Forray, Carlos; Baker, Ross A.; Sapin, Christophe; Beillat, Maud; Peters-Strickland, Timothy; Nylander, Anna‐Greta; Hertel, P.; Andersen, Hans Skifter; Eramo, Anna; Loze, Jean‐Yves; Potkin, Steven G.

doi:10.1016/j.schres.2015.07.007

Cited by 134 publications

(166 citation statements)

References 23 publications

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“…Aripiprazole once-monthly 400 mg (AOM 400), an LAI formulation of aripiprazole, has demonstrated efficacy in schizophrenia in multiple randomized clinical studies. [26][27][28][29] Findings from these studies, the established efficacy of oral aripiprazole in BP-I, and the potential for improved adherence formed the basis for evaluating AOM 400 as maintenance treatment of BP-I.…”

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confidence: 99%

Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder

Calabrese

Sanchez

Jin

et al. 2017

J. Clin. Psychiatry

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115

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Objective: To evaluate efficacy, safety, and tolerability of longacting injectable antipsychotic aripiprazole once-monthly 400 mg (AOM 400) as maintenance treatment for bipolar I disorder (BP-I). Methods: In a double-blind, placebo-controlled, 52-week randomized withdrawal study conducted from August 2012 to April 2016, patients with a DSM-IV-TR diagnosis of BP-I currently experiencing a manic episode were stabilized sequentially on oral aripiprazole and AOM 400 and then randomized to AOM 400 or placebo. The primary end point was time from randomization to recurrence of any mood episode. Other end points included proportion of patients with recurrence of any mood episode and recurrence by mood episode type. Results: Of 266 randomized patients, 64 (48.1%) of 133 in the AOM 400 group and 38 (28.6%) of 133 in the placebo group completed the study. AOM 400 significantly delayed the time to recurrence of any mood episode compared with placebo (hazard ratio: 0.45; 95% CI, 0.30 to 0.68; P < .0001). Significantly fewer patients (P < .0001) experienced recurrence of any mood episode with AOM 400 (35/132; 26.5%) compared with placebo (68/133; 51.1%), with the effects observed predominantly on manic episodes (P < .0001). Patients were not depressed at study entry, and between-group differences in depressive episodes were not significant (P < .864). The treatment-emergent adverse events (incidence > 5%) that were reported at higher rates with AOM 400 than placebo were weight increase, akathisia, insomnia, and anxiety. Conclusions: AOM 400 delayed the time to and reduced the rate of recurrence of mood episodes and was generally safe and well tolerated. These findings support the use of AOM 400 for maintenance treatment of BP-I. Trial Registration: ClinicalTrials.gov identifier: NCT01567527 Clin Psychiatry 2017;78(3):324-331 https://doi.org/10.4088/JCP.16m11201 J

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confidence: 99%

Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder

Calabrese

Sanchez

Jin

et al. 2017

J. Clin. Psychiatry

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115

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“…They also simplify compliance monitoring, as non-compliance is quickly recognized, if patients do not show up for scheduled injections [52]. Several NGAs, including risperidone LAI, paliperidone palmitate, olanzapine pamoate, and LAI [56]. Moreover, AOM 400 showed a more favorable tolerability profile compared with PP.…”

Section: ) Im Depot Antipsychoticsmentioning

confidence: 99%

Pharmacological Treatment of Schizophrenia:

Fleischhacker

Miyamoto

2016

CNPT

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In the past decade, four main topics have shaped research and clinical practice. 1) In randomized controlled trials, researchers have investigated whether treating prodromal symptoms of schizophrenia helps to reduce the conversion risk to full-blown schizophrenia. Results are ambiguous and the discussion on whether or not an intervention at the stage is justified is ongoing. 2) Following the enhanced understanding of the pathophysiology of schizophrenia, also with respect to specific symptom domains, pharmacological targets beyond D 2 receptor antagonism have been explored. Much work and enthusiasm has revolved around nicotinergic and glutamatergic compounds, so far with mostly discouraging results. 3) Several new-generation antipsychotics have become available as long-acting formulations. All of them have demonstrated a significant positive impact on relapse rates in placebo controlled studies. Whether these compounds also have advantages over first-generation depots and/or oral antipsychotics is still debated. The development of an inhalable antipsychotic has complemented the treatment options for the management of acutely agitated patients. 4) Lastly, attempts from various perspectives, including genetics and neuroimaging, have investigated whether it is possible to predict treatment response and drug safety. Although some look promising, they have not yet reached a stage in which they can be applied to everyday clinical practice. What has become clear, though, is that early non response predicts late non response, leading to the recommendation to switch antipsychotics much earlier than stated in most treatment guidelines.

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“…However, a double-blind, randomized study (Neuroleptic Strategy Study) evaluating subjective QoL as the primary outcome measure with the Short-Form 36 Health Survey coupled with the Clinical Global Impression-Improvement scale found significantly greater improvement with SGAs compared with FGAs [14]. Finally, a recent, randomized, rater-blinded, open-label, non-inferiority study comparing two SGAs (both LAIs, thus adherence was controlled for) on a primary outcome measure of objective QoL using the QLS was conducted [15]. A small (though significant) difference between the two agents was found, and younger patients (≤35 years) compared with older patients (>35 years) responded significantly better on QoL as well as on other measures of efficacy and functionality.…”

Section: The Role Of Second-generation Antipsychoticsmentioning

confidence: 99%

How can the new antipsychotic medications improve quality of life in patients with schizophrenia?

Chue

2016

Expert Opinion on Pharmacotherapy

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Qualify: a randomized head-to-head study of aripiprazole once-monthly and paliperidone palmitate in the treatment of schizophrenia

Abstract: Superior improvements on clinician-rated health-related quality of life and a favorable tolerability profile suggest greater overall effectiveness for aripiprazole once-monthly vs paliperidone palmitate. ClinicalTrials.gov identifier:NCT01795547.

Cited by 134 publications

References 23 publications

Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder

Efficacy and Safety of Aripiprazole Once-Monthly in the Maintenance Treatment of Bipolar I Disorder

Pharmacological Treatment of Schizophrenia:

How can the new antipsychotic medications improve quality of life in patients with schizophrenia?

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