Cariprazine in Acute Exacerbation of Schizophrenia

Durgam, Suresh; Cutler, Andrew J.; Lu, Kaifeng; Migliore, Raffaele; Ruth, Adam; Laszlovszky, István; Németh, György; Meltzer, Herbert Y.

doi:10.4088/jcp.15m09997

Cited by 144 publications

(92 citation statements)

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“…The efficacy and safety of cariprazine (dose ranges 1.5–9 mg/day) were evaluated in short-term, randomized, placebo- and active-controlled phase IIb (Durgam et al 2014) and phase III (Durgam et al 2015; Kane et al 2015) studies in patients with acute exacerbation of schizophrenia, as well as a double-blind, placebo-controlled relapse prevention study (Durgam et al 2016b). This single-arm, open-label extension study was conducted to evaluate the long-term safety and tolerability of cariprazine 1.5 to 4.5 mg/day in patients that had completed 6 weeks of double-blind treatment during a phase IIb, placebo- and active-controlled lead-in study of cariprazine in patients with acute exacerbation of schizophrenia (Durgam et al 2014).…”

Section: Introductionmentioning

confidence: 99%

Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study

Durgam

Greenberg

et al. 2016

Psychopharmacology

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RationaleCariprazine, a dopamine D3/D2 receptor partial agonist antipsychotic, demonstrated efficacy and tolerability in 6-week, randomized, placebo-controlled schizophrenia trials. Schizophrenia is a chronic disorder that requires continuous treatment; therefore, the long-term safety and tolerability profile of antipsychotic agents is an important factor in guiding clinician decisions.ObjectiveThis single-arm, open-label extension study evaluated the long-term safety and tolerability of cariprazine in patients with schizophrenia.MethodsPatients enrolled in this study completed a 6-week, randomized, placebo- and active-controlled study and had responded (Clinical Global Impressions-Severity [CGI-S] ≤3; ≥20 % reduction in Positive and Negative Syndrome Scale [PANSS] total score) to treatment at the end of the lead-in study. Patients (N = 93) received flexibly dosed, open-label cariprazine (1.5–4.5 mg/day) for up to 48 weeks.ResultsApproximately 50 % (46/93) of patients completed the 48 weeks of open-label treatment. The most common adverse events (AEs) were akathisia (14 %), insomnia (14 %), and weight increased (12 %). Serious AEs (SAEs) occurred in 13 % of patients; 11 % discontinued due to AEs. Mean changes in metabolic parameters were generally small and not clinically relevant. Mean body weight increased by 1.9 kg from the start of the lead-in study to the end of the extension study. There were no discontinuations associated with change in metabolic parameters or body weight. Long-term cariprazine treatment was not associated with prolactin elevation or clinically significant changes in cardiovascular parameters.ConclusionsIn this 48-week, single-arm trial, open-label cariprazine (1.5–4.5 mg/day) treatment was generally safe and well tolerated with no new safety concerns associated with long-term treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s00213-016-4450-3) contains supplementary material, which is available to authorized users.

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Section: Introductionmentioning

confidence: 99%

Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study

Durgam

Greenberg

et al. 2016

Psychopharmacology

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“…Across each cariprazine dose that was evaluated, mean CGI‐I scores at end‐point were between much improved (CGI‐I = 2) and minimally improved (CGI‐I = 3) and significantly different than placebo in the bipolar disorder studies at week 3 ( P < .001 each)6, 7, 8 and in the schizophrenia studies at week 6 ( P < .01 each) 9, 10, 11. Additionally, in a previous post hoc pooled analysis of data from the constituent bipolar disorder studies, the rate of CGI‐I response (score ≤ 2, much/very much improved) was significantly greater for cariprazine‐ (64%) vs placebo‐treated (42%) patients ( P < .0001),19 providing further support for our analyses.…”

Section: Discussionmentioning

confidence: 99%

“…RGH‐MD‐04 (NCT01104766)9 was a fixed‐dose study (cariprazine 3 mg/d or 6 mg/d); aripiprazole was included as an active control. RGH‐MD‐05 (NCT01104779)11 was a fixed/flexible‐dose study with 2 cariprazine treatment arms (3‐6 mg/d or 6‐9 mg/d).…”

Section: Methodsmentioning

confidence: 99%

“…Detailed methods of the included studies have been previously published 6, 7, 8, 9, 10, 11. Briefly, each study had a washout period of up to 1 week, followed by 3 weeks (bipolar mania studies) or 6 weeks (schizophrenia studies) of double‐blind treatment and a 2‐week safety follow‐up period.…”

Section: Methodsmentioning

confidence: 99%

“…Cariprazine has demonstrated efficacy in three 3‐week randomised, double‐blind, placebo‐controlled studies in bipolar mania6, 7, 8 and three 6‐week randomised, double‐blind, placebo‐ and active‐controlled studies in schizophrenia 9, 10, 11. In each of these studies, a significant difference vs placebo was seen in change from baseline on the primary efficacy measure (YMRS total score in the bipolar mania studies and PANSS total score in the schizophrenia studies); the CGI‐S was the secondary efficacy measure in each study.…”

Section: Introductionmentioning

confidence: 99%

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Global improvement with cariprazine in the treatment of bipolar I disorder and schizophrenia: A pooled post hoc analysis

Durgam

Earley

et al. 2017

Int J Clin Pract

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SummaryIntroductionGlobal rating scale measures are useful for assessing the clinical relevance of patient change. Cariprazine, a dopamine D3 and D2 receptor partial agonist, is FDA‐approved for the adult treatment of acute manic/mixed episodes of bipolar I disorder and schizophrenia. Post hoc evaluations of Clinical Global Impressions‐Severity (CGI‐S) scores from the cariprazine pivotal trials in both indications were conducted.MethodsData from 3 bipolar mania and 3 schizophrenia trials were pooled by indication (bipolar disorder = 1033; schizophrenia = 1466). Cariprazine‐ and placebo‐treated patients were categorised by baseline CGI‐S scores; the proportion of patients who improved from more severe categories at baseline to less severe categories at end‐point was evaluated using a logistic regression model. Correlations between Young Mania Rating Scale and Positive and Negative Syndrome Scale total score changes and category shifts were also evaluated.ResultsIn both disease states, more cariprazine‐ than placebo‐treated patients had improved CGI‐S scores at end‐point; more placebo‐treated patients had worse end‐point scores. More cariprazine‐ vs placebo‐treated patients shifted from the extremely/severely ill to mildly ill/better category (bipolar disorder = 55% vs 36%, odds ratio [OR] = 2.1; P = .09; schizophrenia = 42% vs 18%, OR = 3.4, P<.01). ORs was statistically significant in favour of cariprazine in shifts from marked and moderate illness to borderline/normal in both indications (P < .05). Correlations between rating scale improvement and category shift were greatest in patients with extreme/severe baseline illness for bipolar disorder (−0.853) and schizophrenia (−0.677).ConclusionsPost hoc analyses showed that more cariprazine‐ than placebo‐treated patients with bipolar mania or schizophrenia had statistically significant and clinically meaningful CGI‐S improvement.

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Evaluation of Differences in Individual Treatment Response in Schizophrenia Spectrum Disorders

et al. 2019

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Cariprazine in Acute Exacerbation of Schizophrenia

Abstract: ClinicalTrials.gov identifier: NCT01104766.

Cited by 144 publications

References 41 publications

Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study

Safety and tolerability of cariprazine in the long-term treatment of schizophrenia: results from a 48-week, single-arm, open-label extension study

Global improvement with cariprazine in the treatment of bipolar I disorder and schizophrenia: A pooled post hoc analysis

Evaluation of Differences in Individual Treatment Response in Schizophrenia Spectrum Disorders

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