An evaluation of the safety and efficacy of cariprazine in patients with acute exacerbation of schizophrenia: A phase II, randomized clinical trial

Durgam, Suresh; Starace, Anju; Li, Dayong; Migliore, Raffaele; Ruth, Adam; Németh, György; Laszlovszky, István

doi:10.1016/j.schres.2013.11.041

Cited by 155 publications

(192 citation statements)

References 25 publications

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“…The efficacy and safety of cariprazine in the treatment of patients with schizophrenia have been evaluated in 3 positive randomized, placebo-controlled, phase 2/3 clinical studies. [13][14][15] Post hoc analyses of pooled data from these studies were conducted to investigate the effect of cariprazine on hostility in patients with acute exacerbation of schizophrenia.…”

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confidence: 99%

The Effect of Cariprazine on Hostility Associated With Schizophrenia

Citrome¹,

Durgam²,

Lu³

et al. 2016

J. Clin. Psychiatry

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The Effect of Cariprazine on Hostility Associated With Schizophrenia

Citrome¹,

Durgam²,

Lu³

et al. 2016

J. Clin. Psychiatry

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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‐05 (NCT01104779)11 was a fixed/flexible‐dose study with 2 cariprazine treatment arms (3‐6 mg/d or 6‐9 mg/d). RGH‐MD‐16 (NCT00694707)10 was a fixed‐dose study (cariprazine 1.5 mg/d, 3 mg/d or 4.5 mg/d); risperidone was included as an active control. Cariprazine doses were pooled for post hoc analyses in each disease state (schizophrenia, 1.5‐9 mg/d; bipolar mania, 3‐12 mg/d).…”

Section: Methodsmentioning

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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“…In phase II (cariprazine 1.5, 3.0, or 4.5 mg/day) [32] and two phase III (cariprazine 3 to 6 or 6 to 9 mg/day [33]; cariprazine 3 or 6 mg/day [34]) RCTs in patients with acute exacerbation of schizophrenia, cariprazine was effective and generally well tolerated at all doses tested (1.5-9 mg/day). A 26-week phase IIIb RCT of 461 patients with schizophrenia with persistent and predominant negative symptoms showed that cariprazine (target dose 4.5 mg/day) was more effective for negative symptoms compared to risperidone (target dose 4.0 mg/day) [35].…”

Section: New Drugs With Familiar Mechanismsmentioning

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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An evaluation of the safety and efficacy of cariprazine in patients with acute exacerbation of schizophrenia: A phase II, randomized clinical trial

Abstract: The results of this study support the efficacy and safety of cariprazine in patients with acute exacerbation of schizophrenia.

Cited by 155 publications

References 25 publications

The Effect of Cariprazine on Hostility Associated With Schizophrenia

The Effect of Cariprazine on Hostility Associated With Schizophrenia

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

Pharmacological Treatment of Schizophrenia:

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