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Kim S J Lao, Ying He, Ian C K Wong, Frank M C Besag, Esther W Chan
BACKGROUND: Cariprazine is a novel antipsychotic agent recently approved for treating schizophrenia and bipolar mania in the USA. The sample sizes of published randomized controlled trials (RCTs) of the drug are small; previous meta-analyses included few RCTs and did not specifically investigate the tolerability/safety profile of cariprazine. OBJECTIVE: Our objective was to conduct a meta-analysis of published RCTs to systematically review the tolerability and safety of cariprazine versus placebo...
August 22, 2016: CNS Drugs
Ragy R Girgis, Mark Slifstein, Deepak D'Souza, Yih Lee, Antonia Periclou, Parviz Ghahramani, István Laszlovszky, Suresh Durgam, Nika Adham, Nabeel Nabulsi, Yiyun Huang, Richard E Carson, Béla Kiss, Margit Kapás, Anissa Abi-Dargham, Ashok Rakhit
RATIONALE: Second-generation antipsychotics occupy dopamine D2 receptors and act as antagonists or partial agonists at these receptors. While these drugs alleviate positive symptoms in patients with schizophrenia, they are less effective for treating cognitive deficits and negative symptoms. Dopamine D3 receptors are highly expressed in areas of the brain thought to play a role in the regulation of motivation and reward-related behavior. Consequently, the dopamine D3 receptor has become a target for treating negative symptoms in combination with D2 antagonism to treat positive symptoms in patients with schizophrenia...
October 2016: Psychopharmacology
Rona Jeannie Roberts, Lillian Jan Findlay, Peggy L El-Mallakh, Rif S El-Mallakh
Schizophrenia and bipolar disorder are severe psychiatric disorders that are frequently associated with persistent symptoms and significant dysfunction. While there are a multitude of psychopharmacologic agents are available for treatment of these illnesses, suboptimal response and significant adverse consequences limit their utility. Cariprazine is a new, novel antipsychotic medication with dopamine D2 and D3 partial agonist effects. Its safety and efficacy have been investigated in acute psychosis of schizophrenia, bipolar mania, bipolar depression, and unipolar depression...
2016: Neuropsychiatric Disease and Treatment
Leslie Citrome
Cariprazine is an antipsychotic medication and received approval by the U.S. Food and Drug Administration for the treatment of schizophrenia in September 2015. Cariprazine is a dopamine D3 and D2 receptor partial agonist, with a preference for the D3 receptor. Cariprazine is also a partial agonist at the serotonin 5-HT1A receptor and acts as an antagonist at 5-HT2B and 5-HT2A receptors. The recommended dose range of cariprazine for the treatment of schizophrenia is 1.5-6 mg/d; the starting dose of 1.5 mg/d is potentially therapeutic...
2016: Clinical Schizophrenia & related Psychoses
Suresh Durgam, Willie Earley, Rui Li, Dayong Li, Kaifeng Lu, István Laszlovszky, W Wolfgang Fleischhacker, Henry A Nasrallah
Cariprazine, a dopamine D3/D2 receptor partial agonist with preference for D3 receptors, has demonstrated efficacy in randomized controlled trials in schizophrenia. This multinational, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of cariprazine for relapse prevention in adults with schizophrenia; total study duration was up to 97weeks. Schizophrenia symptoms were treated/stabilized with cariprazine 3-9mg/d during 20-week open-label treatment consisting of an 8-week, flexible-dose run-in phase and a 12-week fixed-dose stabilization phase...
October 2016: Schizophrenia Research
Domenico De Berardis
Cariprazine (RGH-188) is a novel antipsychotic drug that exerts partial agonism of dopamine D2/D3 receptors with preferential binding to D3 receptor, antagonism of 5HT2B receptors and partial agonism of 5HT1A. Currently, cariprazine is in late-stage clinical development (phase III clinical trials) in patients with schizophrenia (S) and in patients with bipolar disorder (BD), as well as an adjunctive treatment in patients with Major Depressive Disorder (MDD) and drug-resistant MDD. Cariprazine has completed phase III trials for the acute treatment of schizophrenia and bipolar mania, phase II trials for the bipolar depression and MDD whilst it is undergoing phase III trials as an adjunct to antidepressants...
June 30, 2016: Current Pharmaceutical Design
Fang Fang, Hongwei Sun, Zuowei Wang, Ming Ren, Joseph R Calabrese, Keming Gao
Somnolence is a common side effect of antipsychotics. To assess the incidence of this side effect, we performed a MEDLINE search for randomized, double-blinded, placebo- or active-controlled studies of adult patients treated with antipsychotics for schizophrenia, mania, bipolar depression, or bipolar disorder. We extracted rates of somnolence from original publications and pooled them based on the dose of each antipsychotic in the same psychiatric condition, then estimated the absolute risk increase (ARI) and the number needed to harm (NNH) of an antipsychotic relative to placebo or an active comparator in the same psychiatric condition...
September 2016: CNS Drugs
Ather Muneer
In the majority of cases of bipolar disorder, manic episodes are usually brief and typically responsive to currently available psychopharmacological agents. In contrast, depressive manifestations are more prevalent and persistent, and can present as major depressive/mixed episodes or residual interepisode symptoms. The depressive phase is often associated with other neuropsychiatric conditions, such as anxiety spectrum disorders, substance use disorders, stressor-related disorders, and eating disorders. It is viewed as a systemic disease with associated ailments such as metabolic syndrome, diabetes mellitus, and cardiovascular disease...
May 2016: Korean Journal of Family Medicine
Ather Muneer
Bipolar disorder is characterized by exacerbations of opposite mood polarity, ranging from manic to major depressive episodes. In the current nosological system of the Diagnostic and Statistical Manual - 5(th) edition (DSM-5), it is conceptualized as a spectrum disorder consisting of bipolar disorder type I, bipolar disorder type II, cyclothymic disorder, and bipolar disorder not otherwise specified. Treatment of all phases of this disorder is primarily with mood stabilizers, but many patients either show resistance to the conventional mood stabilizing medications or are intolerant to their side-effects...
2016: Curēus
(no author information available yet)
No abstract text is available yet for this article.
April 25, 2016: Medical Letter on Drugs and Therapeutics
P De Deurwaerdère
Cariprazine (RGH-188, MP-214, Vraylar[TM]) is a new dopamine receptor ligand developed for the treatment of several neuropsychiatric diseases including schizophrenia and bipolar disorders. Cariprazine displays higher affinity at dopamine D3 receptors and a similar affinity at D2 and 5-HT2B receptors. At variance with some atypical antipsychotics, its affinity at 5-HT1A, 5-HT2A and histamine H1 receptors is modest compared with its three main targets. Cariprazine could correspond to a biased agonist at dopamine receptors, displaying either antagonist or partial agonist properties depending on the signaling pathways linked to D2/D3 receptors...
February 2016: Drugs of Today
Lillian Jan Findlay, Peggy L El-Mallakh, Rif S El-Mallakh
PURPOSE: To review the data regarding a new antipsychotic, cariprazine. CONCLUSIONS: Cariprazine is a dopamine D3, D2 partial agonist, with greater affinity to D3. It has been examined for schizophrenia, bipolar mania, bipolar depression, and unipolar depression. It has demonstrated efficacy in schizophrenia and mania, and has recently been approved by the U.S. Food and Drug Administration. However, it has a more inconsistent effect in depression, both unipolar and bipolar...
April 5, 2016: Perspectives in Psychiatric Care
Suresh Durgam, Willie Earley, Hua Guo, Dayong Li, György Németh, István Laszlovszky, Maurizio Fava, Stuart A Montgomery
BACKGROUND: Cariprazine is an atypical antipsychotic currently under investigation as adjunctive therapy in patients with major depressive disorder (MDD) who have inadequate response to standard antidepressant therapy. METHOD: A randomized, double-blind, placebo-controlled, flexible-dose study was conducted from December 2011 to December 2013 in adults who met DSM-IV-TR criteria for MDD and had an inadequate antidepressant response. Eligible patients were randomized to 8-week adjunctive treatment with placebo (n = 269), cariprazine 1-2 mg/d (n = 274), or cariprazine 2-4...
March 2016: Journal of Clinical Psychiatry
Daniel A Hussar, Rebecca Shatynski
No abstract text is available yet for this article.
March 2016: Journal of the American Pharmacists Association: JAPhA
Stephen M Stahl
Cariprazine is a new therapeutic agent recently approved for the treatment of both schizophrenia and manic or mixed episodes associated with bipolar disorder, and is under investigation for the treatment of both bipolar depression and major depressive disorder.
April 2016: CNS Spectrums
Leslie Citrome, Suresh Durgam, Kaifeng Lu, Paul Ferguson, István Laszlovszky
OBJECTIVE: Although most patients with schizophrenia are not aggressive, individuals with the disorder have increased risk of hostile behavior. Cariprazine, a dopamine D3 and D2 receptor partial agonist antipsychotic with preferential binding to D3 receptors, was evaluated for antihostility effects in patients with schizophrenia. METHOD: Post hoc analyses were conducted using pooled data from 3 positive randomized, placebo-controlled, phase 2/3 studies in inpatients (18-60 years) with acute exacerbation of schizophrenia according to DSM-IV-TR criteria; data were collected between 2008 and 2011...
January 2016: Journal of Clinical Psychiatry
Paul L McCormack
No abstract text is available yet for this article.
March 2016: Drugs
Tadakatsu Nakamura, Tomoko Kubota, Atsushi Iwakaji, Masayoshi Imada, Margit Kapás, Yasunori Morio
PURPOSE: Cariprazine is a potent dopamine D3-preferring D3/D2 receptor partial agonist in development for the treatment of schizophrenia, bipolar mania, and depression. Pharmacokinetics of cariprazine and the two clinically relevant metabolites (desmethyl- and didesmethyl-cariprazine) was evaluated in a clinical pharmacology study. METHODS: This was a multicenter, randomized, open-label, parallel-group, fixed-dose (3, 6, or 9 mg/day) study of 28-week duration (≤4-week observation, 12-week open-label treatment, and 12-week follow-up)...
2016: Drug Design, Development and Therapy
Ricardo P Garay, Leslie Citrome, Ludovic Samalin, Chen-Chung Liu, Morten S Thomsen, Christoph U Correll, Ahcène Hameg, Pierre-Michel Llorca
INTRODUCTION: In this review, the authors describe medications in phase III of clinical development for schizophrenia and schizoaffective disorder, and provide an opinion on how current treatment can be improved in the near future. AREAS COVERED: Recent (post 2013) phase III clinical trials of schizophrenia-targeted therapies were found in US and EU clinical trial registries. Two hundred fifty-three trials were identified, that included 16 investigational compounds...
2016: Expert Opinion on Pharmacotherapy
Suresh Durgam, Andrew J Cutler, Kaifeng Lu, Raffaele Migliore, Adam Ruth, István Laszlovszky, György Németh, Herbert Y Meltzer
OBJECTIVE: This phase 3 study evaluated the efficacy, safety, and tolerability of cariprazine in patients with acute exacerbation of schizophrenia. METHOD: This multinational, randomized, double-blind, placebo- and active-controlled study was conducted from April 2010 to December 2011. Patients who met DSM-IV-TR criteria for schizophrenia were randomized to placebo (n = 153), cariprazine 3 mg/d (n = 155), cariprazine 6 mg/d (n = 157), or aripiprazole 10 mg/d (n = 152) for 6 weeks of double-blind treatment...
December 2015: Journal of Clinical Psychiatry
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