The efficacy and tolerability of cariprazine in acute mania associated with bipolar I disorder: A phase II trial

Bipolar Disorders

Volumn 17, Issue 1, 2015, Pages 63-75

  Durgam, Suresh ^a   Starace, Anju ^a   Li, Dayong ^a   Migliore, Raffaele ^a   Ruth, Adam ^b   Németh, György ^c   Laszlovszky, István ^c  

^a FOREST RESEARCH INSTITUTE   (United States)

^b Prescott Medical Communications Group   (United States)

^c GEDEON RICHTER LTD   (Hungary)

Author keywords

Antipsychotic agents; Bipolar disorder; Cariprazine; Dopamine agents; Dopamine D3 receptors; Schizophrenia

Indexed keywords

CARIPRAZINE; CHLORAL HYDRATE; ESZOPICLONE; LORAZEPAM; PLACEBO; ZALEPLON; ZOLPIDEM; NEUROLEPTIC AGENT; PIPERAZINE DERIVATIVE;

ABNORMAL INVOLUNTARY MOVEMENT SCALE; ACUTE MANIA; ADULT; AKATHISIA; ARTICLE; BIPOLAR I DISORDER; CLINICAL GLOBAL IMPRESSION SCALE; CONSTIPATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG TOLERABILITY; DSM-IV-TR; DYSPEPSIA; EXTRAPYRAMIDAL SYNDROME; FEMALE; HUMAN; IN VITRO STUDY; INSOMNIA; MAJOR CLINICAL STUDY; MALE; MANIA; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; YOUNG MANIA RATING SCALE; AKATHISIA, DRUG-INDUCED; BASAL GANGLIA DISEASES; BIPOLAR DISORDER; CHEMICALLY INDUCED; CLINICAL TRIAL; DOSE RESPONSE; DRUG MONITORING; MIDDLE AGED; PROCEDURES; PSYCHOLOGICAL RATING SCALE; PSYCHOLOGY; TREATMENT OUTCOME;

ADULT; AKATHISIA, DRUG-INDUCED; ANTIPSYCHOTIC AGENTS; BASAL GANGLIA DISEASES; BIPOLAR DISORDER; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG MONITORING; FEMALE; HUMANS; MALE; MIDDLE AGED; PIPERAZINES; PSYCHIATRIC STATUS RATING SCALES; TREATMENT OUTCOME;

EID: 84921600142     PISSN: 13985647     EISSN: 13995618     Source Type: Journal    
DOI: 10.1111/bdi.12238     Document Type: Article

References (29)

1. Altshuler LL, Gitlin MJ, Mintz J, Leight KL, Frye MA. Subsyndromal depression is associated with functional impairment in patients with bipolar disorder. J Clin Psychiatry 2002; 63: 807-811.
2. Tohen M, Bowden CL, Calabrese Jr. et al. Influence of sub-syndromal symptoms after remission from manic or mixed episodes. Br J Psychiatry 2006; 189: 515-519.
3. Judd LL, Schettler PJ, Akiskal HS et al. Residual symptom recovery from major affective episodes in bipolar disorders and rapid episode relapse/recurrence. Arch Gen Psychiatry 2008; 65: 386-394.
4. Kiss B, Horváth A, Némethy Z et al. Cariprazine (RGH-188), a dopamine D(3) receptor-preferring, D(3)/D(2) dopamine receptor antagonist-partial agonist antipsychotic candidate: in vitro and neurochemical profile. J Pharmacol Exp Ther 2010; 333: 328-340.
5. Kiss B, Horti F, Bobok A. Cariprazine, a D3/D2 dopamine receptor partial agonist antipsychotic, displays greater D3 receptor occupancy in vivo compared with other antipsychotics. Schizophr Res 2012; 136 (Suppl. 1): S190.
6. Nord M, Farde L. Antipsychotic occupancy of dopamine receptors in schizophrenia. CNS Neurosci Ther 2011; 17: 97-103.
7. Cho DI, Zheng M, Kim KM. Current perspectives on the selective regulation of dopamine D(2) and D(3) receptors. Arch Pharm Res 2010; 33: 1521-1538.
8. Gross G, Drescher K. The role of dopamine D(3) receptors in antipsychotic activity and cognitive functions. Handb Exp Pharmacol 2012; 213: 167-210.
9. Gyertyán I, Sághy K, Laszy J et al. Subnanomolar dopamine D3 receptor antagonism coupled to moderate D2 affinity results in favourable antipsychotic-like activity in rodent models: II. Behavioural characterisation of RG-15. Naunyn Schmiedebergs Arch Pharmacol 2008; 378: 529-539.
10. Kiss B, Laszlovszky I, Horváth A et al. Subnanomolar dopamine D3 receptor antagonism coupled to moderate D2 affinity results in favourable antipsychotic-like activity in rodent models: I. Neurochemical characterisation of RG-15. Naunyn Schmiedebergs Arch Pharmacol 2008; 378: 515-528.
11. Adham N, Samoriski G, Gao Y et al. Cariprazine (RGH-188), a potential antipsychotic with dopamine D3/D2 functional antagonist properties, attenuates manic-like behaviors in animal models. World J Biol Psychiatry 2009; 10 (Suppl. 1): 304.
12. Gyertyán I, Kiss B, Sághy K et al. Cariprazine (RGH-188), a potent D3/D2 dopamine receptor partial agonist, binds to dopamine D3 receptors in vivo and shows antipsychotic-like and procognitive effects in rodents. Neurochem Int 2011; 59: 925-935.
13. Duman RS, Duric V, Banasr M, Adham N, Kiss B, Gyertyán I. Cariprazine exhibits dopamine D3 receptor-dependent antidepressant-like activity in the chronic unpredictable stress model of anhedonia. Neuropsychopharmacology 2012; 38 (Suppl. 1): S84.
14. Zimnisky R, Chang G, Gyertyán I, Kiss B, Adham N, Schmauss C. Cariprazine, a dopamine D(3)-receptor-preferring partial agonist, blocks phencyclidine-induced impairments of working memory, attention set-shifting, and recognition memory in the mouse. Psychopharmacology 2013; 226: 91-100.
15. Guy W. The Clinician Global Severity and Impression Scales. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: National Institute of Mental Health, 1976: 218-222. DHEW Publication No. 76-338.
16. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th edn, text revision. Washington, DC: American Psychiatric Association, 2000.
17. Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978; 133: 429-435.
18. Montgomery SA, Åsberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134: 382-389.
19. Guy W. The Abnormal Movement Scale. ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: National Institute of Mental Health, 1976: 218-222. DHEW Publication No. 76-338.
20. Barnes TR. A rating scale for drug-induced akathisia. Br J Psychiatry 1989; 154: 672-676.
21. Simpson GM, Angus JW. A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 1970; 212: 11-19.
22. Kay SR, Fiszbein A, Opler LA. The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophr Bull 1987; 13: 261-276.
23. FDA. Guidance for Industry. Drug-Induced Liver Injury: Premarketing Clinical Evaluation, 2009. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM174090.pdf [accessed February 2013].
24. Ketter TA, Citrome L, Wang PW, Culver JL, Srivastava S. Treatments for bipolar disorder: can number needed to treat/harm help inform clinical decisions? Acta Psychiatr Scand 2011; 123: 175-189.
25. Srivastava S, Ketter TA. Clinical relevance of treatments for acute bipolar disorder: balancing therapeutic and adverse effects. Clin Ther 2011; 33: B40-B48.
26. Perlis RH, Welge JA, Vornik LA, Hirschfeld RM, Keck PE Jr. Atypical antipsychotics in the treatment of mania: a meta-analysis of randomized, placebo-controlled trials. J Clin Psychiatry 2006; 67: 509-516.
27. Yildiz A, Vieta E, Leucht S, Baldessarini RJ. Efficacy of antimanic treatments: meta-analysis of randomized, controlled trials. Neuropsychopharmacology 2011; 36: 375-389.
28. Knesevich M, Papadakis K, Bose A, Andor G, Laszlovszky I. The efficacy and tolerability of cariprazine in acute mania associated with bipolar I disorder: a phase II trial. Eur Neuropsychopharmacol 2009; 19 (Suppl. 3): S469-S470.
29. Tamayo JM, Zarate CA Jr, Vieta E, Vazquez G, Tohen M. Level of response and safety of pharmacological monotherapy in the treatment of acute bipolar I disorder phases: a systematic review and meta-analysis. Int J Neuropsychopharmacol 2010; 13: 813-832.