Effect of cariprazine across the symptoms of mania in bipolar I disorder: Analyses of pooled data from phase II/III trials

European Neuropsychopharmacology

Volumn 25, Issue 11, 2015, Pages 1882-1891

  Vieta, Eduard ^a   Durgam, Suresh ^b   Lu, Kaifeng ^b   Ruth, Adam ^c   Debelle, Marc ^d   Zukin, Stephen ^b  

^a UNIVERSITY OF BARCELONA   (Spain)

^b FOREST RESEARCH INSTITUTE   (United States)

^c Prescott Medical Communications Group   (United States)

^d GEDEON RICHTER LTD   (Hungary)

Author keywords

Atypical antipsychotic; Bipolar disorder; Bipolar mania; Cariprazine; Residual symptoms

Indexed keywords

CARIPRAZINE; PLACEBO; PIPERAZINE DERIVATIVE; TRANQUILIZER;

ADULT; AGED; ARTICLE; BIPOLAR I DISORDER; DRUG EFFECT; FEMALE; HUMAN; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; MANIA; MIXED EFFECTS MODEL FOR REPEATED MEASURES; MODEL; MULTICENTER STUDY (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POST HOC ANALYSIS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); YOUNG MANIA RATING SCALE; ADOLESCENT; BIPOLAR DISORDER; CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; FOLLOW UP; HOSPITAL PATIENT; MIDDLE AGED; MULTICENTER STUDY; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PSYCHOLOGICAL RATING SCALE; RANDOMIZED CONTROLLED TRIAL; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTIMANIC AGENTS; BIPOLAR DISORDER; DOUBLE-BLIND METHOD; FEMALE; FOLLOW-UP STUDIES; HUMANS; INPATIENTS; MALE; MIDDLE AGED; PIPERAZINES; PSYCHIATRIC STATUS RATING SCALES; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84947208902     PISSN: 0924977X     EISSN: 18737862     Source Type: Journal    
DOI: 10.1016/j.euroneuro.2015.08.020     Document Type: Article

References (41)

1. Altshuler L.L., Gitlin M.J., Mintz J., Leight K.L., Frye M.A. Subsyndromal depression is associated with functional impairment in patients with bipolar disorder. J. Clin. Psychiatry 2002, 63:807-811.
2. American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders 2000, American Psychiatric Association, Washington, DC, Text Revision. fourth edition.
3. American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders 2013, American Psychiatric Association, Washington, DC. fifth edition.
4. Beaulieu J.M., Tirotta E., Sotnikova T.D., Masri B., Salahpour A., Gainetdinov R.R., Borrelli E., Caron M.G. Regulation of Akt signaling by D2 and D3 dopamine receptors in vivo. J. Neurosci. 2007, 27:881-885.
5. Calabrese J.R., Keck P.E., Starace A., Lu K., Ruth A., Laszlovszky I., Németh G., Durgam S. Efficacy and safety of low- and high-dose cariprazine in acute and mixed mania associated with bipolar I disorder: a double-blind, placebo-controlled study. J. Clin. Psychiatry 2015, 76:284-292.
6. Cho D.I., Zheng M., Kim K.M. Current perspectives on the selective regulation of dopamine D(2) and D(3) receptors. Arch. Pharm. Res. 2010, 33:1521-1538.
7. Durgam S., Starace A., Li D., Migliore R., Ruth A., Németh G., Laszlovszky I. The efficacy and tolerability of cariprazine in acute mania associated with bipolar I disorder: a phase II trial. Bipolar Disord. 2015, 17:63-75.
8. Graff-Guerrero A., Mamo D., Shammi C.M., Mizrahi R., Marcon H., Barsoum P., Rusjan P., Houle S., Wilson A.A., Kapur S. The effect of antipsychotics on the high-affinity state of D2 and D3 receptors: a positron emission tomography study With [11C]-(+)-PHNO. Arch. Gen. Psychiatry 2009, 66:606-615.
9. Grande I., Vieta E. Pharmacotherapy of acute mania: monotherapy or combination therapy with mood stabilizers and antipsychotics?. CNS Drugs 2015, 29:221-227.
10. Gyertyán I., Kiss B., Sághy K., Laszy J., Szabó G., Szabados T., Gémesi L.I., Pásztor G., Zájer-Balázs M., Kapás M., Csongor E.Á., Domány G., Tihanyi K., Szombathelyi Z. 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.
11. Horacek J., Bubenikova-Valesova V., Kopecek M., Palenicek T., Dockery C., Mohr P., Hoschl C. Mechanism of action of atypical antipsychotic drugs and the neurobiology of schizophrenia. CNS Drugs 2006, 20:389-409.
12. Jann M.W. Diagnosis and treatment of bipolar disorders in adults: a review of the evidence on pharmacologic treatments. Am. Health Drug Benefits 2014, 7:489-499.
13. Joffe R.T., MacQueen G.M., Marriott M., Trevor Young L. A prospective, longitudinal study of percentage of time spent ill in patients with bipolar I or bipolar II disorders. Bipolar Disord. 2004, 6:62-66.
14. Joyce J.N., Millan M.J. Dopamine D3 receptor antagonists as therapeutic agents. Drug Discov. Today 2005, 10:917-925.
15. Judd L.L., Akiskal H.S., Schettler P.J., Endicott J., Leon A.C., Solomon D.A., Coryell W., Maser J.D., Keller M.B. Psychosocial disability in the course of bipolar I and II disorders: a prospective, comparative, longitudinal study. Arch. Gen. Psychiatry 2005, 62:1322-1330.
16. Judd L.L., Akiskal H.S., Schettler P.J., Endicott J., Maser J., Solomon D.A., Leon A.C., Rice J.A., Keller M.B. The long-term natural history of the weekly symptomatic status of bipolar I disorder. Arch. Gen. Psychiatry 2002, 59:530-537.
17. Judd L.L., Schettler P.J., Akiskal H.S., Coryell W., Leon A.C., Maser J.D., Solomon D.A. Residual symptom recovery from major affective episodes in bipolar disorders and rapid episode relapse/recurrence. Arch. Gen. Psychiatry 2008, 65:386-394.
18. Kiss B., Horváth A., Némethy Z., Schmidt E., Laszlovszky I., Bugovics G., Fazekas K., Hornok K., Orosz S., Gyertyán I., Agai-Csongor E., Domány G., Tihanyi K., Adham N., Szombathelyi Z. 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.
19. Laszy J., Laszlovszky I., Gyertyán I. Dopamine D3 receptor antagonists improve the learning performance in memory-impaired rats. Psychopharmacology 2005, 179:567-575.
20. Leboyer M., Kupfer D.J. Bipolar disorder: new perspectives in health care and prevention. J. Clin. Psychiatry 2010, 71:1689-1695.
21. Marangell L.B., Dennehy E.B., Miyahara S., Wisniewski S.R., Bauer M.S., Rapaport M.H., Allen M.H. The functional impact of subsyndromal depressive symptoms in bipolar disorder: data from STEP-BD. J. Affect. Disord. 2009, 114:58-67.
22. McIntyre R.S., Konarski J.Z., Jones M., Paulsson B. Quetiapine in the treatment of acute bipolar mania: efficacy across a broad range of symptoms. J. Affect. Disord. 2007, 100(Suppl. 1):S5-14.
23. Mizrahi R., Agid O., Borlido C., Suridjan I., Rusjan P., Houle S., Remington G., Wilson A.A., Kapur S. Effects of antipsychotics on D3 receptors: a clinical PET study in first episode antipsychotic naive patients with schizophrenia using [11C]-(+)-PHNO. Schizophr. Res. 2011, 131:63-68.
24. Montgomery S.A., Asberg M. A new depression scale designed to be sensitive to change. Br. J. Psychiatry 1979, 134:382-389.
25. Nivoli A.M., Colom F., Murru A., Pacchiarotti I., Castro-Loli P., Gonzalez-Pinto A., Fountoulakis K.N., Vieta E. New treatment guidelines for acute bipolar depression: a systematic review. J. Affect. Disord. 2011, 129:14-26.
26. Perlis R.H., Ostacher M.J., Patel J.K., Marangell L.B., Zhang H., Wisniewski S.R., Ketter T.A., Miklowitz D.J., Otto M.W., Gyulai L., Reilly-Harrington N.A., Nierenberg A.A., Sachs G.S., Thase M.E. Predictors of recurrence in bipolar disorder: primary outcomes from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Am. J. Psychiatry 2006, 163:217-224.
27. Posner K., Brown G.K., Stanley B., Brent D.A., Yershova K.V., Oquendo M.A., Currier G.W., Melvin G.A., Greenhill L., Shen S., Mann J.J. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am. J. Psychiatry 2011, 168:1266-1277.
28. Riley R.D., Lambert P.C., Abo-Zaid G. Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ 2010, 340:c221.
29. Sachs G.S., Dupuy J.M., Wittmann C.W. The pharmacologic treatment of bipolar disorder. J. Clin. Psychiatry 2011, 72:704-715.
30. Sachs G.S., Greenberg W.M., Starace A., Lu K., Ruth A., Laszlovszky I., Németh G., Durgam S. Cariprazine in the treatment of acute mania in bipolar I disorder: a double-blind, placebo-controlled, Phase III trial. J. Affect. Disord. 2015, 174:296-302.
31. Schwartz J.C., Diaz J., Pilon C., Sokoloff P. Possible implications of the dopamine D(3) receptor in schizophrenia and in antipsychotic drug actions. Brain Res. Brain Res. Rev. 2000, 31:277-287.
32. Slifstein M., Abi-Dargham A., D'Souza D.C., R.E.C., Laszlovszky I., Durgam S., Adham N., Kiss B., Gyertyán I., Kapás M., Lee Y. Cariprazine demonstrates high dopamine D3 and D2 receptor occupancy in patients with schizophrenia: a clinical PET study with [11C]-(+)-PHNO. Neuropsychopharmacology 2013, 38:S520.
33. Tohen M., Bowden C.L., Calabrese J.R., Lin D., Forrester T.D., Sachs G.S., Koukopoulos A., Yatham L., Grunze H. Influence of sub-syndromal symptoms after remission from manic or mixed episodes. Br. J. Psychiatry 2006, 189:515-519.
34. Tohen M., Frank E., Bowden C.L., Colom F., Ghaemi S.N., Yatham L.N., Malhi G.S., Calabrese J.R., Nolen W.A., Vieta E., Kapczinski F., Goodwin G.M., Suppes T., Sachs G.S., Chengappa K.R., Grunze H., Mitchell P.B., Kanba S., Berk M. The International Society for Bipolar Disorders (ISBD) Task Force report on the nomenclature of course and outcome in bipolar disorders. Bipolar Disord. 2009, 11:453-473.
35. Vieta E. The bipolar maze: a roadmap through translational psychopathology. Acta Psychiatr. Scand. 2014, 129:323-327.
36. Vieta E. Personalised medicine applied to mental health: precision psychiatry. Rev. Psiquiatr. Salud Ment. 2015, 8:117-118.
37. Vieta E., Grunze H., Azorin J.M., Fagiolini A. Phenomenology of manic episodes according to the presence or absence of depressive features as defined in DSM-5: results from the IMPACT self-reported online survey. J. Affect. Disord. 2014, 156:206-213.
38. Vieta E., Sanchez-Moreno J., Lahuerta J., Zaragoza S., Group E. Subsyndromal depressive symptoms in patients with bipolar and unipolar disorder during clinical remission. J. Affect. Disord. 2008, 107:169-174.
39. Yatham L.N., Goldstein J.M., Vieta E., Bowden C.L., Grunze H., Post R.M., Suppes T., Calabrese J.R. Atypical antipsychotics in bipolar depression: potential mechanisms of action. J. Clin. Psychiatry 2005, 66(Suppl. 5):S40-S48.
40. Yatham, L.N., Lu, K., Ruth, A., Németh, G., Laszlovszky, I., Earley, W., Durgam, S., 2015. Response and remission rates and number needed to treat with cariprazine in patients with bipolar mania: analyses from 3 phase II/III trials. In: Proceedings of the 168th Annual Meeting of the American Psychiatric Association. May 16-20, Toronto, Canada.
41. Young R.C., Biggs J.T., Ziegler V.E., Meyer D.A. A rating scale for mania: reliability, validity and sensitivity. Br. J. Psychiatry 1978, 133:429-435.