An 8-week randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of cariprazine in patients with bipolar I depression

American Journal of Psychiatry

Volumn 173, Issue 3, 2016, Pages 271-281

  Durgam, Suresh ^a   Earley, Willie ^a   Lipschitz, Alan ^a   Guo, Hua ^a   Laszlovszky, István ^a   Németh, György ^a   Vieta, Eduard ^a   Calabrese, Joseph R ^a   Yatham, Lakshmi N ^a  

^a UNIVERSITY OF BARCELONA   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

CARIPRAZINE; DIAZEPAM; LORAZEPAM; PLACEBO; NEUROLEPTIC AGENT; PIPERAZINE DERIVATIVE;

ADULT; AGED; AKATHISIA; ARTICLE; BIPOLAR DEPRESSION; BIPOLAR I DISORDER; CLINICAL GLOBAL IMPRESSION SCALE; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEADACHE; HUMAN; INSOMNIA; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MENTAL PATIENT; MONTGOMERY ASBERG DEPRESSION RATING SCALE; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PARALLEL DESIGN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; SOMNOLENCE; WEIGHT GAIN; BIPOLAR DISORDER; CLINICAL TRIAL; DEPRESSION; DOSE RESPONSE; DRUG MONITORING; MIDDLE AGED; PSYCHOLOGICAL RATING SCALE; PSYCHOLOGY; TREATMENT OUTCOME;

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

EID: 84959491677     PISSN: 0002953X     EISSN: 15357228     Source Type: Journal    
DOI: 10.1176/appi.ajp.2015.15020164     Document Type: Article

References (45)

1. Baldessarini RJ, Vieta E, Calabrese JR, et al: Bipolar depression: overview and commentary. Harv Rev Psychiatry 2010;18:143-157
2. Baldessarini RJ, Salvatore P, Khalsa HM, et al: Morbidity in 303 first-episode bipolar I disorder patients. Bipolar Disord 2010;12:264-270
3. Latuda (package insert). Marlborough, Mass, Sunovion Pharmaceuticals, 2013
4. Seroquel (package insert). Wilmington, Del, Astra Zeneca Pharmacueticals, 2013
5. 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
6. 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
7. Graff-Guerrero A, Mamo D, Shammi CM, et al: 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
8. Mizrahi R, Agid O, Borlido C, et al: 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
9. Slifstein M, Abi-Dargham A, D'Souza DC, et al: Cariprazine demonstrates high dopamine D3 and D2 receptor occupancy in patients with schizophrenia: a clinical PET study with [11C]-(+)-PHNO. Neuropsychopharmacology 2013;38:S520 [Abstract]
10. Pizzagalli DA: Depression, stress, and anhedonia: toward a synthesis and integrated model. Annu Rev Clin Psychol 2014;10:393-423
11. Leggio GM, Salomone S, Bucolo C, et al: Dopamine D (3) receptor as a new pharmacological target for the treatment of depression. Eur J Pharmacol 2013;719:25-33
12. Moraga-Amaro R, Gonzalez H, Pacheco R, et al: Dopamine receptor D3 deficiency results in chronic depression and anxiety. Behav Brain Res 2014;274:186-193
13. Duman RS, Duric V, Banasr M, et al: Cariprazine exhibits dopamine D3 receptor-dependent antidepressant-like activity in the chronic unpredictable stress model of anhedonia. Neuropsychopharmacol. 2012;38(S1):S84 [Abstract]
14. Papp M, Gruca P, Lasoń-Tyburkiewicz M, et al: Attenuation of anhedonia by cariprazine in the chronic mild stress model of depression. Behav Pharmacol 2014;25:567-574
15. Blier P, Bergeron R, de Montigny C: Selective activation of postsynaptic 5-HT1A receptors induces rapid antidepressant response. Neuropsychopharmacology 1997;16:333-338
16. Calabrese JR, Keck PE Jr, Starace A, et al: Efficacy and safety of lowand 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
17. Durgam S, Starace A, Li D, et al: The efficacy and tolerability of cariprazine in acute mania associated with bipolar I disorder: a phase II trial. Bipolar Disord 2015;17:63-75
18. Sachs GS, Greenberg WM, Starace A, et al: 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
19. Ahuja S, Bose A, Lu K, et al: A multicenter, randomized, doubleblind trial to evaluate the effect of cariprazine in bipolar depression. Poster presented at the Autumn Conference of the International Society for CNS Clinical Trials and Methodology, Amelia Island, Fla, Oct. 3-4, 2011
20. Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960;23:56-62
21. Guy W: ECDEU Assessment Manual for Psychopharmacology. Publication ADM 76-338. Washington, DC, US Department of Health, Education, and Welfare, 1976, pp 218-222
22. Montgomery SA, Asberg M: A new depression scale designed to be sensitive to change. Br J Psychiatry 1979;134:382-389
23. Young RC, Biggs JT, Ziegler VE, et al: A rating scale for mania: reliability, validity, and sensitivity. Br J Psychiatry 1978;133:429-435
24. Posner K, Brown GK, Stanley B, et al: 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
25. Barnes TR: Arating scale for drug-induced akathisia. Br J Psychiatry 1989;154:672-676
26. Guy W: ECDEU Assessment Manual for Psychopharmacology: Publication ADM 76-338. Washington, DC, US Department of Health, Education, and Welfare, 1976, pp 534-537
27. Simpson GM, Angus JW: A rating scale for extrapyramidal side effects. Acta Psychiatr Scand Suppl 1970;212:11-19
28. Kenward MG, Molenberghs G, Thijs H: Pattern-mixture models with proper time dependence. Biometrika 2003;90:53-71
29. Bech P, Tanghøj P, Andersen HF, et al: Citalopram dose-response revisited using an alternative psychometric approach to evaluate clinical effects of four fixed citalopram doses compared to placebo in patients with major depression. Psychopharmacology (Berl) 2002;163:20-25
30. Chen X, Luo X, Capizzi T: The application of enhanced parallel gatekeeping strategies. Stat Med 2005;24:1385-1397
31. Müller MJ, Szegedi A, Wetzel H, et al: Moderate and severe depression: gradations for the Montgomery-Asberg Depression Rating Scale. J Affect Disord 2000;60:137-140
32. Calabrese JR, Keck PE Jr, Macfadden W, et al: A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry 2005;162:1351-1360
33. Thase ME, Macfadden W, Weisler RH, et al: Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebocontrolled study (the BOLDER II study). J Clin Psychopharmacol 2006;26:600-609
34. Young AH, McElroy SL, Bauer M, et al: A double-blind, placebocontrolled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry 2010;71:150-162
35. McElroy SL, Weisler RH, Chang W, et al: A double-blind, placebocontrolled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry 2010;71:163-174
36. Suppes T, Datto C, Minkwitz M, et al: Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. J Affect Disord 2010;121:106-115
37. Loebel A, Cucchiaro J, Silva R, et al: Lurasidone monotherapy in the treatment of bipolar I depression: a randomized, double-blind, placebo-controlled study. Am J Psychiatry 2014;171:160-168
38. Tohen M, McDonnell DP, Case M, et al: Randomised, double-blind, placebo-controlled study of olanzapine in patients with bipolar I depression. Br J Psychiatry 2012;201:376-382
39. Tohen M, Vieta E, Calabrese J, et al: Efficacy of olanzapine and olanzapine-fluoxetine combination in the treatment of bipolar I depression. Arch Gen Psychiatry 2003;60:1079-1088
40. De Fruyt J, Deschepper E, Audenaert K, et al: Second generation antipsychotics in the treatment of bipolar depression: a systematic review and meta-analysis. J Psychopharmacol 2012;26:603-617
41. Cruz N, Sanchez-Moreno J, Torres F, et al: Efficacy of modern antipsychotics in placebo-controlled trials in bipolar depression: a meta-analysis. Int J Neuropsychopharmacol 2010;13:5-14
42. Lombardo I, Sachs G, Kolluri S, et al: Two 6-week, randomized, double-blind, placebo-controlled studies of ziprasidone in outpatients with bipolar I depression: did baseline characteristics impact trial outcome? J Clin Psychopharmacol 2012;32:470-478
43. Thase ME, Jonas A, Khan A, et al: Aripiprazole monotherapy in nonpsychotic bipolar I depression: results of 2 randomized, placebocontrolled studies. J Clin Psychopharmacol 2008;28:13-20
44. Pacchiarotti I, Bond DJ, Baldessarini RJ, et al: The International Society for Bipolar Disorders (ISBD) task force report on antidepressant use in bipolar disorders. Am J Psychiatry 2013;170:1249-1262
45. Correll CU, Frederickson AM, Kane JM, et al: Equally increased risk for metabolic syndrome in patients with bipolar disorder and schizophrenia treated with second-generation antipsychotics. Bipolar Disord 2008;10:788-797