A failed 6-week, randomized, double-blind, placebo-controlled study of once-daily extended release quetiapine fumarate in patients with acute schizophrenia: Lessons learned

Psychopharmacology Bulletin

Volumn 44, Issue 4, 2011, Pages 37-69

  Cutler, Andrew J ^a   Tran Johnson, Tram ^b   Kalali, Amir ^c   Åström, Mikael ^d   Brecher, Martin ^e   Meulien, Didier ^d  

^a UNIVERSITY OF FLORIDA COLLEGE OF MEDICINE   (United States)

^b CNRI San Diego   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d ASTRAZENECA R AND D   (Sweden)

^e ASTRAZENECA R AND D   (Sweden)

Author keywords

Atypical antipsychotic; Clinical trial; Extended release; Quetiapine; Schizophrenia

Indexed keywords

QUETIAPINE;

ADULT; AGED; AGITATION; ARTHRALGIA; ARTICLE; BODY WEIGHT; CHOLESTEROL BLOOD LEVEL; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; EXTENDED RELEASE DRUG FORMULATION; EXTRAPYRAMIDAL SYMPTOM; FATIGUE; FEMALE; GLUCOSE BLOOD LEVEL; HUMAN; INSOMNIA; INSULIN BLOOD LEVEL; LIPOPROTEIN BLOOD LEVEL; MAJOR CLINICAL STUDY; MALE; NAUSEA; OUTCOME ASSESSMENT; PROLACTIN BLOOD LEVEL; PSYCHOSIS; RANDOMIZED CONTROLLED TRIAL; SCHIZOPHRENIA; SEDATION; SIDE EFFECT; SOMNOLENCE; STOMACH DISCOMFORT; SYNCOPE; TRIACYLGLYCEROL BLOOD LEVEL; UNCONSCIOUSNESS; VOMITING; WEIGHT GAIN; XEROSTOMIA;

EID: 84863548770     PISSN: 00485764     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (36)

1. Arvanitis LA, Miller BG, the Seroquel Trial 13 study group. Multiple fixed doses of "Seroquel" (quetiapine) in patients with acute exacerbation of schizophrenia: a comparison with haloperidol and placebo. Biol Psychiatry. 1997;42:233-246.
2. Buckley PF. Efficacy of quetiapine for the treatment of schizophrenia: a combined analysis of three placebo-controlled trials. Curr Med Res Opin. 2004;20:1357-1363.
3. ®: evidence for efficacy in the treatment of hostility and aggression. Schizophr Res. 1998;29:154-155.
4. Vieta E, Mullen J, Brecher M, et al. Quetiapine monotherapy for mania associated with bipolar disorder: combined analysis of two international, double-blind, randomised, placebo-controlled studies. Curr Med Res Opin. 2005;21:923-934.
5. Calabrese JR, Keck Jr. PE, 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.
6. Thase ME, Macfadden W, Weisler RH, et al. Efficacy of quetiapine monotherapy in bipolar I and II depression: a double-blind, placebo-controlled study (the BOLDER II study). J Clin Psychopharmacol. 2006;26:600-609.
7. Perkins DO. Adherence to antipsychotic medications. J Clin Psychiatry. 1999;60(Suppl 21):25-30.
8. Byerly MJ, Nakonezny PA, Lescouflair E. Antipsychotic medication adherence in schizophrenia. Psychiatr Clin North Am. 2007;30:437-452.
9. Valenstein M, Ganoczy D, McCarthy JF, et al. Antipsychotic adherence over time among patients receiving treatment for schizophrenia: a retrospective review. J Clin Psychiatry. 2006;67:1542-1550.
10. Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med. 2005;353:1209-1223.
11. Leucht S, Heres S. Epidemiology, clinical consequences, and psychosocial treatment of nonadherence in schizophrenia. J Clin Psychiatry. 2006;67(Suppl 5):3-8.
12. Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005;353:487-497.
13. Suppes T, Earley W, Datto C, et al. Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar depression. Int J Neuropsychopharmacol. 2008;11.
14. Cutler A, Earley W, Datto C, et al. Effectiveness of the extended release formulation of quetiapine as monotherapy for the treatment of acute bipolar mania. Int J Neuropsychopharmacol. 2008;11.
15. Kahn RS, Schulz SC, Palazov VD, et al. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007;68:832-842.
16. Bell MD, Lysaker PH, Beam-Goulet JL, et al. Five-component model of schizophrenia: assessing the factorial invariance of the positive and negative syndrome scale. Psychiatry Res. 1994;52:295-303.
17. Emsley RA, Buckley P, Jones AM, et al. Differential effect of quetiapine on depressive symptoms in patients with partially responsive schizophrenia. J Psychopharmacol. 2003;17:210-215.
18. Kane JM, Carson WH, Saha AR, et al. Efficacy and safety of aripiprazole and haloperidol versus placebo in patients with schizophrenia and schizoaffective disorder. J Clin Psychiatry. 2002;63:763-771.
19. Lieberman J, Carson WH, Saha A, et al. Meta-analysis of the efficacy of aripiprazole in schizophrenia. Int J Neuropsychopharmacol. 2002;5(Suppl 1):S186.
20. Potkin SG, Saha AR, Kujawa MJ, et al. Aripiprazole, an antipsychotic with a novel mechanism of action, and risperidone vs placebo in patients with schizophrenia and schizoaffective disorder. Arch Gen Psychiatry. 2003;60:681-690.
21. Hommel G. A stagewise rejective multiple test procedure based on a modified Bonferroni test. Biometrika. 1988;75:383-386.
22. Kobak KA, Lipsitz JD, Williams JB, et al. A new approach to rater training and certification in a multicenter clinical trial. J Clin Psychopharmacol. 2005;25:407-412.
23. Krell HV, Leuchter AF, Morgan M, et al. Subject expectations of treatment effectiveness and outcome of treatment with an experimental antidepressant. J Clin Psychiatry. 2004;65:1174-1179.
24. Copolov DL, Link CGG, Kowalcyk B. A multicentre, double-blind, randomized comparison of quetiapine (ICI 204,636, 'Seroquel') and haloperidol in schizophrenia. Psychol Med. 2000;30:95-105.
25. Tandon R, Jibson MD. Comparing efficacy of first-line atypical antipsychotics: no evidence of differential efficacy between risperidone, olanzapine, quetiapine, ziprasidone, and aripiprazole. Int J Psychiatry Clin Pract. 2005;9:204-212.
26. AstraZeneca data on file. Seroquel DOF number 9049. 2008.
27. Peuskens J, Trivedi JK, Malyarov S, et al. Prevention of schizophrenia relapse with extended release quetiapine fumarate dosed once daily: a randomized placebo-controlled trial in clinically stable patients. Psychiatry (Edgemont). 2007;4:34-50.
28. Laughren TP. The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective. Eur Psychiatry. 2001;16:418-423.
29. Kemmler G, Hummer M, Widschwendter C, et al. Dropout rates in placebo-controlled and activecontrol clinical trials of antipsychotic drugs: a meta-analysis. Arch Gen Psychiatry. 2005;62:1305-1312.
30. Cutler AJ, Kalali AH, Weiden PJ, et al. Four-week, double-blind, placebo- and ziprasidone-controlled trial of iloperidone in patients with acute exacerbations of schizophrenia. J Clin Psychopharmacol. 2008;28:S20-S28.
31. Narayan S, Tang B, Head SR, et al. Molecular profiles of schizophrenia in the CNS at different stages of illness. Brain Res. 2008.
32. Ganguly R, Kotzan JA, Miller LS, et al. Prevalence, trends, and factors associated with antipsychotic polypharmacy among Medicaid-eligible schizophrenia patients, 1998-2000. J Clin Psychiatry. 2004;65:1377-1388.
33. Khanna S, Vieta E, Lyons B, et al. Risperidone in the treatment of acute mania: double-blind, placebocontrolled study. Br J Psychiatry. 2005;187:229-234.
34. Khan A, Bhat A. Is the problem of a high placebo response unique to antidepressant trials? J Clin Psychiatry. 2008;69:1979-1980.
35. Mullen J, Jibson MD, Sweitzer D, et al. A comparison of the relative safety, efficacy, and tolerability of quetiapine and risperidone in outpatients with schizophrenia and other psychotic disorders: the Quetiapine Experience with Safety and Tolerability (QUEST) study. Clin Ther. 2001;23:1839-1854.
36. Timdahl K, Carlsson A, Stening G. An analysis of safety and tolerability data from controlled, comparative studies of quetiapine in patients with schizophrenia, focusing on extrapyramidal symptoms. Hum Psychopharmacol. 2007;22:315-325