Lessons learned in the conduct of a global, large simple trial of treatments indicated for schizophrenia

Contemporary Clinical Trials

Volumn 34, Issue 2, 2013, Pages 239-247

  Kolitsopoulos, Francesca M ^a   Strom, Brian L ^b   Faich, Gerald ^c   Eng, Sybil M ^a   Kane, John M ^d   Reynolds, Robert F ^a  

^a PFIZER INC   (United States)

^b UNIVERSITY OF PENNSYLVANIA   (United States)

^c UNITED BIOSOURCE CORPORATION   (United States)

^d Feinstein Institute of Medical Research Northshore Long Island Jewish Health System   (United States)

Author keywords

Large simple trial; Recruitment; Retention; Schizophrenia; Ziprasidone; ZODIAC

Indexed keywords

OLANZAPINE; ZIPRASIDONE;

ARTICLE; ASIA; CLINICAL ASSESSMENT TOOL; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); CONTRACT RESEARCH ORGANIZATION; CONTROLLED STUDY; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; EUROPE; FOLLOW UP; HEALTH CARE ORGANIZATION; HUMAN; HYPERGLYCEMIA; LARGE SIMPLE TRIAL; MAJOR CLINICAL STUDY; MENTAL PATIENT; MORTALITY; MULTICENTER STUDY; NATIONAL DEATH INDEX; NORTH AMERICA; OBSERVATIONAL STUDY; OPEN STUDY; PSYCHIATRY; RANDOMIZED CONTROLLED TRIAL; RISK BENEFIT ANALYSIS; SCHIZOPHRENIA; SIDE EFFECT; SOUTH AMERICA; TREATMENT DURATION; TREATMENT INDICATION; WEIGHT GAIN;

ANTIPSYCHOTIC AGENTS; BENZODIAZEPINES; CAUSE OF DEATH; HUMANS; INTERNATIONAL COOPERATION; LONGITUDINAL STUDIES; LOST TO FOLLOW-UP; PATIENT SELECTION; PIPERAZINES; RESEARCH DESIGN; SCHIZOPHRENIA; THIAZOLES;

EID: 84871784192     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2012.12.001     Document Type: Article

References (36)

1. Rationale, design, implementation, and baseline characteristics of patients in the DIG trial: a large, simple, long-term trial to evaluate the effect of digitalis on mortality in heart failure. Control Clin Trials 1996, 17(1):77-97.
2. Horsburgh C.R. A large, simple trial of a tuberculosis vaccine. Clin Infect Dis 2000, 30(Suppl. 3):S213-S216.
3. March J.S., Silva S.G., Compton S., Anthony G., DeVeaugh-Geiss J., Califf R., et al. The child and adolescent psychiatry trials network (CAPTN). J Am Acad Child Adolesc Psychiatry 2004, 43(5):515-518.
4. Peto R., Collins R., Gray R. Large-scale randomized evidence: large, simple trials and overviews of trials. Ann N Y Acad Sci 1993, 703:314-340.
5. Reynolds R.F., Lem J.A., Gatto N.M., Eng S.M. Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature. Drug Saf 2011, 34(10):799-820.
6. Yusuf S., Collins R., Peto R. Why do we need some large, simple randomized trials?. Stat Med 1984, 3(4):409-422.
7. Yusuf S., Mehta S.R., Diaz R., Paolasso E., Pais P., Xavier D., et al. Challenges in the conduct of large simple trials of important generic questions in resource-poor settings: the CREATE and ECLA trial program evaluating GIK (glucose, insulin and potassium) and low-molecular-weight heparin in acute myocardial infarction. Am Heart J 2004, 148(6):1068-1078.
8. Geddes J., Goodwin G. Bipolar disorder: clinical uncertainty, evidence-based medicine and large-scale randomised trials. Br J Psychiatry Suppl 2001, 41:s191-s194.
9. March J.S., Silva S.G., Compton S., Shapiro M., Califf R., Krishnan R. The case for practical clinical trials in psychiatry. Am J Psychiatry 2005, 162(5):836-846.
10. Geddes J.R., Rendell J.M., Goodwin G.M. BALANCE: a large simple trial of maintenance treatment for bipolar disorder. World Psychiatry 2002, 1(1):48-51.
11. Ismail M.S., Dagerman K., Tariot P.N., Abbott S., Kavanagh S., Schneider L.S. National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness-Alzheimer's Disease (CATIE-AD): baseline characteristics. Curr Alzheimer Res 2007, 4(3):325-335.
12. Baldessarini R.J. Commentary: the Bipolar Affective Disorder: Lithium/Anticonvulsant Evaluation (BALANCE) study. Bipolar Disord 2010, 12(7):669-672.
13. Brooks J.O., Goldberg J.F., Ketter T.A., Miklowitz D.J., Calabrese J.R., Bowden C.L., et al. Safety and tolerability associated with second-generation antipsychotic polytherapy in bipolar disorder: findings from the Systematic Treatment Enhancement Program for Bipolar Disorder. J Clin Psychiatry 2011, 72(2):240-247.
14. Sachs G.S., Thase M.E., Otto M.W., Bauer M., Miklowitz D., Wisniewski S.R., et al. Rationale, design, and methods of the systematic treatment enhancement program for bipolar disorder (STEP-BD). Biol Psychiatry 2003, 53(11):1028-1042.
15. Lieberman J.A., Stroup T.S., McEvoy J.P., Swartz M.S., Rosenheck R.A., Perkins D.O., et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia. N Engl J Med 2005, 353(12):1209-1223.
16. Meltzer H.Y. Suicide and schizophrenia: clozapine and the InterSePT study. International Clozaril/Leponex Suicide Prevention Trial. J Clin Psychiatry 1999, 60(Suppl. 12):47-50.
17. Meltzer H.Y., Alphs L., Green A.I., Altamura A.C., Anand R., Bertoldi A., et al. Clozapine treatment for suicidality in schizophrenia: International Suicide Prevention Trial (InterSePT). Arch Gen Psychiatry 2003, 60(1):82-91.
18. Schneider L.S., Tariot P.N., Lyketsos C.G., Dagerman K.S., Davis K.L., Davis S., et al. National Institute of Mental Health Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE): Alzheimer disease trial methodology. Am J Geriatr Psychiatry 2001, 9(4):346-360.
19. Strom B.L., Eng S.M., Faich G., Reynolds R.F., D'Agostino R.B., Ruskin J., et al. Comparative mortality associated with ziprasidone and olanzapine in real-world use among 18,154 patients with schizophrenia: The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC). Am J Psychiatry 2010, 168(2):193-201.
20. Strom B.L., Faich G.A., Reynolds R.F., Eng S.M., D'Agostino R.B., Ruskin J.N., et al. The Ziprasidone Observational Study of Cardiac Outcomes (ZODIAC): design and baseline subject characteristics. J Clin Psychiatry 2008, 69(1):114-121.
21. Geier J.L., Karayal O.N., Lewis M., Camm J.A., Keane M., Kremer C.M., et al. Methodological challenges in the coding and adjudication of sudden deaths in a large simple trial with observational follow-up: the ziprasidone observational study of cardiac outcomes (ZODIAC). Pharmacoepidemiol Drug Saf 2011, 20(11):1192-1198.
22. Fischer E.H., Dornelas E.A., Goethe J.W. Characteristics of people lost to attrition in psychiatric follow-up studies. J Nerv Ment Dis 2001, 189(1):49-55.
23. Patel M.X., Doku V., Tennakoon L. Challenges in recruitment of research participants. Adv Psychiatr Treat 2003, 9:229-238.
24. Woodall A., Morgan C., Sloan C., Howard L. Barriers to participation in mental health research: are there specific gender, ethnicity and age related barriers?. BMC Psychiatry 2010, 10(103).
25. Roberts L.W., Warner T.D., Anderson C.T., Smithpeter M.V., Rogers M.K. Schizophrenia research participants' responses to protocol safeguards: recruitment, consent, and debriefing. Schizophr Res 2004, 67(2-3):283-291.
26. Loue S., Sajatovic M. Research with severely mentally ill Latinas: successful recruitment and retention strategies. J Immigr Minor Health 2008, 10(2):145-153.
27. Kaminsky A., Roberts L.W., Brody J.L. Influences upon willingness to participate in schizophrenia research: an analysis of narrative data from 63 people with schizophrenia. Ethics Behav 2003, 13(3):279-302.
28. Coen A.S., Patrick D.C., Shern D.L. Minimizing attrition in longitudinal studies of special populations: an integrated management approach. Eval Program Plann 1996, 19(4):309-319.
29. Ashery R.S., McAuliffe W.E. Implementation issues and techniques in randomized trials of outpatient psychosocial treatments for drug abusers: recruitment of subjects. Am J Drug Alcohol Abuse 1992, 18(3):305-329.
30. Furedi J., Mohr P., Swingler D., Bitter I., Gheorghe M.D., Hotujac L., et al. Psychiatry in selected countries of Central and Eastern Europe: an overview of the current situation. Acta Psychiatr Scand 2006, 114(4):223-231.
31. Mateus M.D., Mari J.J., Delgado P.G., Almeida-Filho N., Barrett T., Gerolin J., et al. The mental health system in Brazil: policies and future challenges. Int J Ment Health Syst 2008, 2(1):12.
32. Rybakowski J.K. Academic psychiatry in Poland: adjustment to rapid changes. Mol Psychiatry 2004, 9(9):813-815.
33. Gianfrancesco F.D., Grogg A.L., Mahmoud R.A., Wang R.H., Nasrallah H.A.. Differential effects of risperidone, olanzapine, clozapine, and conventional antipsychotics on type 2 diabetes: findings from a large health plan database. J Clin Psychiatry 2002, 63(10):920-930.
34. Koro C.E., Fedder D.O., L'Italien G.J., Weiss S.S., Magder L.S., Kreyenbuhl J., et al. Assessment of independent effect of olanzapine and risperidone on risk of diabetes among patients with schizophrenia: population based nested case-control study. BMJ 2002, 325(7358):243.
35. Warning about hyperglycemia and atypical antipsychotic drugs United States Food and Drug Administration, [cited 22June2012]; Available from: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/printer.cfm?id=229.
36. Egan D., Geller N., Yusuf S., Garg R., Collins J.F., Mathew J., et al. Lessons learned from the DIG trial. Control Clin Trials 2003, 24(6 Suppl.):316S-326S.