Veteran Subjects Willingness to Participate in Schizophrenia Clinical Trials
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Predictive characteristics of subjects agreeing to be randomized into clinical trials for the treatment of schizophrenia and schizoaffective disorder have been little studied. In this study, we used data from the recruitment phase of a randomized trial that compared long acting injectable (LAI) risperidone to oral antipsychotic medications. Basic socio-demographic and clinical data were gathered from eligible patients and clinicians at the time of screening for trial entry. Bivariate comparisons and multivariate logistic regression were used to compare those who agreed to participate and those who refused. Altogether 446 veterans were eligible on preliminary screening, of these 382 (86 %) agreed to participate and 64 (14 %) declined. Eligible patients who agreed to be randomized were more willing to change medications without regard to their level of satisfaction with their current medication. Subjects reported as currently taking LAI medication and taking risperidone, in particular, were more likely to agree to participate. Factors that did not significantly predict participation included age, years on current medication, reported medication compliance, race, and gender. Veterans with schizophrenia or schizoaffective disorder who were actually more satisfied with their current medications and who were currently taking the experimental agent were more likely to agree to participate in this randomized clinical trial in contrast to expectations that individuals who are unsatisfied with their current treatment would be more likely to enroll in such studies.
- Haddad PM, Taylor M, Niaz OS: First-generation antipsychotic long-acting injections v. oral antipsychotics in schizophrenia: Systematic review of randomised controlled trials and observational studies. British Journal of Psychiatry Supplement 52:S20–S28, 2009. CrossRef
- Hamer S, Haddad PM: Adverse effects of antipsychotics as outcome measures. British Journal of Psychiatry Supplement 50:s64–s70, 2007. CrossRef
- Bowen, J, Hirsch, S: Recruitment rates and factors affecting recruitment for a clinical trial of a putative anti-psychotic agent in the treatment of acute schizophrenia. Human Psychopharmacology 7:337–341, 1992. CrossRef
- Robinson D, Woerner MG, Pollack S, Lerner G: Subject selection biases in clinical trials: data from a multicenter schizophrenia treatment study. Journal of Clinical Psychopharmacology 16:170–176, 1996. CrossRef
- Hofer A, Hummer M, Huber R, Kurz M, Walch T, Fleischhacker WW: Selection bias in clinical trials with antipsychotics. Journal of Clinical Psychopharmacology 20:699–702, 2000. CrossRef
- Barnett PG, Scott JY, Rosenheck RA, CSP 555 Study Group: How do clinical trial participants compare to other patients with schizophrenia? Schizophrenia Research 130:34–39, 2011. CrossRef
- Rosenheck R, Leslie D, Sernyak M: From clinical trials to real-world practice: Use of atypical antipsychotic medication nationally in the Department of Veterans Affairs. Medical Care 39: 302–308, 2001. CrossRef
- Rosenheck RA, Leslie DL, Sindelar J, et al. Cost-effectiveness of second-generation antipsychotics and perphenazine in a randomized trial of treatment for chronic schizophrenia. American Journal of Psychiatry 163:2080–2089, 2006. CrossRef
- Rosenheck RA, Krystal JH, Lew R, et al.: Challenges in the design and conduct of controlled clinical effectiveness trials in schizophrenia. Clinical Trials 8:196–204, 2011. CrossRef
- Rosenheck RA, Krystal JH, Lew R, et al.: Long-acting risperidone and oral antipsychotics in unstable schizophrenia. New England Journal of Medicine 364:842–851, 2011. CrossRef
- Appelbaum PS, Grisso T. MacArthur competence assessment tool for clinical research (MacCAT-CR). Sarasota: Professional Resource Press/Professional Resource Exchange, 2001.
- Keith SJ: Evaluating characteristics of patient selection and dropout rates. Journal of Clinical Psychiatry 62 (Suppl 9):11–14, 2001.
- Khan AY, Preskorn SH, Baker B: Effect of study criteria on recruitment and generalizability of the results. Journal of Clinical Psychopharmacology 25:271–275, 2005. CrossRef
- Lewis SW, Davies L, Jones PB, et al.: Randomised controlled trials of conventional antipsychotic versus new atypical drugs, and new atypical drugs versus clozapine, in people with schizophrenia responding poorly to, or intolerant of, current drug treatment. Health Technology Assessment 10: iii–iv, ix–xi, 1–165, 2006.
- Ascher-Svanum H, Peng X, Faries D, Montgomery W, Haddad PM: Treatment patterns and clinical characteristics prior to initiating depot typical antipsychotics for nonadherent schizophrenia patients. BMC Psychiatry: 9:46, 2009. CrossRef
- Essock SM, Covell NH, Davis SM, Stroup TS, Rosenheck RA, Lieberman JA: Effectiveness of switching antipsychotic medications. American Journal of Psychiatry 163:2090–2095, 2006. CrossRef
- Schooler NR: The statistical comparison of clinical trials. Journal of Clinical Psychiatry 62 (Suppl 9):35–37, 2001.
- Chaves AC, Seeman MV: Sex selection bias in schizophrenia antipsychotic trials. Journal of Clinical Psychopharmacology 26:489–494, 2006. CrossRef
- Woods SW, Gueorguieva RV, Baker CB, Makuch RW: Control group bias in randomized atypical antipsychotic medication trials for schizophrenia. Archives of General Psychiatry 62:961–970, 2005. CrossRef
- Mohr P, Czobor P: Subject selection for the placebo- and comparator-controlled trials of neuroleptics in schizophrenia. Journal of Clinical Psychopharmacology 20:240–245, 2000. CrossRef
- Docherty JP: Interpretations and conclusions in the clinical trial. Journal of Clinical Psychiatry 62 (Suppl 9):40–43, 2001.
- Casey DE: Clinical trial design issues in schizophrenic research. Journal of Clinical Psychiatry 62 (Suppl 9):17–20, 2001.
- Schooler NR: New antipsychotic medications: strategies for evaluation and selected findings. Schizophrenia Research 27:249–259, 1997. CrossRef
- Riedel M, Strassnig M, Müller N, Zwack P, Möller HJ. How representative of everyday clinical populations are schizophrenia patients enrolled in clinical trials? European Archives of Psychiatry and Clinical Neuroscience 255:143–148, 2005. CrossRef
- Reyes JF, Preskorn SH, Khan A, et al.: Concurrent administration of donepezil HCl and risperidone in patients with schizophrenia: assessment of pharmacokinetic changes and safety following multiple oral doses. British Journal of Clinical Pharmacology 58 (Suppl 1):50–57, 2004. CrossRef
- Edlund MJ, Craig TJ, Richardson MA: Informed consent as a form of volunteer bias. American Journal of Psychiatry 142: 624–627, 1985.
- Jaskiw GE, Blumer TE, Gutierrez-Esteinou R, Meltzer HY, Steele V, Strauss ME: Comparison of inpatients with major mental illness who do and do not consent to low-risk research. Psychiatry Research 119:183–188, 2003. CrossRef
- Kemp AS, Schooler NR, Kalali AH, et al. What is causing the reduced drug-placebo difference in recent schizophrenia clinical trials and what can be done about it? Schizophrenia Bulletin 36:504–509, 2010. CrossRef
- Hasler G, Moergeli H, Bachmann R, Lambreva E, Buddeberg C, Schnyder U: Patient satisfaction with outpatient psychiatric treatment: the role of diagnosis, pharmacotherapy, and perceived therapeutic change. Canadian Journal of Psychiatry 49:315–321, 2004.
- Thornicroft G, Tansella M, Becker T, et al.: The personal impact of schizophrenia in Europe. Schizophrenia Research 69:125–132, 2004. CrossRef
- Veteran Subjects Willingness to Participate in Schizophrenia Clinical Trials
Volume 84, Issue 2 , pp 209-218
- Cover Date
- Print ISSN
- Online ISSN
- Springer US
- Additional Links
- Schizoaffective disorder
- Clinical trials
- Author Affiliations
- 1. Inpatient Mental Health Services, Palo Alto Veterans Affairs Health Care System, Mail Code 118 j, 3801 Miranda Ave, Palo Alto, CA, 94304, USA
- 2. Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA
- 3. Department of Psychiatry, Yale University, New Haven, CT, USA
- 4. Veterans Affairs New England Mental Illness, Research Education and Clinical Center, VA Connecticut Health Care System, West Haven, CT, USA
- 5. Massachusetts Veterans Epidemiology and Research Information Center, VA Cooperative Studies Coordinating Center, Boston, MA, USA