ISSUES IN RECRUITMENT OF ELDERLY PATIENTS FOR ANTIPSYCHOTIC DRUG STUDIES

Am J Geriatr Psychiatry Supplement, Fall 1999 53 “PREDICTORS” OF LIVING SITUATIONS IN OLDER PATIENTS WITH SCHIZOPHRENIA. Nita Paintal, M.D.; Thomas L. Patterson, Ph.D.; Sherry Moscona; Dilip V. Jeste, M.D. Introduction: Several studies in younger adults with schizophrenia have shown that living with someone, either parent or spouse, is associated with better functional outcome and fewer negative symptoms. There have, however, been few such studies in older subjects. Methods: The authors examined the living situation in 142 middle-age and elderly outpatients diagnosed with schizophrenia: 36 of these lived alone, 65 lived with someone, and 41 patients lived in board-and-care homes or skilled nursing facility (SNF). The authors evaluated “predictors” of living situation in terms of demographics including age, race, gender, education years and duration of illness; psychopathology assessed with Scale for Assessment of Negative Symptoms (SANS), Scale for Assessment of Positive Symptoms (SAPS) and Ham-D; and cognitive impairment assessed with Dementia Rating Scale (DRS) and MMSE. Results: Patients who lived in board-and-care homes or SNF had significantly (P 0.05) lower scores on MMSE and DRS and higher scores on SANS and higher daily neuroleptic dose. Interestingly, there was no significant difference on any of the measures examined between those who lived alone and those who lived with someone. Conclusions: These results are partly, but not entirely, similar to the published findings in younger patients with schizophrenia. Longitudinal studies are necessary to determine the prognostic factors for schizophrenia in old age. Such studies will have clinical as well as health services implications. P65 RISPERIDONE IN THE TREATMENT OF CHOREOATHETOSIS IN PATIENTS WITH HUNTINGTON’S DISEASE. Mahmoud A. Parsa, M.D.; Heather Greenaway, R.N.; University Hospitals, Case Western Reserve University, Cleveland, Ohio Introduction: Huntington’s disease (HD) is an autosomal dominant inherited disease distinguished by caudate atrophy, choreoathetosis, dementia, and psychiatric disturbances. No cure is yet available for HD, but dopaminergic blockade by neuroleptic drugs may sometimes ameliorate both motor and mental abnormalities. Risperidone is a novel antipsychotic agent with a balanced serotonin 5-HT2 and dopamine D2 receptor antagonism. Objective: This study was intended to evaluate the utility of risperidone in the treatment of motor abnormalities in HD. Method: Five HD patients (one man and four women age 47–85 years) with moderate to severe choreoathetosis were treatedwith risperidone. Risperidone was started at 0.5 mg/day and gradually increased based on clinical response and tolerability. Final dosages ranged from 1.5 mg/day to 7.5 mg/day and sustained for a period of 2–6 months. The Abnormal Involuntary Movement Scale (AIMS) and the Marsden and Quinn Chorea Evaluation Scale measured the severity of motor disability at baseline and during treatment with risperidone. Cognitive status was assessed by means of the MMSE. Results: In all the patients, choreoathetoid movements reduced dramatically, with an average improvement of 65.1% on AIMS scores and an average improvement of 56.2% on Marsden and Quinn Chorea Evaluation Scale scores. MMSE evaluation of cognitive status at baseline and after treatments with maximum effective/tolerated dosage of risperidone demonstrated no significant changes in mean scores. Conclusion: This study demonstrates that risperidone may be an effective medication in controlling choreoathetosis in patients with HD. Further studies of larger populations are needed to confirm these preliminary findings. P13 ISSUES IN RECRUITMENT OF ELDERLY PATIENTS FOR ANTIPSYCHOTIC DRUG STUDIES. Mihaela Petersen, M.D.; Hoang Nguyen, M.D.; Kelly Harless, B.A.; Dina Polichar, M.Ed.; Helen Vanderswag, R.N.; Jody DelaPena, B.S.; Dilip V. Jeste, M.D. Introduction: There has been an increasing number of industry-sponsored drug studies in elderly patients during the past few years. There is thus a need to examine factors associated with recruitment of such patients. Methods: The authors are participating in two phase-IV multicenter industry-sponsored studies of atypical antipsychotic drugs. Of the first 177 patient screened for these studies, only 7 met the study criteria and were recruited. The authors examined the reasons for exclusion of the remaining 170 patients. Results: The “usual” reasons such as inappropriate diagnosis (11.9%), insufficient severity of illness (7.9%), refusal to participate (6.2%), etc., accounted for a majority of exclusions. However, reasons of specific note from the viewpoint of generalizability of findings included the following: being on “disallowed” medications such as antidepressants (22.5%), current substance abuse (4.5%), and medical comorbidity that was “not permissible” in the study (4.4%). The authors present data showing the possible impact of these exclusions on representativeness of study results. Comments: Study design dictated by regulatory concerns may affect generalizability of the results of clinical trials, especially in elderly patients. P70