306 18. Therapeutics: Treatment Trials in patients with schizophrenia. Schizophrenia patients have a high- er rate of smoking than the general population and are less likely to receive smoking cessation interventions. Following several positive studies, buproprion HC1, initially marketed as the antidepressant Wellbutrin, received FDA approval for smoking cessation. We per- formed an open labeled study in patients with schizophrenia, and found that though no one quit smoking, treatment with bupropion SR was associated with a decrease in cigarette consumption, as meas- ured by a change in CO levels (mean CO at baseline was 39.44+/- 21.30 and at end of study was 18.38+/-11.96, representing a mean change (+/-SD) of 21.06+/-22.25 (t=-2.68; df=7; p 0.05). There were no adverse effects on positive, depressive, or anxiety symptoms. The decrease in cigarette consumption began prior to the initiation of bupropion SR and prior to quit day and then stabilized after treat- ment week four. The early reduced consumption may possibly be due to the group therapy itself and/or heightened attention of the sub- jects toward smoking cessation. To clarify these issues, we are cur- rently conducting a double-blind study with forty patients with a DSM-IV Schizophrenia/Schizoaffective disorder who smoke at least a half pack a day and rate "moderate" on the Nicotine Dependency Test. Following a two week lead-in phase, subjects begin a 9 session support group and 2 weeks later are randomly assigned to either bupropion SR or placebo, in addition to their usual medications. Study medication is given for 12 weeks, and nicotine replacement in the form of Nicorette gum is available for subjects' usage. The main outcome measure, cigarette consumption, will be assessed through measurement of end expired carbon monoxide levels, urinary coti- nine levels, and the Fagerstom Test for Nicotine Dependence. Symp- tom rating, motivational assessments and cognitive measures will be obtained intermittently throughout the study. The primary analytic approach will use repeated measures ANCOVA, with adjustment for baseline expired CO level, with treatment assignment as the between group factor and expired CO level as the repeated measure. A VIDEOTAPE INTERVENTION TO ENHANCE THE INFORMED CONSENT PROCESS FOR PATIENTS PARTICIPATING IN CLINICAL RESEARCH TRIALS D. A. Wirshing,* J. Mintz, R. Kern, J. Boyd Psychiatry, UCLA School of Medicine, Los Angeles, CA, USA OBJECTIVE: The ability of patients with schizophrenia to give informed consent for participation in clinical trials research has been a subject of some scrutiny. Indeed, the ability of patients without mental illness to fully appreciate the implications of research partic- ipation may also need improvement. The goal of this project is to develop an educational intervention that enhances patients' partici- pation and understanding of the informed consent process. METH- ODS: Schizophrenia patients considering participation in clinical tri- als and medical patients awaiting appointments(not necessarily in research protocols) were randomly assigned to view one of two videotapes. One of the videos ("experimental") teaches about the informed consent process, covering participant and investigator responsibilities, typical content of informed consent in treatment research and elements of good decision making, and to encourage active participation in the consent process. The other video ("con- trol") had no specifics about the informed consent process itself, instead presenting information on the history of the issues of human subject protection and the regulatory apparatus including IRBs. Both videos take about 15 minutes. An eighty item true and false quiz about the informed consent procedure was administered before and after viewing the videos. RESULTS: Seventy-eight schizophrenia patients have viewed the videos (43 viewed the experimental video and 35 tile control video). 83 medical patients (some with self-report- ed psychiatric comorbidities) viewed the experimental teaching video and 39 viewed the control video. Schizophrenia patients who viewed the experimental tape improved more in knowledge of the consent process than those viewing the control tape (t=4.01, df=69.5, p=0.0002). A similar result was obtained among medical patients (t--3.88, df=120, p=.0002). Those viewing the experimental tape showed greater increases in knowledge of the IC process than those viewing the control video, whether they reported co-morbid psychi- atric illness (t=2.5, df=58, p=.02) or not (t=3.07, df=58.8, p=.003). CONCLUSIONS: These results suggest that an educational video- tape increases knowledge of the informed consent process among schizophrenia patients who are actively considering treatment research participation as well as among medical patients who are not being recruited for research. The intervention is simple to use and can readily be integrated into any clinical trial. OLANZAPINE VERSUS PLACEBO FOR PRODROMAL SYMPTOMS S. W. Woods,* A. Breier, R. B. Zipursky, D. O. Perkins, J. Addington, T. J. Miller, K. A. Hawkins, E. Marquez, S. R. Lindborg, M. Tohen, T. H. McGlashan Psychiatry, Yale Sch. Med. and VA CT West Haven, West Haven, CT, USA The prodromal phase of schizophrenic disorders has recently been prospectively characterized, and intervention research has begun. No studies, however, have yet focused on determining whether treatment improves the current symptoms of the patients or employed a place- bo control. The purpose of the present study was to determine the short-term efficacy and safety of olanzapine treatment of prodromal symptoms compared to placebo. Methods. The study was a double- blind, randomized, parallel-groups, placebo-controlled trial with fixed-flexible dosing at 4 academic PRIME prodromal research clin- ics in North America. The sample consisted of 60 referred patients meeting prodromal diagnostic criteria as determined by the Struc- tured Interview for Prodromal Syndromes (mean age 17.7 yrs, 65% male, 67% Caucasian). Eleven additional patients consented but were not randomized. Assigned treatments were olanzapine 5-15 mg vs placebo by mouth once daily for 8 weeks. Individual and family sup- portive psychotherapy was available to all patients. The primary out- come measure was change from baseline on Scale of Prodromal Symptoms (SOPS) total score. Results. Prescribed average daily dos- es were 8.0 mg/d for olanzapine and 9.3 "mg"/d for placebo. Aver- age adherence with prescribed doses was 87.8% for olanzapine treat- ed patients and 89.3% for placebo. In the mixed effects repeated measures analysis, the treatment-by-time interaction for the SOPS total score change from baseline was statistically significant, and post-hoc analyses revealed a trend toward improvement from base- line in the olanzapine group at the third week and significant improvement by the fourth week, but no significant change in the placebo group at any time-point. The olanzapine-placebo difference reached p<.10 by week 6 and p<.05 at week 8. One patient in each group was withdrawn for adverse events. Ratings of extrapyramidal symptoms (EPS) remained low in each group and were not signifi- cantly different. Olanzapine patients gained 9.9+/-14.6 lb compared to 0.7+/-5.9 tb for placebo patients (p<.001). Conclusions. This short- term analysis suggests olanzapine is associated with significantly greater symptomatic improvement but significantly greater weight gain than placebo in prodromal patients. EPS with olanzapine was International Congress on Schizophrenia Research 2003