Long-term treatment of schizophrenia2
1-year, fixed-dose, placebo-controlled study
  • Probability of relapse at 1 year was significantly lower with GEODON vs placebo (P<0.05)
STUDY DESCRIPTION: GEODON vs placebo (1-year schizophrenia study) 2
Results from a prospective, 1-year, double-blind, placebo-controlled, multicenter study of 294 patients with chronic stable schizophrenia (DSM-III-R) hospitalized for at least 2 months. Prior to enrollment, patients were withdrawn from antipsychotic and anticholinergic medication over a 3-day, single-blind, placebo run-in period. Patients were then randomized to receive either GEODON 40 mg/day, 80 mg/day, or 160 mg/day, or placebo for 1 year. Primary efficacy end point was time to and rate of impending relapse, as defined by a CGI-I score of ≥6 or a score of ≥6 on PANSS items P7 (hostility) or G8 (uncooperativeness) persisting for 2 successive days. Patients with a CGI-I score of 5 (minimally worse) were continually monitored until the score either improved (patients remained in study) or deteriorated to ≥6 (much worse or very much worse; patients were withdrawn from the study). Secondary end points included the Global Assessment of Functioning (GAF) scale administered at 28 and 52 weeks. Patients were weighed at baseline and at Weeks 28 and 52. Patients were immediately withdrawn and treated openly if they reached the end point of impending relapse.