Treatment outcome in patients with chronic schizophrenia during long-term administration with risperidone.

Treatment outcome was evaluated in outpatients with chronic schizophrenia during long-term administration of risperidone in a study reflecting clinical practice. This UK multicenter, noncomparative, open trial was conducted in 79 patients. Risperidone treatment for 52 weeks commenced at 2 mg/d, with the option to titrate to 6 mg/d. The primary efficacy variable was study failure (study discontinuation for relapse, adverse events, insufficient response, withdrawn consent, lost to follow-up, or noncompliance). The most common dosage was 6 mg/d. Of the 79 patients in the intent-to-treat analysis, 38 completed the study (sustained treatment success), 29 were classified as treatment failure, and 12 were "not evaluable." When the intent-to-treat population was reclassified into study success or study failure, there were 40 study successes (38 treatment successes and 2 ineligible to continue) and 39 study failures (29 treatment failures, 3 lost to follow-up, and 7 noncompliant). Among patients considered to be treatment failures, only 10 had relapse and 10 had adverse events, 2 had insufficient response, and 7 withdrew consent. Raw mean time to treatment failure was 101.7 +/- 90.9 days, and median time was 77 days (range 7 to 284). From Kaplan-Meier curves, mean time to treatment failure was 213.3 +/- 12.2 days; the median was longer than the study period. There was significant improvement (reduction in severity of symptoms) for the intent-to-treat population in total and all Positive and Negative Syndrome Scale subscale scores (P < or =0.0119), Clinical Global Impression Severity (P = 0.0003), cognitive function "letter fluency totals" (P = 0.0044), Abnormal Involuntary Movement Scale (P < 0.0001), and Targeting Abnormal Kinetic Effects scale (measures abnormal kinetic effects; P < 0.0001) at study end point. Most patients considered the treatment at least "acceptable" during the study, and mean change at study end corresponded to between "acceptable" and "quite acceptable." After 1 year of risperidone treatment in a naturalistic setting reflecting usual UK clinical practice, patients with chronic schizophrenia showed improvement in symptoms and reduction in disease severity, and only 10 of 79 had relapse; 48.1% of patients were considered to be sustained treatment successes, 36.7% as treatment failures, and 15.2% as not "evaluable." Fifty-one percent of patients were considered to be study successes and 49% as study failures.