A total of 16 subjects were enrolled in the study. Of these, five were prodromal patients (mean age=15.6 years, SD=0.8; three boys and two girls), four of whom completed the trial, and 11 were first-episode patients (mean age=23.9 years, SD=5.5; eight men and three women), six of whom completed the trial. The mean dose of risperidone was 1.04 mg/day (SD=0.12) among prodromal patients and 1.83 mg/day (SD=0.50) among first-episode patients. Adverse events judged to be possibly or probably related to the treatment were noted in two prodromal patients (tremor/tic, exhaustion/anxiety) and three first-episode patients (sedation, dystonia, dry mouth/rhinitis); all of these were minor and resolved during the trial. Of the six patients who dropped out, only one (a first-episode patient) withdrew because of adverse events. No adverse reactions were observed in the one prodromal patient whose parents withdrew consent to participate.
t1 gives information on symptom severity and neurocognitive functioning in the prodromal and first-episode groups. On average, prodromal patients’ Child Behavior Checklist scores declined significantly at the 12-week follow-up, compared to baseline scores, in terms of thought disorder, attention symptoms, and overall symptoms but not in terms of social functioning. All four prodromal subjects improved in terms of attention, and three of four improved in terms of thought disorder and overall symptoms. On average, first-episode patients’ Positive and Negative Syndrome Scale scores declined significantly overall and on the positive and negative subscales. All six first-episode patients improved in terms of positive and overall symptoms, and five of six improved in terms of negative symptoms.
Performance on the California Verbal Learning Test improved significantly from baseline to final follow-up in terms of trial 1 recall (mean change=98.2%, SD=92.8%) (t=3.3, df=10, p=0.008), overall recall on trials 1 to 5 (mean=28.7%, SD=27.8%) (t=3.3, df=10, p=0.009), semantic clustering during recall (mean=263.4%, SD=218.8%) (t=3.8, df=10, p=0.004), and recall errors (i.e., sum of intrusions and perseverations: mean=–54.6%, SD=12.2%) (t=–14.1, df=10, p=0.0001). The rate of improvement did not differ significantly between first-episode and prodromal subjects on any of these measures (t=0.6, df=9, p=0.59; t=–1.2, df=9, p=0.27; t=–1.1, df=9, p=0.31; t=–0.1, df=9, p=0.95, respectively). Significant change was observed on trial 1 recall among prodromal patients and on all measures but recall errors among first-episode patients.