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This is a prospective, randomized, flexible-dose, open-label study in patients experiencing their first episode of psychosis (meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition[DSM-IV] criteria for brief psychotic disorder, schizophreniform disorder, schizophrenia, schizoaffective disorder or psychotic disorder not otherwise specified).
At study intake, all but 3 of the patients were antipsychotic naïve.
Dose ranges were 5-20 mg/day of olanzapine, 3-6 mg/day of risperidone, and 3-9 mg/day of haloperidol. At the discretion of the treating physician, the dose and type of antipsychotic medication could be changed, based on clinical efficacy and the profile of side effects during the follow-up period.
Adherence to antipsychotic drugs was assessed using information obtained from patients and close relatives by staff (including nurses, social workers, and psychiatrists involved in the clinical follow-up). For the present investigation, patients were consensually dichotomized into having good adherence (defined as patients regularly taking at least 90% of prescribed medication) or poor adherence during the observational period.
Relapse was defined among patients who achieved clinical improvement and stability (Clinical Global Impression[CGI] rating ≤4 and a decrease of at least 30% on Brief Psychiatric Rating Scale[BPRS] total score and all BPRS key symptom items, by being rated ≤3 for more than 4 consecutive weeks at some point during the first 6 months following program entry) and was defined as any of the following criteria occurring after clinical improvement:
- A rating of ≥5 on any key BPRS symptom items for at least 1 week
- CGI rating of ≥6 and a change score of CGI of “much worse” or “very much worse” for at least 1 week
- Hospitalization for psychotic psychopathology
- Completed suicide
- The key BPRS symptoms were unusual thought content, hallucinations, suspiciousness, conceptual disorganization, and bizarre behavior
- Patients were considered to have relapsed if the relapse state lasted at least 1 week
Of the 140 patients, 91 (65%) relapsed at least once over the 3-year period. The rates for the first relapse at 1 year and 2 years were 20.7% and 40.7%, respectively.
The median time to relapse was 843 days (95% confidence interval, 667-1019) (range, 48-1164).
The time to relapse between adherent (mean=933 days) and nonadherent (mean=568 days) patients was significantly different.
Reference:
Caseiro O, Perez-Iglesias R, Mata I, et al. Predicting relapse after a first episode of non-affective psychosis: a three-year follow-up study. J Psychiatr Res. 2012; 46(8): 1099-1105.