Objective: This study compares patient characteristics and treatment response between inpatients treated with clozapine in a research setting as compared to those initiated on clozapine during routine inpatient treatment.
Methods: Subjects on clozapine, in clinical trials, were compared with clozapine inpatients receiving routine clinical care.
Results: At baseline, patients in routine clinical practice had more negative symptoms (P < 0.001), activation (P < 0.001) and greater total Brief Psychiatric Rating Scale (BPRS) scores (P = 0.022) than those in the research setting. Routine clinical practice subjects had larger decreases in BPRS total scores (P = 0.042) and positive item scores (P = 0.0005) compared to research subjects. Response to clozapine was observed in 15/85 (18%) research subjects as compared to 60/223 (27%) patients in routine care (P = 0.09).
Conclusions: Patients treated in routine clinical practice have more severe baseline symptoms, but experience significantly greater improvements in psychiatric symptoms.