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An exploratory open-label trial of aripiprazole as an adjuvant to clozapine therapy in chronic schizophrenia


David C. Henderson, Freedom Trail Clinic, 25 Staniford Street, Boston, MA 02114, USA.


Objective:  We conducted this 6-week open-label trial to examine the effects of adjunctive aripiprazole in clozapine-treated subjects on weight, lipid and glucose metabolism, as well as positive and negative symptoms of schizophrenia.

Method:  Ten clozapine-treated subjects received aripiprazole augmentation; eight completed the 6-week trial and two ended at week 4. Eighty percent were male, the mean age was 38.7 ± 8.9 years and the mean clozapine dose was 455 ± 83 mg daily.

Results:  There was a significant decrease in weight (P = 0.003), body mass index (P = 0.004), fasting total serum cholesterol (P = 0.002) and total triglycerides (P = 0.04) comparing baseline to study endpoint. There was no significant change in total Positive and Negative Syndrome Scale scores.

Conclusion:  This combination may be useful for clozapine-associated medical morbidity and must be studied in placebo-controlled double-blind randomized trials to determine efficacy and safety.