RESUMEN
UNLABELLED: This study sought to examine the effectiveness of sibutramine, a weight loss agent, on clozapine-associated weight gain. METHOD: This was a 12-week double-blind, placebo controlled, randomized trial of sibutramine for weight loss in obese clozapine-treated schizophrenia or schizoaffective disorder subjects. RESULTS: Ten patients were enrolled into the placebo group and 11 patients into the sibutramine group. There were no significant baseline differences between the two groups on age, gender, education, ethnicity, diagnosis, weight, body mass index (BMI), and blood pressure. At week 12, there were no significant differences in changes in weight, BMI, abdominal and waist circumferences, Hba1c, fasting glucose, or cholesterol levels. CONCLUSION: Sibutramine treatment did not show significant weight loss compared with placebo in clozapine-treated patients with schizophrenia or schizoaffective disorder. Further research with a larger sample size and longer follow-up duration is warranted.
Asunto(s)
Antipsicóticos/efectos adversos , Depresores del Apetito/farmacología , Depresores del Apetito/uso terapéutico , Clozapina/efectos adversos , Ciclobutanos/farmacología , Ciclobutanos/uso terapéutico , Obesidad/inducido químicamente , Obesidad/tratamiento farmacológico , Esquizofrenia/tratamiento farmacológico , Aumento de Peso/efectos de los fármacos , Adulto , Antropometría , Antipsicóticos/uso terapéutico , Glucemia/metabolismo , Índice de Masa Corporal , Peso Corporal/efectos de los fármacos , Colesterol/sangre , Clozapina/uso terapéutico , Método Doble Ciego , Ayuno , Femenino , Hemoglobina Glucada , Hemoglobinas/metabolismo , Humanos , Masculino , Obesidad/metabolismo , Trastornos Psicóticos/tratamiento farmacológicoRESUMEN
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.