Background:About 30%of the schizophrenic patients were classified as treatment-resistant schizophrenia(TRS),with an undesirable prognosis.Clozapine was one of the most common used atypical anti-psychiatric medications,as its outstanding anti-psychiatric effects,it was recommended as the first-line medication for TRS by several guidelines.However,clozapine has a great metabolic effect,increasing the incidence of metabolic diseases,increasing medical expense,lowering down patients’life quality,and even reducing their survival time.It became a focus issue in psychiatric patients that reducing the metabolic adverse effects of obese schizophrenic patients treated by clozapine.Aripiprazole could reduce the metabolic effects theoretically by its specific pharmaceutical mechanism.There were just a few studies on this issue with small samples.Objective:To explore the metabolic effects of aripiprazole on obese schizophrenic patients treated by clozapine.Methods:Obese patients with schizophrenia prescribed by clozapine were recruited in both outpatient and inpatient department in the Affiliated Brain Hospital of Guangzhou Medical University.A sample of 80 participants,signing up content forms,were randomly divided into study group and control group by random number table.Patients in the study group were prescribed aripiprazole(5-15mg/d)adjunctive with clozapine,while those in the control group were treated by clozapine alone during a 24-week process.Body weight,blood glucose,and blood lipid were collected before treatment,8weeks after treatment,and 24 weeks after treatment,in the meanwhile Clinical Global Impressions-severity scale(CGI-SI)and Treatment Emergent Symptoms Scale(TESS)were used to assess the severity of clinical symptoms and adverse effects.Repeated measurement of variance analysis was used to compare the body weight,blood glucose,and blood lipid between the two groups,and Chi-square test was performed to compare the incidence of adverse effects.Results:36 patients were enrolled in the study group,with a clozapine dose of(213.9±63.9)mg/d.38 patients attended in the control group,with a clozapine dose of(229.6±84.0)mg/d.No significant difference of age(t=1.780,P=0.079),gender(χ2=1.327,P=0.249),marriage status(χ~2=0.704,P=0.703),length of disease(t=1.317,P=0.192),and clozapine dose(t=0.909,P=0.367)were found between the two groups(P>0.05).Median CGI-SI score was both 4 before treatment and 24 weeks after treatment,and the first quartile was both 3,the third quartile was both 4.There was no statistical difference in CGI-SI scores before treatment(Z=-0.281,P=0.779)and 24 weeks after treatment(Z=-0.019,P=0.985)between the two groups.Repeated measurement of variance analysis showed that body weight(F=111.673,P<0.001),waist(F=78.018,P<0.001),BMI(F=111.203,P<0.001)and triglyceride(F=22.660,P<0.001)in the study group dropped off significantly than the control group,while the increasement of cholesterol was less than the control group(F=3.779,P=0.044).Adverse effects were mainly drowsiness,fatigue,salivation,constipation,tachycardia and extrapyramidal side effects in both groups.There was no difference of incidence of adverse effects between the two groups(P>0.05).Conclusion:Aripiprazole adjunctive with clozapine prescribed on obese schizophrenic patients could help in losing body weight,controlling waistline,reducing BMI,and lowering down the levels of total cholesterol and triglyceride.It was safe to prescribe aripiprazole adjunctive with clozapine,which did not affect the patient’s symptom nor lead to extra adverse effects. |