Effect of Cariprazine versus Aripiprazole on Cardiometabolic Profile in Patients with Schizophrenia Switched from Olanzapine due to Weight gain: A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Change in weight-It will be measured by difference in reading obtained by weighing machine at 6 weeks and 12 weeks from baseline.
研究概览
简要总结
Olanzapine and other second generation antipsychotics are efficacious in reducing symptoms of Schizophrenia but are associated with increased risk of metabolic dysfunction which result in obesity and predispose Schizophrenia patient to increased risk of cardiovascular adverse effects resulting in premature death. Dopamine Receptor partial agonist is the new class of Antipsychotics (third generation) which have very less metabolic side effects as compared to second generation Antipsychotics apart from having antipsychotic action. Using them in reducing second generation antipsychotics induced( weight gain and deranged metabolic health ) should significantly decrease metabolic health and thereby reducing premature death in Schizophrenia Patient. Literature search on PUBMED and Google scholar showed that there are limited studies conducted on effect of Cariprazine on metabolic profile in psychosis. That also, we could find it as secondary outcome of the study. There is no head on comparison of Cariprazine and Aripiprazole in ameliorating 2nd generation Antipsychotics (Olanzapine) induced weight gain and derangement of metabolic profile in Schizophrenia. Therefore aim of our study to compare the change in body weight and other cardiometabolic parameters from baseline, and after treatment at 6 weeks and at 12 weeks with Aripiprazole and Cariprazine in schizophrenia subjects switched from olanzapine. The proposed study is a prospective, open label randomized, parallel design trial and will be conducted at single tertiary care centre. The final sample size calculated is 98 (49 participants in each study arm) after considering dropout rate of 20% in the target population. Descriptive statistics in the form of mean, median, range, frequency, percentages, and standard deviation will be used. Comparison of means of continuous variables within groups will be done using repeated measures ANOVA test and between groups will be done by unpaired t test/ Mann-Whitney test. Fisher’s exact test/ t test will be used for categorical variables & continuous variables respectively for demographic data. Data will be analysed by blinded statistician using intention-to-treat (ITT) and per protocol analysis. Statistical analyses will be performed using statistical software SPSS 20.0 (IBM, NY USA) considering a significance level of P<0.05. Cariprazinemay have improvement on cardiometabolic profile in Schizophrenia subjects with olanzapine induced weight gain. It may be used as alternative therapy in schizophrenia subjects with olanzapine induced weight gain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient diagnosed with Schizophrenia who had received olanzapine monotherapy at a dose of 5 to 20 mg per day for a minimum 4 weeks before inclusion Either gender Age between 18 to 65 years Significant weight gain greater than or equal to 7 percent during prior olanzapine therapy to be verified by medical record Increase in weight less than 7 percent with less than 20 percent decrease in Positive and Negative Syndrome Scale score during prior olanzapine therapy for minimum of 4 weeks Patients willing to give informed consent for the therapeutic intervention and to participate in the study.
排除标准
- •Patients who previously failed to respond to an adequate course of Aripiprazole (10mg to 30mg per day for greater than equal to 4 weeks) or Cariprazine (1.5 to 6 mg per day for greater than equal to 4 weeks) Other Schizophrenia spectrum disorders Highly agitated, suicidal patients who need immediate treatment Co-morbid axis I psychiatric illness Patients with co-morbid substance abuse except Nicotine use Pregnant and nursing women Patients with known history of diabetes mellitus- HbA1C greater than 6.5 percent, Patients with known history of hypertension-Blood Pressure greater than equal to 130 mm Hg systolic pressure and 85 mm Hg diastolic Pressure Patients with known history of significant neurological impairment Patient with clinical observable mental retardation History of organicity that precludes participation in study.
结局指标
主要结局
Change in weight-It will be measured by difference in reading obtained by weighing machine at 6 weeks and 12 weeks from baseline.
时间窗: Baseline and 12 weeks
次要结局
- To compare the effect of Aripiprazole on change in body weight with that of Cariprazine at 6 weeks of treatment in schizophrenia patients switched from olanzapine(Baseline and 6 weeks)
- To compare the effect of Cariprazine on change in lipid profile, glucose metabolic RBS and HbA1c and anthropometric waist by hip ratio, Body Mass Index parameters with that of Aripiprazole at 6 and 12 weeks of treatment in schizophrenia patients switched from olanzapine(baseline, 6 weeks, 12 weeks)
- To evaluate the efficacy of Cariprazine versus Aripiprazole measured by change in score by PANSS and SOFAS with that of Aripiprazole at 6 and 12 weeks of treatment in schizophrenia patients switched from olanzapine(baseline, 6 weeks, 12 weeks)
- To evaluate safety of Aripiprazole and Cariprazine in patient of schizophrenia switched from olanzapine(baseline, 6 weeks, 12 weeks)
研究者
Adarsh Verma
All India Institute of Medical Sciences, Patna