Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Insulin Resistance
研究概览
简要总结
This is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80 mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy expenditure, and body composition. In addition, the study will examine insulin's effects on psychopathology and cognition.
Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. Approximately 70 subjects will be enrolled.
详细描述
The specific aims include:
Primary Aims:
- Examine the efficacy of telmisartan added to regular doses of clozapine or olanzapine in improving insulin resistance.
- Examine the efficacy of telmisartan in reducing fasting triglycerides.
Secondary Aims:
- Examine the effects of telmisartan on negative symptoms, positive symptoms, and cognitive function.
- Examine telmisartan's effects on lipids, body composition, and waist/hip ratio.
- Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein (CRP) and interleukin 6 (IL-6).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
- •Treatment with clozapine or olanzapine for at least 6 months
- •Stable dose of antipsychotic agent for at least one month
- •Well establish compliance with out-patient medications
- •Females subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.
排除标准
- •Inability to provide informed consent
- •Current substance abuse
- •Psychiatrically unstable
- •Significant medical illness including severe cardiovascular, hepatic, renal disease
- •Current insulin treatment of diabetes
- •History of immunosuppression
- •Current or recent radiation or chemotherapy treatment for cancer
- •Chronic use of steroids
- •Pregnancy or breast feeding
- •Use of diuretics, digoxin, warfarin because the possible drug-drug interaction of telmisartan
研究组 & 干预措施
A: Telmisartan
(existing Clozapine or Olanzapine treatment) + (Telmisartan)
干预措施: Olanzapine (Drug)
A: Telmisartan
(existing Clozapine or Olanzapine treatment) + (Telmisartan)
干预措施: Telmisartan (Drug)
A: Telmisartan
(existing Clozapine or Olanzapine treatment) + (Telmisartan)
干预措施: Clozapine (Drug)
B: Placebo
(existing Clozapine or Olanzapine treatment) + (Placebo)
干预措施: Placebo (Drug)
B: Placebo
(existing Clozapine or Olanzapine treatment) + (Placebo)
干预措施: Clozapine (Drug)
B: Placebo
(existing Clozapine or Olanzapine treatment) + (Placebo)
干预措施: Olanzapine (Drug)
结局指标
主要结局
Insulin Resistance
时间窗: 12 weeks
Insulin resistance as estimated by homeostasis model of assessment of insulin resistance (HOMA-IR) at week 12 in both the experimental and placebo arm. Insulin resistance is a condition in which cells fail to respond to the normal action of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance.
Triglycerides
时间窗: 12 weeks
Fasting triglycerides assessed in both experimental and placebo arm at week 12.
次要结局
- Lipid Metabolism - LDL-cholesterol and HDL-cholesterol(12 weeks)
- Psychopathology - PANSS Total, PANSS - Negative Score, PANNS - Positive Score and SANS - Total Scores.(12 weeks)
- Body Composition: Waist to Hip Ratio(12 weeks)
- Body Composition: Percent Total Body Fat(12 weeks)
研究者
Xiaoduo Fan
Principal Investigator
University of Massachusetts, Worcester