NCT00472641已完成4 期
Adjunctive Ziprasidone in Overweight and Obese Patients With Bipolar Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.
研究概览
简要总结
This research study is designed to determine if replacing your current antipsychotic and/or mood stabilizer with ziprasidone (Geodon) will impact weight. This research is being conducted because Geodon has a documented effect on mood. Additionally, we believe Geodon to be an effective medication for overweight or obese patients with bipolar disorder. There will be approximately 25 patients enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients will meet the following criteria to be eligible to participate in the study:
- •Diagnosis of Bipolar Disorder Type I, Type II, or NOS treated in ongoing therapy with atypical antipsychotic(s) and/or mood stabilizer(s) that have been implicated in causing weight gain (i.e. lithium, valproate, olanzapine, risperidone, quetiapine, aripiprazole).
- •Age 18-65 years old
- •Males; or nonpregnant, nonlactating females who are postmenopausal, surgically sterilized, or using a barrier method of contraception and have a negative pregnancy test
- •Initial body mass index e 30 kg/m2, or e 27 kg/m2 and demonstrating or receiving treatment for metabolic consequences of overweight (fasting total cholesterol e 200mg/dL, fasting triglycerides e 250 mg/dL, or fasting blood glucose e 100 mg/dL).
- •Stable medication regimen of at least one month
- •Not have been hospitalized due to medical or psychiatric reasons during the past year from date of consent.
- •Ability to understand and cooperate with study procedures
- •Have signed a written informed consent prior to entering the study
排除标准
- •Patients may not participate in the study if they have any of the following conditions:
- •One of the following DSM-IV Axis I diagnoses: delirium, dementia, amnestic and other cognitive disorders, schizophrenia, anorexia nervosa or bulimia, or substance abuse or dependence (active within the last month), abuse of illicit drugs (excluding marijuana) within the past month
- •Antisocial personality disorder
- •Medical complications of obesity such as diabetes, hypertension, hyperlipidemia, and cardiovascular disease unless followed by their own general medical practitioner who authorizes their participation in the trial, and continues to follow them medically and make necessary adjustments of concurrent antidiabetic, antihypertensive, antihyperlipidemic agents during the trial;
- •Item 10 (Suicidal Thoughts) on the MADRS greater than or equal to 4
- •Suicide attempt within the past three months
- •Obesity of endocrine origin
- •Seizure disorders
- •Progressive neurologic or systemic disorders; HIV
- •Other serious illnesses such as cardiac, hepatic (including cirrhosis), renal, respiratory, neurologic, or hematologic disease or glaucoma
- •Hypothyroidism or hyperthyroidism unless adequately treated with TSH no more than 10% above or below the limits of the normal range.
- •Administration of any investigational drug within 30 days prior to screening
- •Allergy or hypersensitivity to ziprasidone
- •Administration of clozapine in the prior three months
- •Pregnancy within the past six months
- •Patients will be discontinued from the study should they develop any significant adverse side effects that cannot be managed by dosage adjustment
研究组 & 干预措施
Ziprasidone/Geodon
Experimental
Ziprasidone/Geodon up to 320 mg per day
干预措施: Ziprasidone/Geodon (Drug)
结局指标
主要结局
The Primary Outcome Measure Was Weight Change From Baseline to Endpoint.
时间窗: Baseline, 12 weeks
The primary outcome measure will be the change in weight from baseline to endpoint using a random regression mixed effects model.
次要结局
- Changes From Baseline to Endpoint in Body Mass Index (BMI)(Baseline, 12 weeks)
研究者
Terrence Ketter
Professor
Stanford University
研究点 (1)
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