NCT00303602已完成4 期
BMI Evaluation: Placebo and Active Comparator Trial of Olanzapine Zydis Pills Used Sublingually (PLATYPUS)
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
- 149
- 试验地点
- 1
- 主要终点
- Time Course of Change From Baseline in Body Mass Index (BMI)
研究概览
简要总结
This study is testing if under the tongue olanzapine for schizophrenia, related psychosis, schizoaffective disorder or bipolar disorder will have less weight gain than olanzapine that is swallowed, in patients who are already gaining weight on olanzapine.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A
Experimental
Sublingual orally disintegrating olanzapine (SODO)
干预措施: Sublingual orally disintegrating olanzapine (SODO) (Drug)
B
Active Comparator
Oral olanzapine
干预措施: Oral olanzapine (Drug)
结局指标
主要结局
Time Course of Change From Baseline in Body Mass Index (BMI)
时间窗: Visit 2 (Baseline) to Visit 7 (16 Weeks)
Body mass index is an estimate of body fat based on body weight divided by height squared. Comparison of changes at various time points throughout the study. Change = Time point value minus baseline (Visit 2) value.
次要结局
- Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI)(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Change From Baseline to 16 Week Endpoint in Body Mass Index (BMI) for the Treatment Completers(Visit 2 (Baseline) and Visit 7 (16 Weeks))
- Mean Change From Baseline to 16 Week Endpoint in Weight(Visit 2 (Baseline) and Visit 7 (16 Weeks))
- Mean Change From Baseline to 16 Week Endpoint in Waist Circumference(Visit 2 (Baseline) and Visit 7 (Week 16))
- Number of Patients Achieving at Least 5% Loss of Body Weight in Any Post-Baseline Period(Visit 2 (Baseline) to Visit 7 (Week 16))
- Number of Participants Discontinuing the Trial by Visit (Week)(Visit 2 (Baseline) to Visit 7 (Week 16))
- Change From Baseline to 16 Week Endpoint in Subjective Appetite Using a Visual Analog Scale(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Change From Baseline to 16 Week Endpoint in Blood Pressure(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Change From Baseline to 16 Week Endpoint in Fasting Lipoproteins (Total Cholesterol, High-Density Lipoprotein Cholesterol [HDL-Cholesterol], Low-Density Lipoprotein Cholesterol [LDL-Cholesterol] [Calculated], and Triglycerides)(Visit 2 (Baseline) and Visit 7 (Week 16))
- Change From Baseline to 16 Week Endpoint in Fasting Plasma Glucose(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Change From Baseline to 16 Week Endpoint in Fasting Serum Insulin(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Change From Baseline to 16 Week Endpoint in Glycosylated Hemoglobin(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Changes From Baseline to 16 Week Endpoint Homeostasis Model Assessments of Insulin Sensitivity HOMA-S (Calculated)(Visit 2 (Baseline) and Visit 7 (Week 16))
- Number of Participants Meeting a Definition for the Presence of Metabolic Syndrome as Defined by Adult Treatment Panel III (ATP III) Criteria at Baseline and 16 Week Endpoint(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Change From Baseline to 16 Week Endpoint in the Clinical Global Impression-Severity (CGI-S) Scale(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Change From Baseline to 16 Week Endpoint in the Subjective Well-Being Under Neuroleptics (SWN) Scale(Visit 2 (Baseline) and Visit 7 (Week 16))
- Mean Change From Baseline to 16 Week Endpoint in the Global Assessment of Functioning (GAF) Scale(Visit 2 (Baseline) and Visit 7 (Week 16))
研究者
研究点 (1)
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