An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 931
- 试验地点
- 1
- 主要终点
- Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
研究概览
简要总结
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.
Key objectives of the study are to:
- Determine how well intramuscular (IM) olanzapine depot works during long-term treatment,
- Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment,
- Determine the blood levels of IM olanzapine depot in patients during long-term treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have schizophrenia
- •Female patients of childbearing potential must be using a medically accepted means of contraception
- •Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.
排除标准
- •Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry
- •Female patients must not be pregnant or breast-feeding
- •Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder
- •Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
研究组 & 干预措施
Intramuscular Olanzapine Depot
Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
干预措施: Intramuscular olanzapine depot (Drug)
结局指标
主要结局
Number of Participants Having Normal Fasting Baseline Glucose Value With Treatment-Emergent High Fasting Glucose at Any Time Post Baseline
时间窗: Randomization to end of study up to 76 months
Normal to high fasting glucose ≤100 milligrams per deciliter (mg/dL) at baseline to ≥126 mg/dL any time post baseline.
Number of Participants With Adverse Events (AE)
时间窗: Randomization to end of study up to 76 months
The list of serious adverse events (SAE) and other non-serious adverse events (AE) are in Adverse Events Section.
Number of Participants With Potentially Clinically Significant (PCS) Weight Gain at Month 76 Endpoint
时间窗: Randomization to end of study up to 76 months
PCS weight gain is defined as a ≥7% increase in weight from baseline.
Number of Participants With Extrapyramidal Symptoms at Any Time
时间窗: Randomization to end of study up to 76 months
Extrapyramidal symptoms are defined as Simpson-Angus total score (SAS) \>3 at any post-baseline visit; Barnes Akathisia Scale (BAS) global score ≥2 at any post-baseline visit; A score ≥3 for any of Abnormal Involuntary Movement Scale (AIMS) for items 1-7 or a score ≥2 for any two of these items. Score for SAS is 0-4 for each of the 10 questions, with 0=normal and 4=extreme. The possible total score for SAS is 0-40. Possible score for BAS is 0-5, with 0=absent and 5=sever. Score 0-4 for each item of AIMS, with 0 =none and 4= sever. Possible total score for items 1-7 is 0-28.
Number of Participants With Treatment-Emergent Abnormal High Alanine Transaminase (ALT), High Aspartate Transaminase (AST), High Total Bilirubin at Any Time Post Baseline
时间窗: Randomization to end of study up to 76 months
High ALT is defined as a baseline value of \<3 times the upper limit of normal (ULN) to ≥3 times the ULN at any time post baseline. High AST is defined as a baseline value of \<5 times the ULN to ≥5 times the ULN at any time post baseline. High total bilirubin is defined as a baseline value of \<2 times the ULN to ≥2 times the ULN at any time post baseline.
Number of Participants With Treatment-Emergent Abnormal High Prolactin at Any Time Post Baseline
时间窗: Randomization to end of study up to 76 months
Prolactin normal reference ranges for female: 2.0 - 29.0 nanograms per milliliter (ng/mL); male: 2.0 - 20.0 ng/mL. High value is defined as a change from a value less than or equal to the high limit at all baseline visits to a value greater than the high limit at any time after baseline.
Number of Participants Having Normal Fasting Baseline Lipid Value With Treatment-Emergent High Fasting Lipid at Any Time Post Baseline
时间窗: Randomization to end of study up to 76 months
Normal to high fasting total cholesterol ≤200 mg/dL at baseline to ≥240 mg/dL any time post baseline. Fasting triglycerides \<150 mg/dL at baseline to ≥200 mg/dL and \<500 mg/dL any time post baseline.
Change From Baseline in Weight at Month 76 Endpoint
时间窗: Baseline, up to 76 months
Mean change in weight from baseline to last observation carried forward (LOCF) endpoint.
次要结局
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Scores at Month 76 Endpoint(Baseline, up to 76 months)
- Change From Baseline in PANSS Negative Scores at Month 76 Endpoint(Baseline, up to 76 months)
- Change From Baseline in PANSS Positive Scores at Month 76 Endpoint(Baseline, up to 76 months)
- Change From Baseline in PANSS General Psychopathology Subscales at Month 76 Endpoint(Baseline, up to 76 months)
- Change From Baseline in Clinical Global Impression-Severity of Illness (CGI-S) Scores at Month 72 Endpoint(Baseline, up to 72 months)
- Change From Baseline in the Heinrichs-Carpenter Quality of Life Scale (QLS) Total Score at Month 76 Endpoint(Baseline, up to 76 months)
- Change From Baseline in 36-Item Short Form Health Survey (SF-36) at Month 76 Endpoint(Baseline, up to 76 months)
- Number of Psychiatric Visits(Randomization to end of study up to 76 months)
- Days of Hospitalization(Randomization to end of study up to 76 months)
- Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment-Short Form (SWN-S) at Month 76 Endpoint(Baseline, up to 76 months)
- Patient Satisfaction With Medication Questionnaire-Modified (PSMQ) at Month 76 Endpoint(Randomization to end of study up to 76 months)
- Plasma Olanzapine Concentrations in Participants During Long-Term Treatment by Year(Randomization to end of study up to 76 months)