NCT00510146已完成3 期
Efficacy and Safety of Olanzapine in the Treatment of Patients With Bipolar I Disorder, Depressed: A Randomized, Double-Blind Comparison With Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 514
- 试验地点
- 1
- 主要终点
- Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)
研究概览
简要总结
The purpose of this study is to assess whether olanzapine is superior to placebo in patients with bipolar depression.
详细描述
-
Dose range and administration mode: Oral Olanzapine 5mg - 20mg/day
-
Duration:
-
Screening phase is 2-28 days.
-
Double-blind treatment phase is 6 weeks
-
Open-label extension phase is 18 weeks
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent
- •All female patients must test negative for pregnancy and females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug
- •Patients must fulfill the criteria for a major depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) as well as criteria for bipolar I disorder, depressed, as defined in the DSM-IV-TR, based on clinical assessment and confirmed by the structured diagnostic interview, the Mini International Neuropsychiatric Interview (MINI), at study entry
- •Patients must have a current 17-item Hamilton Depression Rating Scale (HAMD-17) score greater than or equal to 18 at Visit 1 and Visit 2
- •Patients must have a current Young Mania Rating Scale (YMRS) total score less than or equal to 8 at Visit 2.
排除标准
- •Has received treatment within the past 30 days with a drug (not including study drug) that has not received regulatory approval for any indication at the time of study entry
- •Has participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) before study entry
- •Was previously treated with olanzapine and had bipolar depression considered to be treatment-resistant to olanzapine or to olanzapine in combination with an available selective serotonin reuptake inhibitor (SSRI)
- •Is experiencing (at the time of study entry) a current episode of bipolar depression that is greater than 90 days in duration
- •Has been treatment-resistant to any therapy prescribed for bipolar depression when olanzapine alone or with an SSRI prescribed at an appropriate dose and duration
研究组 & 干预措施
Olanzapine
Experimental
During double-blind treatment, participants receive olanzapine at a dose of 5 milligram (mg) which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
干预措施: Olanzapine (Drug)
Placebo
Placebo Comparator
Matching placebo administered once daily, by mouth during double-blind treatment.
干预措施: Placebo (Drug)
Olanzapine (open-label treatment period)
Experimental
During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and Week 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
干预措施: Olanzapine (Drug)
结局指标
主要结局
Change From Baseline to Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (Acute Phase)
时间窗: Baseline, Endpoint (Week 6)
The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
次要结局
- Percentage of Participants With Symptomatic Response at Endpoint (Acute Phase)(Endpoint (Week 6))
- Percentage of Participants With Symptomatic Remission At Any Time (Acute Phase)(Baseline through Endpoint (Week 6))
- Change From Baseline to Endpoint in Clinical Global Improvement- Bipolar (CGI-BP) Severity of Illness Scores-Mania, Depression, Overall Bipolar Illness Scores (Acute Phase)(Baseline, Endpoint (Week 6))
- Percentage of Participants With Recovery (Acute Phase)(Baseline through Endpoint (Week 6 ))
- Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Hamilton Depression Rating Scale-17 (HAMD-17) Total Score (Acute Phase)(Baseline, Endpoint (Week 6))
- Percentage of Participants With Major Depressive Episode at Endpoint on Mini International Neuropsychiatric Interview (MINI), Depressive Episode Module (Acute Phase)(Endpoint (Week 6))
- Percentage of Participants With Current Hypomanic Episode at Endpoint on MINI Manic Episode Module (Acute Phase)(Endpoint (Week 6))
- Percentage of Participants With Psychotic Disorders and Mood Disorders With Psychotic Features at Endpoint on MINI Psychotic Disorders Module (Acute Phase)(Endpoint (Week 6))
- Percentage of Participants With Alcohol Dependence and Abuse at Endpoint on MINI Alcohol Dependence/Abuse Module (Acute Phase)(Endpoint (Week 6))
- Percentage of Participants With Non-Alcohol Psychoactive Substance Use Disorder at Endpoint on MINI Substance Dependence/Abuse Module (Acute Phase)(Endpoint (Week 6))
- Percentage of Participants With Emergence of Mania During the Study (Acute Phase)(Baseline through Endpoint (Week 6))
- Percentage of Participants With Extra-Pyramidal Symptoms (EPS) At Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Acute Phase)(Endpoint (Week 6))
- Change From Baseline to Endpoint in Blood Pressure (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Weight (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Albumin (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Alanine Amino Transferase/Serum Glutamate Pyruvate Transaminase (ALT/SGPT), Aspartate Aminotransferase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT), Gamma Glutamyl Transferase (GGT)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Direct Bilirubin, Total Bilirubin, Uric Acid (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Erythrocyte Count (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Hematocrit (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Hemoglobin A1c (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Hemoglobin (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Prolactin (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Urinalysis (UA)- Specific Gravity (Acute Phase)(Baseline, Endpoint (Week 6))
- Change in Electrocardiogram (ECG) From Baseline to Endpoint (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in Heart Rate (Acute Phase)(Baseline, Endpoint (Week 6))
- Change From Baseline to Endpoint in MINI Suicidality Total Scores (Acute Phase)(Baseline, Endpoint (Week 6))
- Number of Participants With Adverse Events (Acute Phase)(Baseline through Week 6 (Acute Phase))
- Percentage of Participants With Symptomatic Response in Montgomery-Asberg Depression Rating (MADRS) Depression Rating (Open-Label Phase)(Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24))
- Percentage of Participants With Symptomatic Remission in the MADRS Total Score (Open-Label Phase)(Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24))
- Percentage of Participants With Recovery (Open-Label Phase)(Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24))
- Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Score (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Percentage of Participants With Emergence of Mania During the Study (Open-Label Phase)(Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24))
- Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Endpoint As Measured by Drug-Induced Extra-Pyramidal Symptoms Scale (DIEPSS) (Open-Label Phase)(Endpoint (Week 24))
- Change From Baseline to Endpoint in Blood Pressure (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Weight (Open-Label Phase)(Baseline (End of Acute Phase/ Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Albumin and Total Protein (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Alkaline Phosphatase, Creatinine Phosphokinase (CPK), GGT (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Chloride (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Creatinine (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Erythrocyte Count (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Hemoglobin (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Platelet Count (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Prolactin (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Uric Acid (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Glucose and Lipids (Cholesterol, Triglycerides, HDL Cholesterol, LDL Cholesterol) (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in ECG (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Change From Baseline to Endpoint in Heart Rate (Open-Label Phase)(Baseline (End of Acute Phase/Week 6), Endpoint (Week 24))
- Percentage of Participants With High Suicidality at Endpoint (Open-Label Phase)(Endpoint (Week 24))
- Number of Participants With Adverse Events (Open-Label Phase)(Baseline (End of Acute Phase/Week 6) through Endpoint (Week 24))
研究者
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