NCT00481195已完成2 期
An 8 Week Double Blind, Placebo-Controlled, Parallel Group, Fixed Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Cephalon41 个研究点 分布在 2 个国家目标入组 257 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 257
- 试验地点
- 41
- 主要终点
- The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
研究概览
简要总结
The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.
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
- Double (Participant, Investigator)
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
- •The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
- •The patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid.
排除标准
- •The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence).
- •The patient has any clinically significant uncontrolled medical or surgical condition.
- •The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
- •The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
研究组 & 干预措施
Armodafinil
Active Comparator
干预措施: Armodafinil (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The Mean Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)
时间窗: Baseline and 8 weeks from start of study drug administration (or last observation after baseline)
The IDS C30 is a standardized 30 item, clinician rated scale to assess the severity of a patient's depressive symptoms. The scale uses the 9 symptom domains of the DSM-IV criteria to measure symptom severity. The scores range from a minimum of 0 to a maximum score of 84. The higher the score the more severe the symptoms of depression. The data presented here summarizes the change from baseline to Endpoint (either week 8 or the last observation after baseline) in the total score of the IDS-C30.
次要结局
- The Mean Change From Baseline to Week 1 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)(Baseline and 1 week following the start of study drug administration)
- The Mean Change From Baseline to Week 2 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)(Baseline and 2 weeks following the start of study drug administration)
- The Mean Change From Baseline to Week 3 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)(Baseline and 3 weeks following the start of study drug administration)
- The Mean Change From Baseline to Week 4 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)(Baseline and 4 weeks following the start of study drug administration)
- The Mean Change From Baseline to Week 6 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)(Baseline and 6 weeks following the start of study drug administration)
- The Mean Change From Baseline to Week 8 in the 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30)(Baseline and 8 weeks following the start of study drug administration)
- Number of Patients Achieving Remission at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)(Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline))
- Number of Patients Achieving "Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)(Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline))
- Number of Patients Achieving "Sustained Remission" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)(Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline))
- Number of Patients Achieving "Sustained Response" at Endpoint According to the 30-item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)(Baseline, 4 and 8 weeks following start of study drug administration (or last observation after baseline))
- Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3(Baseline and 8 weeks (or last observation after baseline))
- Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3(Baseline and 4 weeks following the start of study drug administration)
- Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) Combination of Items 1-3(Baseline and 8 weeks following the start of study drug administration)
- Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4(Baseline and 8 weeks (or last observation after baseline))
- Change From Baseline to Week 4 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4(Baseline and 4 weeks following the start of study drug administration)
- Change From Baseline to Week 8 on 30 Item Inventory of Depressive Symptomatology Clinician Rated (IDS C30) - Item 4(Baseline and 8 weeks following the start of study drug administration)
- Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Baseline and Endpoint (8 weeks following the start of study drug administration or last observation after baseline))
- Change From Baseline to Week 4 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Baseline and 4 weeks following the start of study drug administration)
- Change From Baseline to Week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score(Baseline and 8 weeks following the start of study drug administration)
- Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)(Baseline and 8 weeks (or last observation after baseline))
- Change From Baseline to Week 1 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)(Baseline and 1 week following the start of study drug administration)
- Change From Baseline to Week 2 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)(Baseline and 2 weeks following the start of study drug administration)
- Change From Baseline to Week 3 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)(Baseline and 3 weeks following the start of study drug administration)
- Change From Baseline to Week 4 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)(Baseline and 4 weeks following the start of study drug administration)
- Change From Baseline to Week 6 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)(Baseline and 6 weeks following the start of study drug administration)
- Change From Baseline to Week 8 in the Quick Inventory of Depressive Symptomatology - 16 Items (QIDS-SR16)(Baseline and 8 weeks following the start of study drug administration)
- Change From Baseline to Endpoint (Week 8 or Last Observation After Baseline) in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(Baseline and 8 weeks (or last observation after baseline))
- Change From Baseline to Week 4 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(Baseline and 4 weeks following the start of study drug administration)
- Change From Baseline to Week 8 in the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)(Baseline and 8 weeks following the start of study drug administration)
- Change From Baseline to Endpoint (8 Weeks or Last Observation After Baseline) in Hamilton Anxiety Scale (HAM-A) Total Score(baseline and 8 weeks (or last observation after baseline))
- Change From Baseline to 4 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score(Baseline and 4 weeks following the start of study drug administration)
- Change From Baseline to 8 Weeks in the Hamilton Anxiety Scale (HAM A) Total Score(Baseline and 8 weeks following the start of study drug administration)
- The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Endpoint (Week 8 or Last Observation After Baseline)(Baseline and 8 weeks (or last observation after baseline))
- The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 1(Baseline and 1 week following the start of study drug administration)
- The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 2(Baseline and 2 weeks following the start of study drug administration)
- The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 3(Baseline and 3 weeks following the start of study drug administration)
- The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 4(Baseline and 4 weeks following the start of study drug administration)
- The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 6(Baseline and 6 weeks following the start of study drug administration)
- The Number of Responders According to the Clinical Global Impression of Change - Bipolar Version (CGI BP) Measure of Depression at Week 8(Baseline and 8 weeks following the start of study drug administration)
研究者
研究点 (41)
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