NCT01305408已完成3 期
A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder
Cephalon130 个研究点 分布在 3 个国家目标入组 399 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 399
- 试验地点
- 130
- 主要终点
- Change From Baseline to Week 8 in the Total Score From 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 whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.
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
- •The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) criteria and is currently experiencing a major depressive episode.
- •Documentation that the patient has had at least 1 previous manic or mixed episode.
- •The patient has had no more than 6 mood episodes in the last year.
- •The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began.
- •The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone (only if taken in combination with lithium, valproic acid, or lamotrigine). The following criteria must also be met:
- •The mood stabilizer(s) must have been taken a minimum 4 weeks before the onset of the major depressive episode and still be taken at the time of the screening visit at dose or blood level considered appropriate for maintenance therapy by the patient's physician.
- •The patient must continue to take the same mood stabilizer(s) during the screening period; no mood stabilizer may be added during the screening period.
- •The mood stabilizer(s) must be taken for a minimum of at least 8 weeks prior to the baseline visit.
- •The dosage of the mood stabilizer(s) must be stable for a minimum of 4 weeks prior to the baseline visit.
- •The mood stabilizer(s) must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation.
- •The patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine.
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 of the screening visit or during the screening period.
- •The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period.
- •The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present.
- •The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
干预措施: Placebo (Drug)
Armodafinil 150 mg/day
Experimental
Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
干预措施: Armodafinil (Drug)
结局指标
主要结局
Change From Baseline to Week 8 in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)
时间窗: Day 0 (baseline), Week 8
The IDS-C30 is a standardized 30-item, clinician-rated scale to assess the severity of a participant's depressive symptoms. Every effort was made to have the same rater evaluate a participant across all visits. Total scores range from 0-84, with a score of 0 indicating no depression and a score of 84 indicating the most severe depression. Negative change from baseline values indicate improvement in the severity of depression.
次要结局
- Percentage of Responders At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score(Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Change From Baseline to Weeks 4, 8 and Endpoint in the Global Assessment for Functioning (GAF) Scale(Day 0 (baseline), Weeks 4, 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Suicidal Behavior Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Change From Baseline to Different Treatment Weeks in the Total Score From the 30-Item Inventory of Depressive Symptomatology-Clinician-Rated (IDS-C30)(Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Change From Baseline to Different Treatment Weeks in the Total Score From the 16-Item Quick Inventory of Depressive Symptomatology-Clinician-Rated (QIDS-C16)(Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Change From Baseline to Different Treatment Weeks in the Clinical Global Impression of Severity (CGI-S) for Depression(Day 0 (baseline), Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Non-Suicidal Self-Injurious Behavior Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Percentage of Participants in Remission At Different Treatment Weeks According to the 30-Item Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Change From Baseline to Endpoint in the Young Mania Rating Scale (YMRS) Total Score(Day 0 (baseline), last postbaseline observation (up to 8 weeks))
- Participants With Treatment-Emergent Adverse Events (TEAE)(Day 1 to Week 9)
- Change From Baseline to Endpoint in the Hamilton Anxiety Scale (HAM-A) Total Score(Day 0 (baseline), last postbaseline observation (up to 8 weeks))
- Change From Baseline to Endpoint in the Insomnia Severity Index (ISI) Total Score(Day 0 (baseline), last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Actual Attempt Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Preparatory Acts or Behavior Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Completed Suicide Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Non-Specific Active Suicidal Thoughts Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Specific Plan and Intent Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Interrupted Attempt Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Behavior - Aborted Attempt Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Wish to Be Dead Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Some Intent to Act Without a Specific Plan Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
- Columbia-Suicide Severity Rating Scale 'Since Last Visit' Version (C-SSRS-SLV) For Weeks 1, 2, 4, 6, 7, 8, and Endpoint For the Suicidal Ideation - Any Methods (Not Plan) Without Intent to Act Question(Weeks 1, 2, 4, 6, 7, and 8, and last postbaseline observation (up to 8 weeks))
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研究点 (130)
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