EUCTR2007-007555-14-HU
进行中（未招募）
不适用
An 8-Week, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study toEvaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/day) as AdjunctiveTherapy in Adults With Major Depression Associated WithBipolar I Disorder
适应症Major Depression Associated With Bipolar I DisorderMedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depression
相关药物Nuvigil
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Major Depression Associated With Bipolar I Disorder
- 发起方
- Cephalon, Inc.
- 入组人数
- 240
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •(a) The patient has a diagnosis of Bipolar I Disorder according to the DSM\-IV\-TR
- •criteria as determined by the SCID and is currently experiencing a major depressive
- •(b) The investigator has established, by medical record documentation or by history
- •from the patient and reliable informants, that the patient has had at least 1 previous
- •manic or mixed episode, which resulted in functional impairment and was treated (or
- •should have been treated) with a mood stabilizer or antipsychotic medication.
- •(c) The patient has had no more than 6 mood episodes in the last year.
- •(d) The patient’s current major depressive episode must have started no less than
- •4 weeks and no more than 12 months prior to the screening visit.
- •(e) NOTE: The following inclusion criterion is no longer effective with the
排除标准
- •(a) NOTE: The following exclusion criterion is replaced by exclusion criterion (cc):
- •(b) The patient has active psychotic symptoms.
- •(c) The patient has a history of an attention\-deficit/hyperactivity disorder, eating
- •disorder, and/or obsessive compulsive disorder (OCD).
- •(d) NOTE: The following exclusion criterion is replaced by exclusion criterion (dd):
- •(e) NOTE: The following exclusion criterion is replaced by exclusion criterion (ee):
- •(f) The patient has a history of stimulant\-induced mania.
- •(g) In the judgment of the investigator, the patient is at risk of imminent self\-harm.
- •(h) The patient has a history of homicidal ideation or significant aggression.
- •(i) The patient has a history of any clinically significant cutaneous drug reaction.
结局指标
主要结局
未指定
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