NCT01202604已完成不适用
Prospective, Observational Study for the Maintenance Treatment of Patients With Bipolar Disorder I and II in Greece.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of administered maintenance treatments in bipolar disorder I and II, defined as the percentage of patients who experience a relapse episode during the first 9 months after a mood event (manic or depressive).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects who experienced the last acute mood episode during the last 2 months and are in euthymic state (YMRS score ≤12 and HAM-D score ≤12) for at least two weeks
- •Diagnosis of bipolar disorder I or II (as per DSM-IV), with or without rapid cycling
- •Subjects who have been treated with at least one atypical antipsychotic for the management of an acute mood event (manic or depressive) as monotherapy or in combination with other medication
- •Provision of informed consent prior to study participation
排除标准
- •Subjects fulfilling criteria for diagnosis of any other psychiatric condition (except from bipolar disorder I or II), as per DSM-IV Axis Ι, concomitant organic mental disorder or mental retardation
- •Subjects who have received treatment with a depot
- •Substance abuse or dependence (with the exception of nicotine dependence), as defined by DSM-IV criteria
- •Inability of subjects to comply with the study protocol.
结局指标
主要结局
The proportion of patients (n, %) who will experience a relapse episode (manic, hypomanic, depressive, mixed)
时间窗: During the first 9 months after the acute mood episode or in case of relapse occurrence.
次要结局
- Description of administered treatments for the management of the acute phase of bipolar disorder [mood stabilizers (n,%), antidepressants (n,%), and antipsychotics (n,%)].(4 months and 9 months after the acute mood episode or in case of relapse occurrence)
- Description of management of relapse episodes in patients previously receiving treatment during the maintenance phase(In all visits - during the whole study period (9 months))
- YMRS total score, HAM-D total score(At baseline and final visit (9 months after the acute mood episode))
研究者
研究点 (1)
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