A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
研究概览
简要总结
To assess the acute and long-term bimodal efficacy of QTP, as an adjunct to ongoing treatment with lithium (Li) or divalproex (DIV) or lamotrigine (LAM) or any combination of the three thereof, in a group of patients with an index episode of a mixed state in BD.
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
- •Male or female;
- •Age 18 years and older
- •Patients on:
- •Li at a stable dose for 4 weeks or longer, and a serum level at screening of 0.5 mEq/l OR
- •DIV dose for 4 weeks or longer, and a serum level at screening of 45 g/ml OR
- •LAM (dosage/day ≥100mg) at a stable dose for 4 weeks or longer OR
- •Any combination 3a, 3b, or 3c
- •Patients meeting DSM-IV TR diagnosis of bipolar disorder, I or II, as assessed using the MINI, (Sheehan et al., 1998) PLUS any ONE of criteria 5 or 6 or 7
- •Patients meeting DSM-IV TR diagnostic criteria for a mixed manic episode with Young Mania Rating Scale (YMRS) score>/=14 and Montgomery Asberg Depression Rating Scale (MADRS) score>/=14
- •Patients meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14 PLUS Montgomery Asberg Depression Rating Scale (MADRS) score>/=14 ;
- •Patients meeting DSM-IV TR diagnostic criteria for a major depressive episode with the simultaneous presence of MADRS score>/=14 PLUS meeting the criteria for a manic/hypomanic episode for at least 2 days with the simultaneous presence of Young Mania Rating Scale (YMRS) score>/=14
排除标准
- •Patients with a current Axis I diagnosis of schizophrenia, schizophreniform disorder, schizotypal disorder, bipolar disorder with psychotic subtype, drug induced mania or AIDS induced mania
- •Women with a positive pregnancy test or who are lactating
- •Women of child-bearing potential who are not practicing a clinically accepted method of contraception
- •Patients with general medical conditions that contraindicate psychoactive medications or uncontrolled medical disorder or central nervous system diseases.
- •Patients whose clinical status requires inpatient or day hospital treatment
- •History of severe side effects associated with therapeutic doses of Li, DIV, LAM
- •Alcohol or drug dependent at time of enrollment
- •Suicidal at time of enrollment.
- •Current or previous exposure to QTP
研究组 & 干预措施
quetiapine SR
quetiapine SR, 200-600mg, po, qd
干预措施: quetiapine SR (Drug)
quetiapine sr Placebo
quetiapine SR placebo, 200-600mg, po qd
干预措施: quetiapine sr placebo (Drug)
结局指标
主要结局
Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
时间窗: Baseline visit to week 24
The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms.
次要结局
未报告次要终点
研究者
Charles L. Bowden
MD
The University of Texas Health Science Center at San Antonio