Pharmacotherapy of Treatment-Resistant Mania
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- A > 50% reduction in Bech-Rafaelsen Mania Scale score (relative to the baseline score at the start of the phase), and, a total Bech-Rafaelsen Mania Scale score < 11
研究概览
简要总结
Verapamil has been found in some but not all studies to have antimanic activity. Therefore, we investigated the use of verapamil, alone or as an adjunctive treatment, in manic patients who did not respond to an initial adequate trial of lithium. Each study phase lasted three weeks. Subjects were treated openly with lithium in Phase 1 (n=45). Those who failed to respond were randomly assigned to double-blind treatment in Phase 2 with either verapamil (n=10) or continued lithium (n=8). Phase 2 responders were continued on the same medication in Phase 3. Phase 2 nonresponders (n=10) were assigned to combined verapamil/lithium in Phase 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study, patients were required to have a lifetime diagnosis of bipolar 1 or schizoaffective disorder, a current manic episode meeting DSM-IV criteria, and ratings >/= 7 on the Raskin Severity of Mania Scale and >/= 15 on the Bech-Rafaelsen Mania Scale.
排除标准
- •Patients were excluded if they had:
- •A pattern of severe rapid-cycling in which the patient consistently failed to meet the duration criteria for discreet episodes of syndromal mania or depression according to DSM-IV
- •Sustained drug or alcohol abuse within the past three years
- •Schizophrenia
- •Organic affective syndrome
- •A presenting episode that was secondary to the effect of any pharmacologic agent
- •The presence of significant medical illness that would preclude or unduly complicate the intended pharmacologic management of the episode
- •In females, refusal to use appropriate contraception; or
- •Pregnancy.
研究组 & 干预措施
1
Continued-Lithium
干预措施: Lithium (Drug)
2.
Verapamil
干预措施: verapamil (Drug)
3.
Verapamil plus Lithium
干预措施: verapamil plus lithium (Drug)
结局指标
主要结局
A > 50% reduction in Bech-Rafaelsen Mania Scale score (relative to the baseline score at the start of the phase), and, a total Bech-Rafaelsen Mania Scale score < 11
时间窗: 3 weeks
Very much improved or much improved (compared to baseline) on the Clinical Global Impressions scale
时间窗: 3 weeks
次要结局
未报告次要终点