A Randomized, Double-blind, Placebo Controlled Study of the Efficacy of Adjunctive Lithium for the Treatment of Psychotic Mania Followed by an Open Label Long-term Safety Period.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Acute phase :Time to partial or full response
研究概览
简要总结
The proposed pilot study is a placebo-controlled, parallel group, randomized clinical trial comparing two treatment strategies in adolescents with mania and prominent psychotic features. One group will receive a second generation antipsychotic (SGA) and placebo and the other will receive a SGA and lithium.
The primary double-blind phase of the study will last 8 weeks, followed by a 24-week extension-phase.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 12-18 years old, inpatients or outpatients
- •meet DSM-IV criteria for Bipolar I disorder - manic or mixed episode
- •psychotic symptoms present
- •Exclusion criteria:
- •current serious homicidal/suicidal ideation
- •prior non-response or intolerance to an adequate trial of lithium
- •prior non-response or intolerance to adequate trials of both aripiprazole and risperidone
- •any unstable medical condition or medical contraindication to treatment with lithium, aripiprazole or risperidone
- •inability or unwillingness to discontinue concomitant medication that interferes with the pharmacokinetics of either lithium, aripiprazole, or risperidone
- •seizure disorder
- •pregnant or, if sexually active, not using birth control, such as oral contraceptives, two barrier methods, long-acting depot preparations or an intra-uterine device
- •Full Scale IQ less than 70
- •meets criteria for a DSM-IV diagnosis of substance-induced mood disorder or mood disorder due to a general medical condition.
排除标准
- 未提供
研究组 & 干预措施
Lithium/Adjunctive SGA
干预措施: Lithium treatment in combination with a SGA (Second Generation Antipsychotic) (Drug)
Placebo/Adjunctive SGA
干预措施: Placebo/Adjunctive SGA treatment (Drug)
结局指标
主要结局
Acute phase :Time to partial or full response
时间窗: 8 weeks
Acute phase: Partial response is defined as at least a 25% -49% reduction in YMRS score and a CGI improvement item score of 2. Full response is defined as a reduction in YMRS score of 50% or more and a CGI improvement item score of 1 "very much improved."
Continuation Phase: time to recurrence of a subsyndromal mood episode
时间窗: 24 weeks
We will measure the amount of time for patients to have a recurrance of a subsyndomal mood episode during the Continuation Phase
次要结局
- Acute phase: adherence to medication regimen.(8 weeks)
- Acute phase: number of suicidal events(8 weeks)
- Acute phase: positive urine toxicology screens (yes/no variable)(8 weeks)