A Phase 3, Randomized, Placebo-Controlled, Double-Blinded Trial Evaluating the Safety and Efficacy of Asenapine in Subjects Continuing Lithium or Valproic Acid/Divalproex Sodium for the Treatment of an Acute Manic or Mixed Episode
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 326
- 主要终点
- Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21
研究概览
简要总结
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.
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
- 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
- •Have bipolar I disorder, current episode manic or mixed
- •Treated with lithium or valproic acid
排除标准
- •Have an unstable medical condition
- •Clinically significant laboratory abnormality.
- •Have a primary diagnosis other than bipolar I disorder.
研究组 & 干预措施
Placebo
Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.
干预措施: Placebo (Drug)
Asenapine
Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID). On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability.
干预措施: Asenapine (Drug)
结局指标
主要结局
Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 21
时间窗: Baseline and Day 21
The least squares mean change from baseline in Y-MRS score at day 21 was assessed. The Y-MRS is a clinician-rated instrument used for assessing the symptoms of mania, composed of 11 items. For the 11 items, scores range from 0 (symptoms absent) to, depending on the item, either 4 (7 items) or 8 (4 items). Scores for individual items add to a total score (range: 0-60), with higher scores indicating greater symptom severity. Further, decreases in symptom severity over time would be reflected by negative changes from baseline. For evaluation of this endpoint, a last observation carried forward (LOCF) analysis was used; baseline values are not eligible to be carried forward to missing post-baseline assessments.
次要结局
- Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 21(Baseline and Day 21)
- Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Depression Score at Day 84(Baseline and Day 84)
- Number of Participants Experiencing an Adverse Event (AE)(Up to Day 114)
- Number of Participants Discontinuing Study Treatment Due to an AE(Up to Day 84)
- Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 42(Baseline and Day 42)
- Least Squares Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Score at Day 84(Baseline and Day 84)
- Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Responder Status(Up to Day 84)
- Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 21(Baseline and Day 21)
- Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Mania Score at Day 84(Baseline and Day 84)
- Number of Participants Achieving Young-Mania Rating Scale (Y-MRS) Remitter Status(Up to Day 84)
- Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 21(Baseline and Day 21)
- Least Squares Mean Change From Baseline in Clinical Global Impressions for Use in Bipolar Disorder (CGI-BP) Severity of Overall Bipolar Illness Score at Day 84(Baseline and Day 84)
- Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 84(Baseline and Day 84)
- Least Squares Mean Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Score at Day 21(Baseline and Day 21)
- Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 21(Baseline and Day 21)
- Least Squares Mean Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Score at Day 84(Baseline and Day 84)
- Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 21(Baseline and Day 21)
- Least Squares Mean Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Score at Day 84(Baseline and Day 84)
- Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 21(Baseline and Day 21)
- Mean Change From Baseline (CFB) at Day 84 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery(Baseline and Day 84)
- Least Squares Mean Change From Baseline in InterSePT Scale for Suicidal Thinking - Modified Version (ISST-Modified) Score at Day 84(Baseline and Day 84)
- Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 21(Baseline and Day 21)
- Mean Change From Baseline (CFB) at Day 21 in Neurocognitive Function as Determined by Central Nervous System Vital Signs (CNS-VS) Test Battery(Baseline and Day 21)
- Percentage of Participants Determined to be Ready to Discharge at Day 84 (Kaplan-Meier Estimation)(Day 84)
- Least Squares Mean Change From Baseline at Day 84 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2)(Baseline and Day 21)
- Least Squares Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), General Activities Subscale Score at Day 84(Baseline and Day 84)
- Least Squares Mean Change From Baseline at Day 21 in Quality of Life as Determined by Short Form-36 Version 2 (SF-36v2)(Baseline and Day 21)