An 8-week, Placebo-controlled, Double-blind, Randomized, Fixed-dose Efficacy and Safety Trial of Asenapine in Adolescent Subjects With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 306
- 主要终点
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
研究概览
简要总结
This study is designed to evaluate whether asenapine, which is approved by the United States Food and Drug Administration (US FDA) for acute treatment of schizophrenia in adults, is also effective in adolescents with schizophrenia. Participants who qualify for the study will be randomly assigned to receive a fixed dose of asenapine (either 2.5 mg or 5 mg twice daily [BID]) or placebo for 8 weeks. Throughout the study, observations will be made on each participant at various times to assess the efficacy and safety of the study treatment. The primary objective of the trial is to demonstrate significant superiority of at least one asenapine dose to placebo, as measured by the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at Day 56.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each participant must have schizophrenia, diagnosed and confirmed by board-eligible or board certified psychiatrists with at least two years of specialization in pediatric/adolescent psychiatric medicine.
- •Each participant must be ≥12 years of age and <18 years of age.
- •Each participant must have a minimum PANSS total score of 80 at Screening and Baseline.
- •Each participant must have a score of at least 4 (moderate) on two or more of the five items in the positive subscale of the PANSS (delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/ persecution) at Screening and Baseline.
- •Each participant must have a CGI-S scale score of ≥4 at Screening and Baseline.
- •Each participant must taper off all prohibited psychotropic medications (including antipsychotics, antidepressants, and mood stabilizers) prior to Baseline.
- •Each participant must agree not to begin formal, structured psychotherapy during the trial.
排除标准
- •A participant must not have a diagnosis of schizoaffective disorder; schizophrenia of residual subtype; schizophrenia of catatonic subtype, or schizophrenia with "continuous," "single episode in partial remission," or "single episode in full remission" course specifiers.
- •A participant must not have a primary Axis I diagnosis other than schizophrenia and must not have a comorbid Axis I diagnosis that is primarily responsible for current symptoms and functional impairment.
- •A participant must not have a known or suspected diagnosis of mental retardation or organic brain disorder.
- •A participant must not currently (within the past 6 months) meet the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR^TM) criteria for substance abuse or dependence (excluding nicotine).
- •A participant must not have a diagnosis of psychotic disorder or a behavioral disturbance thought to be substance induced or due to substance abuse.
- •A participant must not be at imminent risk of self-harm or harm to others, in the investigator's opinion based on clinical interview and responses provided on the Columbia Suicide Severity Rating Scale (C-SSRS).
研究组 & 干预措施
Asenapine 2.5 mg BID
Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks.
干预措施: asenapine 2.5 mg (Drug)
Asenapine 5.0 mg BID
Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period.
干预措施: asenapine 2.5 mg (Drug)
Asenapine 5.0 mg BID
Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period.
干预措施: asenapine 5.0 mg (Drug)
Placebo
Participants receive placebo asenapine tablets sublingually BID for 8 weeks.
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
时间窗: Baseline and Day 56
The PANSS is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia. It consists of 3 subscales: positive subscale (7 items), negative subscale (7 items), and general psychopathology subscale (16 items). Positive symptoms refer to an excess or distortion of normal mental status (e.g., delusions). Negative symptoms represent a diminution or loss of normal functions (e.g., emotional withdrawal). For each item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score for each participant was calculated as the sum of the rating assigned to each of the 30 PANSS items, and ranged from 30 to 210 with a higher score indicating greater severity of symptoms. The reported measure is the change from baseline at Day 56; improvement in symptoms is represented by negative values.
次要结局
- Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS General Psychopathology Subscale Score at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS Negative Subscale Score at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS Positive and Negative Subscale Scores Combined at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS Marder Positive Symptoms Factor Score at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS Marder Disorganized Thoughts Factor Score at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS Positive Subscale Score at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS Marder Hostility/Excitement Factor Score at Day 56(Baseline and Day 56)
- Clinical Global Impression of Improvement (CGI-I) Score at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS Marder Negative Symptoms Factor Score at Day 56(Baseline and Day 56)
- Change From Baseline in PANSS Marder Anxiety/Depression Factor Score at Day 56(Baseline and Day 56)
- Total PANSS 30% Responders(Baseline up to Day 56)
- Kaplan-Meier Estimate of Cumulative Percentage of Participants With Total PANSS 30% Response at End of Study(Baseline up to approximately Day 59)
- CGI-I Responders(Baseline up to Day 56)
- Kaplan-Meier Estimate of Cumulative Percentage of Participants With CGI-I Response at End of Study(Baseline up to approximately Day 58)
- Change From Baseline in Children's Global Assessment Scale (CGAS) Score at Day 56(Baseline and Day 56)
- Change From Baseline in PQ-LES-Q Overall Score (i.e., Item 15) at Day 56(Baseline and Day 56)
- Change From Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) Total Score at Day 56(Baseline and Day 56)