First-in-Patient Study to Assess the Safety and Tolerability and to Explore the Potential Therapeutic Efficacy of a Novel Glutamate Modulator as Monotherapy and as Add-On Therapy in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 主要终点
- Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients
研究概览
简要总结
The purpose of this study is to explore the safety, tolerability, and potential clinical efficacy of JNJ 40411813 in schizophrenic patients.
详细描述
This is a first-in-human study of JNJ-40411813 in schizophrenic patients who are not currently receiving antipsychotic drug treatment (referred to as "(sub) acute" patients) and in patients who are currently taking antipsychotic drug treatment (referred to as "stable" patients). The study will consist of 2 parts: Part A and Part B. Part A will be open-label (patients will know the identity of study treatment), and (sub)acute schizophrenic patients will receive monotherapy (treatment with one drug) with JNJ-40411813. Part B will be double-blind (patient and study staff will not know the identity of study treatment) and will randomize (assign by chance) patients with stable but symptomatic schizophrenia to receive treatment with JNJ-40411813 or a placebo (treatment identical in appearance to JNJ-40411813 but does not contain active drug) as add-on therapy to their currently prescribed antipsychotic medication. Parts A (JNJ-40411813 monotherapy) and B (JNJ-40411813 add-on therapy) will run simultaneously. Patients will take JNJ-40411813 and placebo capsules orally (by mouth) twice daily (bid) with a meal. Part A: Patients will take JNJ-40411813 50 mg (1 capsule) bid up to 150 mg (3 capsules) bid for up to 12 weeks. Part B: Patients will take JNJ-40411813 50 mg bid or placebo bid for 4 weeks. After 4 weeks, the dose of JNJ-40411813 may be increased up to 150 mg bid for 6 weeks, and patients assigned to placebo may take JNJ-40411813 50 mg bid to 150 mg bid for up to 10 weeks.
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
- •Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive
- •Medically stable on the basis of physical examination, medical history, vital signs, 12-lead ECG and clinical laboratory tests
- •In- or outpatients who have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) at least 1 year prior to screening.
排除标准
- •A current DSM-IV axis I diagnosis other than schizophrenia
- •Any medical condition that could potentially alter the absorption, metabolism, or excretion of the study medication, such as Crohn's disease, liver disease, or renal disease
- •Relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular disorders), renal, hepatic, endocrine, or immunologic diseases
- •PANSS score <50 or >120
- •Other significant and/or unstable systemic illnesses
研究组 & 干预措施
JNJ-40411813 (Part A)
JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks.
干预措施: JNJ-40411813 (Drug)
JNJ-40411813 (Part B)
JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 10 weeks.
干预措施: JNJ-40411813 (Drug)
JNJ-40411813 (Part B)
JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 10 weeks.
干预措施: Antipsychotic medication (Drug)
Placebo and JNJ-40411813 (Part B)
Placebo capsule (s) orally twice daily with a meal for 4 weeks followed by JNJ-40411813 according to tolerability dose range increased from 50 mg to 150 mg twice daily with a meal to 6 weeks.
干预措施: JNJ-40411813 (Drug)
Placebo and JNJ-40411813 (Part B)
Placebo capsule (s) orally twice daily with a meal for 4 weeks followed by JNJ-40411813 according to tolerability dose range increased from 50 mg to 150 mg twice daily with a meal to 6 weeks.
干预措施: Placebo (Drug)
Placebo and JNJ-40411813 (Part B)
Placebo capsule (s) orally twice daily with a meal for 4 weeks followed by JNJ-40411813 according to tolerability dose range increased from 50 mg to 150 mg twice daily with a meal to 6 weeks.
干预措施: Antipsychotic medication (Drug)
结局指标
主要结局
Udvalg for Klinische Undersogelser (UKU) ratings for side effects reported by patients
时间窗: Up to 12 weeks
The number of patients with abnormal results from clinical laboratory tests performed as a measure of safety and tolerability
时间窗: Up to 12 weeks
The number of patients with abnormal results from electrocardiograms (ECGs) performed as a measure of safety and tolerability
时间窗: Up to 12 weeks
The number of patients with abnormal results from physical examinations (including vital signs measurements) performed as a measure of safety and tolerability
时间窗: Up to 12 weeks
Number of patients with adverse events reported as a measure of safety and tolerability
时间窗: Up to 12 weeks
次要结局
- Subjective Well-being under Neuroleptics Scale (SWN) scores to explore potential therapeutic effect of study drug(Up to 12 weeks)
- Plasma (blood) concentration of JNJ-40411813(Up to 12 weeks)
- Positive and Negative Syndrome Scale (PANSS) scores to explore potential therapeutic effect of study drug(Up to 12 weeks)
- Clinical Global Impression - Schizophrenia (CGI-SCH) ratings to explore potential therapeutic effect of study drug(Up to 12 weeks)