NCT00988728撤回2 期
A Multicenter, Randomized, Parallel-Group, Double-blind, Fixed-Dose, 28-Day Trial to Assess the Efficacy and Safety of SCH 900435 Compared With Placebo, Using Olanzapine as an Active Control in Subjects With an Acute Exacerbation of Schizophrenia (GUEST - Glycine Uptake Inhibitor Efficacy and Safety Trial, Phase 2, Protocol No. P06079)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)
研究概览
简要总结
The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control.
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
- •Subjects eligible to participate:
- •present a substantial and recent exacerbation of schizophrenia
- •have responded positively to treatment with an antipsychotic other than clozapine in the past
- •are without adequate treatment for their symptoms, or willing and capable to stop concurrent medication, which appears inadequate to treat their condition, prior to participation
排除标准
- •Schizoaffective disorder;
- •single episode of schizophrenia in partial remission
- •concomitant use of antidepressants, mood-stabilizers (including anticonvulsants) or long-acting sedatives
- •substance abuse or dependence (excluding nicotine and caffeine)
- •uncompensated medical illness (including clinically relevant eye disorder)
研究组 & 干预措施
SCH 900435
Experimental
SCH 900435 (Org 25935): a Glycine Uptake Inhibitor
干预措施: SCH 900435 (Org 25935) (Drug)
SCH 900435
Experimental
SCH 900435 (Org 25935): a Glycine Uptake Inhibitor
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Olanzapine
Active Comparator
干预措施: Placebo (Drug)
Olanzapine
Active Comparator
干预措施: Olanzapine (Drug)
结局指标
主要结局
The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score)
时间窗: 4 weeks (Day 28)
次要结局
- Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine(4 weeks)
研究者
相似试验
已完成
2 期
Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)Arterial Obstructive DiseasesCoronary DiseaseNCT00132912Merck Sharp & Dohme LLC1,030
已完成
3 期
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)InfertilityNCT01144416Organon and Co1,424
已完成
3 期
Safety and Efficacy of SPD476 (Mesalazine) Given Twice Daily (2.4 g/Day) vs SPD476 Given as a Single Dose (4.8 g/Day) in Subjects With Acute Mild to Moderate Ulcerative ColitisColitis, UlcerativeNCT00503243Shire280
已完成
2 期
A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive PatientsCandidiasis, OralHIV InfectionsNCT00002399Schering-Plough500
已完成
2 期
Adjuvant Treatment With a Glycine Uptake Inhibitor in Participants With Negative Symptoms of Schizophrenia (P05695) (MK-8435-001)SchizophreniaNCT00725075Merck Sharp & Dohme LLC215