CTRI/2022/11/047063招募中3 期
Phase 3, Randomized, 28 Days, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Brilaroxazine (RP5063) in Subjects with an Acute Exacerbation of Schizophrenia, Followed by a 52-Week Open-label Extension - RECOVER
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1) Subject is male or female, aged 18 to 65 years
- •2) Subject reads, understands, and signs an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved current ICF prior to performing any of the Screening procedures
- •3) Diagnosis schizophrenia
排除标准
- •1)Has a history of treatment resistance exhibited by any of the following:
- •a) No or minimal response to at least 2 periods of treatment lasting 28 days or longer, with antipsychotic agents at the maximally tolerated dose.
- •b) Lifetime history of clozapine use
- •c) History of electroconvulsive therapy (ECT) for treatment of schizophrenia within the past 5 years.
- •2) Is treatment-naïve for schizophrenia.
- •3) Primary current diagnosis other than schizophrenia or a comorbid diagnosis that is primarily responsible for the current symptoms and functional impairment.
- •4) Has a current diagnosis of a psychotic disorder other than schizophrenia or a behavioral disturbance thought to be due to substance abuse disorder.
- •5) Meets criteria for moderate-to-severe substance use disorder within past 6 months prior to Screening (excluding those related to caffeine or nicotine).
- •6) Has a history of the following (a) traumatic brain injury causing ongoing cognitive difficulties, Alzheimers disease, or another form of dementia, or any chronic organic disease of the central nervous system (CNS) (b) intellectual disability of a severity that would impact ability to participate in the study.
- •7) Subject has a current primary DSM-5 diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, post-traumatic stress disorder, obsessive-compulsive disorder, manic episode, hypomania, panic disorder, delirium, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- •8) On antipsychotic within the Screening Period (minimum 3 days prior to Baseline and throughout the study).
- •9) Within 28 days prior to Baseline: monoamine oxidase inhibitors, CNS stimulants, potent CYP3A4 or 5 enzyme-inducing drugs including but not limited to rifampin and carbamazepine and strong CYP3A4 or 5 inhibitors like ketoconazole, itraconazole, clarithromycin, etc.
- •10) Antipsychotic depot medication within 5 half-lives prior to Baseline.
- •11) Positive Urine Drug Screen for drugs of abuse, including amphetamines, barbiturates, cocaine, ecstasy, phencyclidine or opiates meeting criteria of moderate-to-severe DSM-5 substance use disorder.
研究者
相似试验
招募中
3 期
Efficacy and safety study of antiviral Umifenovir therapy in non-severe COVID-19 patients.CTRI/2020/09/027535Director CSIR Central Drug Research Institute
进行中（未招募）
1 期
Phase 3 study of Posoleucel cell therapy for the treatment of adenovirus infection in children and adults receiving standard of care following transplantation of hematopoietic cells (cells responsible for the production of mature blood cells in bone marrow).EUCTR2021-003450-22-ESAlloVir, Inc.80
已完成
3 期
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid ArthritisCTRI/2009/091/000596Pfizer Limited500
进行中（未招募）
1 期
Phase 3 study of Posoleucel cell therapy for the treatment of adenovirus infection in children and adults receiving standard of care following transplantation of hematopoietic cells (cells responsible for the production of mature blood cells in bone marrow).AdV infection in pediatric and adult allo HCT recipients receiving standard of careMedDRA version: 21.1Level: PTClassification code 10060931Term: Adenovirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2021-003450-22-SEAlloVir, Inc.80
进行中（未招募）
1 期
Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued OrkambiMedDRA version: 20.0 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disordersCystic FibrosisEUCTR2017-000540-18-FRVertex Pharmaceuticals Incorporated98