EUCTR2017-001169-26-GB进行中（未招募）1 期
An Adaptive, Phase IIb/III, Multi-center, Prospective, Randomized, Double-Blind Placebo-controlled Study of the Safety and Efficacy of NaBen® (sodium benzoate), a D-Amino Acid Oxidase Inhibitor, as an Add-on Treatment for Schizophrenia in Adults - SNR-04
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 348
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects are required to meet all of the following criteria for randomization into the study:
- •1.Male or female subjects who are between 18 and 55 years of age.
- •2.If female and not infertile (defined below), the subject must agree for the duration of the study to use one of the following forms of contraception 1) systemic hormonal treatment 2) an intrauterine device (IUD) which was implanted at least 2 months prior to screening or 3) double-barrier contraception (condom, diaphragm and spermicide are each considered a barrier). Females are considered to be infertile if they are either a) surgically sterile or b) have had spontaneous amenorrhea for at least the last 2 years and at least 2 years after the onset of amenorrhea while not receiving hormone replacement therapy and had a Follicle-Stimulating Hormone (FSH) level greater than 40 mIU/mL and an estradiol level less than 30 pg/mL.
- •3.Subject is capable of providing informed consent and is willing to sign the ICF prior to study Screening and agrees to comply with the study protocol requirements, , or the subject has a Legally Authorized Representative (LAR) who can provide consent to be enrolled into the study.
- •NOTE: If the subject’s capability to provide ongoing consent during the study alters to the degree that the subject is unable to provide ongoing consent for his/her own study participation per the Investigator and the local regulations, consent should be sought from the subject’s Legally Authorized Representative (LAR) to continue in the study. If a LAR is not available the subject will be withdrawn from the study.
- •4.Physician confirmed DSM-V diagnosis of schizophrenia for the past 2 years based on subject’s history and confirmed by psychiatric evaluation and MINI International Neuropsychiatric Interview For Schizophrenia and Psychotic Disorders, version 7.0 (MINI, Version 7.0).
- •5.The subject is outpatient with no hospitalization for worsening of schizophrenia within 3 months of screening. If the subject is hospitalized during the study for worsening of schizophrenia symptoms the subject will be withdrawn from the study.
- •6.The subject’s schizophrenia condition is clinically stable with residual symptoms. Residual symptoms will be defined as a total score of =110 and = 60 of PANSS per Visit 1 evaluations.
- •7.An unchanged antipsychotic medication regimen for at least eight (8) weeks prior to screening into the study and expected to remain unchanged during the study (longer for depot or long-acting antipsychotics: ten (10) months for Aripiprazole and Paliperidone; six (6) months for Olanzapine pamoate monohydrate; and at least 6 times duration of the reported half life or minimum four (4) months for other depot or long-acting antipsychotics).
- •8.In good general physical health and without clinically significant abnormalities in physical exam, neurological exam and laboratory assessments (urine/blood routine, biochemical tests and ECG) which would exclude the subject from the study in the opinion of the Investigator. For ALT and AST, clinically significant is defined as above twice the upper limit of normal.
- •9.Body Mass Index (BMI) between 17 and 35.
- •10.Subject has a negative routine urine illicit drug screening test (including heroin, amphetamines (including MDMA/ecstasy), cocaine, c
排除标准
- •Subjects meeting any of the following criteria will be excluded from randomization into the study:
- •1.Meets the DSM-V criteria at screening for intellectual disability, dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia, or any other comorbid mental disorders that in the opinion of the Investigator may interfere with study conduct and results interpretation.
- •2.Subjects whose illness was resistant to antipsychotics according to prior treatments of two different antipsychotics of adequate dose.
- •3.Subjects who have been previously treated with clozapine or are currently receiving clozapine.
- •4.Initiation or dose change of lithium, antidepressant or other mood stabilizers within 16 weeks prior to screening.
- •5.Initiation or dose change of benzodiazepines or sleep medications, or any other psychotropic medications due to worsening of schizophrenia symptoms or medication side effects within four (4) weeks prior to screening.
- •6.The subject has previously received NaBen®.
- •7.History of epilepsy, major head trauma, or any neurological illness other than Tourette’s syndrome which might impair the subject’s cognition or psychiatric functioning per the investigator’s judgment.
- •8.History of allergic reaction to sodium benzoate.
- •9.Serious medical illnesses such as end-stage renal disease, liver failure or heart failure that, in the opinion of the Investigator, may interfere with the conduct of the study.
- •10.Any significant gastrointestinal disorders that, in the opinion of the investigator, markedly alter the absorption, metabolism or elimination of sodium benzoate.
- •11.Any movement disorder that might affect the ratings on the EPS scales (e.g. Parkinson’s disease) or any movement disorder that is due to antipsychotic medications and is not currently controlled with anti-EPS medications
- •12.Current substance abuse or history of meeting criteria for moderate or severe substance abuse and/or substance dependence (including alcohol, but excluding nicotine and caffeine) in the past six (6) months prior to screening.
- •13.Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening Visit) or are breast feeding.
- •14.History of cancer not in remission for the last three (3) years except for basal cell carcinoma and squamous cell carcinoma
- •15.Participation in a clinical trial within 3 months prior to screening or more than two clinical trials within 12 months.
- •16.Electroconvulsive Therapy (ECT) within six (6) months prior to screening
- •17.The subject started a new non-medication treatment for schizophrenia or other psychiatric condition within the last 3 months prior to screening (e.g. individual psychotherapy, cognitive behavioral therapy or rehabilitative therapy).
- •18.The subject’s anti-EPS medications dose or regimen has changed within 2 weeks prior to screening.
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