A randomized, placebo-controlled, double-blind study to assess the safety and efficacy of intravenous PCN-101 in treatment-resistant depression

Perception Neuroscience, Inc0 个研究点目标入组 93 人2021年5月11日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Perception Neuroscience, Inc
入组人数: 93
状态: 进行中（未招募）
最后更新: 4年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2021年5月11日

结束日期

待定

最后更新

4年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Perception Neuroscience, Inc

入排标准

入选标准

•Subjects are eligible to be included in the study only if all of the following criteria apply:
•1\. Be capable of giving and give signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
•2\. Be male or female 18 to 65 years of age inclusive at the time of signing the Informed Consent Form (ICF).
•3\. Weigh \= 50 kg and \= 100 kg and have a body mass index (BMI) \= 18 and \= 30\.
•4\. Have a diagnosis of recurrent major depressive disorder (MDD) without psychotic features per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM\-V), confirmed by the Mini\-International Neuropsychiatric Interview (MINI).
•5\. Have a Hamilton Depression Rating Scale (HAM\-D) total score \> 18 at screening and baseline (Day \-1\).
•6\. Have an inadequate response to at least 2 antidepressants in the current episode of depression that were each given for \> 6 weeks at an adequate dose as defined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH\-ATRQ).
•7\. Must be on stable oral antidepressant treatment for at least 30 days before screening.
•8\. Due to the potential for adverse fetal effects, a male subject must be medically confirmed sterile for at least 6 months prior to screening or agree to use highly effective contraception during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period. If a male with a heterosexual partner who is a woman of childbearing potential (WOCBP) is included, his female partner also needs to use highly effective birth control measures.
•9\. Due to the potential for adverse fetal effects, a female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

排除标准

•1\. History of, or current signs and symptoms of, diseases or conditions that would make participation not be in the best interest (eg, compromise the well\-being) of the subject or that could prevent, limit, or confound the protocol\-specified assessments.
•2\. Has a history of seizures.
•3\. Has a current or prior DSM\-V diagnosis of a psychotic disorder or MDD with psychotic features, bipolar or related disorders (confirmed by the MINI), obsessive compulsive disorder (current only), intellectual or autism spectrum disorder, borderline personality disorder, antisocial personality disorder, histrionic personality disorder, or narcissistic personality disorder.
•4\. Has any significant disease or disorder (eg, cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) that, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, influence the results of the study, or affect the subject’s ability to participate in the study.
•5\. Has hypertension (systolic blood pressure \[SBP] \> 140 mm Hg or diastolic blood pressure \[DBP]\> 90 mm Hg) or any past history of hypertensive crisis. An abnormal blood pressure value at screening may be repeated once after 5 minutes of relaxation to determine the subject’s eligibility.
•6\. Has an abnormal ECG of clinical relevance at screening or baseline including, but not limited to, the following:
•QTcF interval \> 450 msec.
•Evidence of 2nd and 3rd degree atrioventricular (AV) block, or 1st degree AV block with PR interval \> 200 msec, left bundle branch block (LBBB) or right bundle branch block (RBBB) at screening or baseline; incomplete RBBB will not permitted.
•Has a history of risk factors including hypokalemia, family history of Long QT Syndrome, or prior use of medications that prolong the QT/QTc interval.
•7\. Has known history of human immunodeficiency virus (HIV); has a positive hepatitis B surface antigen, positive hepatitis C virus antibody serology, or a positive medical history for hepatitis B or C. Subjects with a history of hepatitis B vaccination without a history of hepatitis B are allowed to enroll.