EUCTR2017-005149-64-BG进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (5.0 mg or 2.5 mg) of MIN-117 in Adult Patients with Major Depressive Disorder
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 360
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
- 性别
- All
入选标准
- •1. Patients must be able to read and understand the consent forms, complete study-related procedures, and communicate with the study staff.
- •2. Patients must have provided written consent to participate in the study and understand that they are free to withdraw from the study at any time.
- •3. Patients must be aged 18 to 65 years, inclusive, at Screening (Visit 1).
- •4. Meet DSM-5 criteria for diagnosis of moderate or severe major depression with anxious distress and without psychotic features at Screening based on clinical assessment and on the SCID-5 (DSM-5 codes: 296.32, 296.33; ICD-10 codes: F33.1, F33.2). Their major depressive episode must be deemed valid using the Massachusetts General Hospital (MGH) SAFER criteria interview administered by remote, independent raters.
- •5. Patients must be within a body mass index (BMI) of = 18 to < 35 kg/m2 [BMI = weight (kg)/height (m)2] at Screening (Visit 1).
- •6. Patients have a history of at least one previous episode of depression prior to the current episode.
- •7. Patient must have been treated with an antidepressant administered at an adequate dose and duration in the past for the treatment of Major Depression. An adequate treatment is defined as an antidepressant treatment for at least 4 weeks at at least the minimum therapeutic dose, for any particular antidepressant.
- •8. Current major depressive episode of at least 4 weeks in duration.
- •9. At Screening (Visit 1) and Baseline (Visit 2), patients must have a score = 40 on the patient rated IDS SR30.
- •10. At Screening (Visit 1) and Baseline (Visit 2), patients must have a score = 18 on HAM-A.
- •11. At Screening (Visit 1) and Baseline (Visit 2), patients must have a score = 4 on the investigator-rated CGI-S.
- •12. Patients must be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, vital signs, blood chemistry, hematology, urinalysis, and electrocardiogram (ECG).
- •13. If female, the patient must:
- •be post-menopausal, or
- •have had a hysterectomy or tubal ligation or be otherwise incapable of pregnancy, or
- •must agree to consistent use of 2 methods of contraception for the duration of the study and until 90 days after the last dose of study medication. One of which must be a highly effective method defined as one that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly. The following highly effective contraception methods acceptable for this study are hormonal contraception (oral or parenteral hormonal contraceptive) or placement of an intrauterine device. The following methods can be used as a second form of contraception during the study: Barrier methods for female patients include their partner’s use of a condom or the subject’s use of an occlusive cap (diaphragm or cervical/ vault caps) with spermicidal foam, gel, film, cream or suppository.
- •14. If male with partner of childbearing potential, must be willing to use one barrier method of contraception with his partner throughout the study (a condom or his partner’s use of an occlusive cap [diaphragm or cervical/ vault caps]). His partner must also be using a highly effective method of birth control defined as one that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, and intrauterine devices for up to
排除标准
- •1. A DSM-5 diagnosis of current (active): panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa.
- •2. History or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders, mood disorder with postpartum onset, somatoform disorders, fibromyalgia, or idiopathic medical conditions.
- •3. At significant clinical risk for suicidal or violent behavior.
- •4. Potential patient who demonstrate a greater than 25% decrease in depressive symptoms as reflected by the IDS-SR30 total score from Screening visit to Baseline visit.
- •5. Active cardiovascular disease (including but not limited to: atrial fibrillation or flutter, second and third-degree atrioventricular heart block, resting supraventricular tachycardia >100 beats per minute, unstable ischemic heart disease, valvular abnormality, sick sinus syndrome or other condition requiring pacemaker) or diastolic blood pressure > 105 mmHg.
- •6. Any serious, untreated, or unstable illnesses, such as: liver or renal insufficiency.
- •7. Any significant pulmonary, endocrine, or metabolic disturbances.
- •8. Documented disease of the central nervous system that could interfere with the study assessments (including but not limited to: stroke, tumor, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, seizure disorder requiring current anti-convulsants, traumatic brain injury or trauma, and neurosyphilis.
- •9. Hypothyroidism or hyperthyroidism, unless stabilized by appropriate medication for at least 3 months prior to Screening (a normal thyroid-stimulating hormone [TSH] is required prior to randomization at Baseline).
- •10. Any medical condition that can potentially alter oral enteral absorption (e.g., gastrectomy), metabolism (e.g., liver failure), or excretion (e.g., renal failure) of the study drug.
- •11. History of alcohol or substance use disorders (except nicotine and caffeine) meeting DSM-5 criteria within 1-year prior to Screening visit.
- •12. Positive alcohol and urine drug screen for opiates, cocaine, barbiturates, tetrahydrocannabinol, methadone, and amphetamine/methamphetamine at Screening and randomization.
- •13. QTcF interval at Screening or Baseline greater than 450 msec for males and 470 msec for females.
- •14. Positive alcohol and urine drug screen for opiates, cocaine, barbiturates, tetrahydrocannabinol, methadone, tricyclic antidepressants, benzodiazepines and amphetamine/methamphetamine at Screening or Baseline. Patients with positive testing due to prescribed benzodiazepines, tricyclic antidepressants, barbiturates, or opiates at Screening are accepted but must test negative at Baseline (Visit 2).
- •15. Male patients who have pregnant partners.
- •16. Female patients who are breastfeeding.
- •17. Received an experimental drug or used an experimental medical device within 60 days before the planned start of treatment (Day 1) or have participated in 2 or more clinical trials in the previous 2 years.
- •18. QTcF interval at Screening or Baseline greater than 450 msec for males and 470 msec for females.
- •19. Patients requiring treatment with drugs likely to prolong QT.
- •20. Patients with known hypersensitivity to MIN-117 or placebo or their excipients (refer to Section
- •13.1 of the protocol)
- •21. Positive hepatitis B surface antigen, or hepatitis C antibody or Human Immunodeficiency Virus (HIV) 1 and 2 antibodies at Screening.
- •22. Employees of the investigator or study
研究者
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