EUCTR2015-000306-18-PL进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of 2 doses of MIN-117 in Adult Subjects with Major Depressive Disorder
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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. Subjects must be able to read and understand the consent forms, complete studyrelated
- •procedures, and communicate with the study staff.
- •2. Subjects 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. Male or female subjects must be 18 to 65 years of age, inclusive, at Screening (Visit 1).
- •4. Subjects have a body mass index (BMI) of = 18 to = 35 kg/m2 [BMI = weight (kg)/height (m2)] at Screening (Visit 1)
- •5. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5) criteria for diagnosis of moderate or severe depression without psychotic features (ICD-9 codes 296.32 & 296.33; ICD-10 codes F33.1 & F33.2, respectively) at Screening based on clinical assessment and on the MINI, v7.0.
- •6. Subjects have a history of at least one previous episode of depression prior to the current episode.
- •7. Current major depressive episode of at least 8 weeks in duration.
- •8. Subjects must have a score of = 30 on the investigator-rated MADRS at Screening (Visit 1) and Baseline (Visit 2a).
- •9. Subjects must have a score of = 4 on the investigator-rated CGI-S at Screening (Visit 1) and Baseline (Visit 2a).
- •10. Subjects 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, blood chemistry, hematology, urinalysis, and electrocardiogram (ECG)
- •11. Female subjects must be postmenopausal, have had a hysterectomy or tubal ligation or be otherwise incapable of pregnancy, or must agree to consistent use of contraception for the duration of the study (oral or parenteral hormonal contraceptive or intrauterine device or barrier plus spermicide).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A DSM-5 diagnosis of current (active) obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa.
- •2. Significant past or present neurological or neurosurgical disorder that could interfere with the study assessments (including but not limited to stroke, central nervous system [CNS]-related tumors, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, seizure disorder requiring current anticonvulsants, history of brain injury or trauma, or neurosyphilis).
- •3. History or current diagnosis of schizophrenia or any psychotic disorder, bipolar disorder, mental retardation, or cluster B personality disorders, mood disorder with postpartum onset, somatoform disorders, chronic fatigue syndrome, or fibromyalgia.
- •4. Meeting DSM-5 criteria for substance abuse (alcohol or drugs) within 12 months prior to Screening Visit or substance dependence (except nicotine and caffeine) within 6 months prior to the Screening Visit or positive test for drugs of abuse.
- •5. Moderate or high risk of violent behavior or suicide as assessed by any history of suicide attempt, or a score of > 4 on MADRS item 10.
- •6. History of inadequate treatment response on 2 or more occasions of treatment with approved antidepressants (paroxetine included) as defined by failure to improve when treated with a licensed dose for an adequate duration.
- •7. History of treatment with electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), vagus nerve simulation (VNS), or any related neuromodulator therapy within 6 months prior to the Screening Visit, including light therapy.
- •8. Subjects who, in the opinion of the investigator, should not discontinue, or participate in washout of a prohibited concomitant medication.
- •9. Receiving psychological treatments (e.g., cognitive behavior therapy, interpersonal psychotherapy, or psychodynamic psychotherapy) other than psychoeducational
- •within 1 week prior to Baseline Visit randomization) that has not remained constant for at least 3 months, or that may change during this study.
- •10. Significant past or present metabolic, hepatic (including > 3X upper limit of normal [ULN] in liver function test at Screening and Baseline), renal, hematological, pulmonary, cardiovascular, metabolic, gastrointestinal, or urological disorder.
- •11.Any history of drug or other significant allergy or known hypersensitivity to any of the study drugs.
- •12.History of malignant disease within the past 5 years with the exception of minor superficial skin diseases (i.e., basal cell carcinoma and squamous cell carcinoma).
- •13.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.
- •14.Hypothyroidism or hyperthyroidism, unless stabilized by appropriate medication for at least 3 months prior to Screening (a normal thyroid-stimulating hormone [TSH] is required at sScreening).
- •15. Pregnant or breast-feeding female.
- •17. Positive hepatitis B surface antigen (HBsAg), or hepatitis C antibody, or human immunodeficiency virus (HIV) 1 and 2 antibodies at Screening.
- •18.Subjects with a clinically significant electrocardiogram (ECG) abnormality at Screening or Baseline visits that could be a safety issue in the study, including QT interval value corrected for heart rate using the Fridericia’s formula (QTcF) > 430 msec for males and > 450 msec for females
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