Major Depressive Disorder MedDRA version: 20.0 Level: LLT Classification code 10025454 Term: Major depressive disorder, recurrent episode System Organ Class: 100000004873
Conditions
Interventions
Product Name: MIN-117
Product Code: MIN-117
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: N/A
CAS Number: 310392-93-9
Current Sponsor code: MIN-117
Other descriptive name: MIN-117
Concentrat
Sponsors
Minerva Neurosciences, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: 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 hepatitis B surface antigen, or hepatitis C antibody or Human Immunodeficiency Virus (HIV) 1 and 2 antibodies at Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 2 fixed doses (5.0 mg or 2.5 mg) of MIN-117 compared with placebo in reducing the symptoms of major depression measured by the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score over 6 weeks of treatment in adult patients with major depressive disorder (MDD).;Secondary Objective: 1. To assess the change from Baseline of 2 fixed doses (5.0 mg or 2.5 mg) of MIN-117 compared with placebo over 6 weeks of treatment on: • The symptoms of anxiety using the Hamilton Anxiety Scale (HAM-A). • The severity of illness and improvement using the Clinical Global Impression of Severity Scale and Clinical Global Impression of Improvement Scale (CGI S and CGI-I). 2. To evaluate the safety of 2 fixed doses (5.0 mg or 2.5 mg) of MIN-117 compared with placebo over 6 weeks of treatment ;Primary end point(s): Mean change in the MADRS total score from Baseline to Week 6.;Timepoint(s) of evaluation of this end point: The mean change from Baseline to Week 6 in MADRS total score | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Change in symptoms of anxiety using the Hamilton Anxiety scale (HAM-A) 2) Changes in the severity of illness and improvement using the Clinical Global Impression of Severity Scale (CGI-S) and Clinical Global Impression of Improvement Scale (CGI-I). ;Timepoint(s) of evaluation of this end point: 1) mean change from Baseline to Week 6 in HAM-A total score 2) mean changes in CGI-S and CGI-I from Baseline to Week 6 | — |
Countries
Bulgaria, Finland, Poland, Ukraine, United States
Contacts
Public ContactDirector of Clinical Operations
PPRS
Outcome results
None listed