Major Depressive Disorder MedDRA version: 18.0 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
Concentration unit: mg milligram(s)
Conc
Sponsors
Minerva Neurosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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. 19. Employees o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of MIN-117 0.5 mg and 2.5 mg compared to placebo in reducing the symptoms of a major depressive episode as measured by the change from Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) total score over 6 weeks of treatment.;Secondary Objective: · To evaluate the efficacy of MIN-117 0.5 mg and 2.5 mg compared to placebo in onset of antidepressant response as measured by the change from Baseline in the MADRS total score over 6 weeks of treatment. · To assess the effects of MIN-117 compared to placebo on severity of illness and improvement using the Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Improvement (CGI-I) over 6 weeks of treatment. · To assess the effect of MIN-117 compared to placebo on sexual functioning using the Arizona Sexual Experiences Scale (A-SEX). · To assess the effect of MIN-117 compared to placebo on executive function and working memory using Digit-Symbol Substitution Test (DSST), Towers of London Test, and Digit Span Backwards task. · To evaluate the safety and tolerability of MIN-117 compared to placebo over 6 weeks of treatment.;Primary end point(s): The change from Baseline to Week 6 in MADRS mean total score will be used as the primary endpoint. ;Timepoint(s) of evaluation of this end point: The change in MADRS: from Baseline to Week 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The change in CGI-S and CGI-I 2. Change from Baseline in MADRS total score over 2 weeks of treatment 3. Change from baseline in cognition and sexual function 4. The rate of responders defined as a decrease in MADRS score of = 50%. 5. Time to clinical response (first assessment with a = 50% improvement from Baseline in total MADRS score scale) 6. The rate of early and sustained full responders (= 50% improvement from Baseline in total MADRS score and a CGI-I score = 2 at every time points) and the rate of remission in MADRS (defined as a score < 12) ;Timepoint(s) of evaluation of this end point: 1. from baseline to week 6 2. Change in MADRS total score from baseline to Week 2 3. Changes in cognition and A-SEX from baseline to Week 6 4. at Week 1, 2, 4 and 6 5. from baseline to week 6 6. from baseline to Week 6 Timepoints of evaluation of endpoints numbered in this section as 1-6 are referring to secondary endpoints listed in section E.5.2 respectively. | — |
Countries
Finland, Latvia, Poland
Contacts
Public ContactHARMOHY - helpdesk
KCR S.A.
Outcome results
None listed