A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder

NCT ID: NCT03446846

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-30
• Study Completion Date: 2019-12-13

Brief Summary

MIN-117C03 is a 6-week, 3-arm, randomized, double-blind, placebo controlled study to investigate the safety and efficacy of MIN-117 in male and female patients with Major Depressive Disorder, aged 18 to 65 years. Approximately 324 patients were to be randomly assigned to 1 of 3 treatment arms, including placebo, 2.5 mg MIN-117, or 5.0 mg MIN-117, in a 2:1:1 ratio.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MIN-117

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

5.0 mg MIN-117

MIN-117 5.0 mg (consisting of two 2.5 mg capsules) orally daily for 6 weeks

Group Type: EXPERIMENTAL

MIN-117 5.0 mg

Intervention Type: DRUG

5.0 mg MIN-117 administered as two MIN-117 2.5 mg capsules as a single dose once daily

2.5 mg MIN-117

MIN-117 2.5 mg (consisting of one 2.5 mg capsule and one placebo capsule) orally daily for 6 weeks

Group Type: EXPERIMENTAL

MIN-117 2.5 mg

Intervention Type: DRUG

2.5 mg MIN-117 administered as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily

Placebo

Placebo (consisting of two placebo capsules) orally daily for 6 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo administered as two Placebo capsules as a single dose once daily

Interventions

MIN-117 5.0 mg

5.0 mg MIN-117 administered as two MIN-117 2.5 mg capsules as a single dose once daily

Intervention Type: DRUG

MIN-117 2.5 mg

2.5 mg MIN-117 administered as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily

Intervention Type: DRUG

Placebo

Placebo administered as two Placebo capsules as a single dose once daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants must be able to read and understand the consent forms, complete study-related procedures, and communicate with the study staff.
• Participants must have provided written consent to participate in the study and understand that they are free to withdraw from the study at any time.
• Participants must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study in order to participate in the optional pharmacogenomic component of this study. Refusal to consent for this component does not exclude a participant from participation in the clinical study.
• Participants must be aged 18 to 65 years, inclusive, at Screening (Visit 1).
• Meet Diagnostic and Statistical Manual of Mental Disorders 5th edition (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 Structured Clinical Interview for DSM-5 (SCID-5). Their major depressive episode must be deemed "valid" using the Massachusetts General Hospital (MGH) State versus trait; Assessability; Face validity; Ecological validity; and Rule of three Ps [pervasive, persistent, and pathological] (SAFER) criteria interview administered by remote, independent raters.
• Participants must be within a body mass index (BMI) of ≥ 18 to < 35 kg/m2 (BMI = weight (kg)/height(m)2] at Screening (Visit 1).
• Participants have a history of at least one previous episode of depression prior to the current episode.
• Participant 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.
• Current major depressive episode of at least 4 weeks in duration.
• At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 40 on the patient rated Inventory of Depressive Symptoms self-report (IDS-SR30).
• At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 18 on Hamilton Anxiety Scale (HAM-A).
• At Screening (Visit 1) and Baseline (Visit 2), participants must have a score ≥ 4 on the investigator-rated Clinical Global Impression of Severity Scale (CGI-S).
• Participants must be outpatients at the time of randomization (Baseline [Day 1]).
• Participants 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).
• If female, the participant must:

1. be post-menopausal, or

2. have had a hysterectomy or tubal ligation or be otherwise incapable of pregnancy, or

3. 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.

• Female participants of childbearing potential must have a negative serum pregnancy test at Screening (Visit 1) and negative serum and urine pregnancy test at Baseline (Visit 2).

Exclusion Criteria

• A DSM-5 diagnosis of current (active): panic disorder, obsessive compulsive disorder (OCD), post-traumatic stress disorder (PTSD), anorexia nervosa, or bulimia nervosa.
• 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.
• At significant clinical risk for suicidal or violent behavior.
• History of treatment within last 6 months with electroconvulsive therapy (ECT), Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS), or Transcranial Magnetic Stimulation (TMS).
• Potential participant who in the opinion of the investigator should not discontinue, or participate in washout of a prohibited concomitant medication.
• Potential participant who demonstrates a greater than 25% decrease in depressive symptoms as reflected by the IDS-SR30 total score from Screening visit to Baseline visit.
• 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.
• Any serious, untreated, or unstable illnesses, such as: liver or renal insufficiency.
• Any significant pulmonary, endocrine, or metabolic disturbances.
• Documented disease of the central nervous system that could interfere with the study assessments (including by 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.
• 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).
• 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.
• History of alcohol or substance use disorders (except nicotine and caffeine) meeting DSM-5 criteria within 1-year prior to Screening visit.
• 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 at Screening due to prescribed benzodiazepines, tricyclic antidepressants, barbiturates or opiates are accepted but must test negative at Baseline.
• Male participants who have pregnant partners.
• 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.
• QT interval corrected with Fridericia's formula (QTcF) at Screening or Baseline greater than 450 msec for males and 470 msec for females.
• Positive hepatitis B surface antigen, or hepatitis C antibody or Human Immunodeficiency Virus (HIV) 1 and 2 antibodies at Screening.
• Employees of the investigator or study center, when the employee has direct involvement in the proposed study or other studies under the direction of that investigator or study center; also family members of the employee or the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minerva Neurosciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Woodland International Research Group, LLC

Little Rock, Arkansas, United States

Collaborative Neuroscience Network, LLC

Garden Grove, California, United States

Collaborative Neuroscience Network, LLC

Torrance, California, United States

Pacific Clinical Research Medical Group

Upland, California, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Hassman Research Institute, LLC

Berlin, New Jersey, United States

Neurobehavioral Research, Inc, Cedarhurst, NY

Cedarhurst, New York, United States

Neuro-Behavorial Clinical Research Inc

Canton, Ohio, United States

Oregon Center for Clinical Investigations

Portland, Oregon, United States

FutureSearch Trials

Dallas, Texas, United States

Mental Health Centre "Prof. Dr. Ivan-Temkov - Burgas" EOOD Complex Lazur

Burgas, , Bulgaria

"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD, First psychiatric clinic

Pleven, , Bulgaria

UMHAT "Sveti Georgi" EAD - Psychiatry Clinic

Plovdiv, , Bulgaria

Mental Health Center, Ruse

Rousse, , Bulgaria

"Diagnostic-Consultative Center St. Vrach and St. St. Kuzma and Damyan" OOD, Psychiatric office

Sofia, , Bulgaria

"Medical Center Stimul" OOD, Psychiatric office

Sofia, , Bulgaria

MC Intermedika

Sofia, , Bulgaria

MC Sveti Naum, Sofia

Sofia, , Bulgaria

DCC Mladost-M OOD

Varna, , Bulgaria

Helsingin Psykiatripalvelu Oy at Mehilainen Clinic, Lääkärikeskus Mehiläinen

Helsinki, , Finland

Oulu Mentalcare Oy

Oulu, , Finland

Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori

Pori, , Finland

Mentoria

Tampere, , Finland

Center for Mental Health and Prevention of Addiction Ltd

Tbilisi, , Georgia

Tbilisi Mental Health Center Ltd

Tbilisi, , Georgia

Department of Psychiatry, Addiction and Medical Psychology

Chisinau, , Moldova

Podlaskie Centrum Psychogeriatrii

Bialystok, , Poland

Ośrodek Badań Klinicznych - Clinsante S.C.

Bydgoszcz, , Poland

Zespół Opieki Zdrowotnej w Chełmnie, Poradnia Zdrowia Psychicznego

Chełmno, , Poland

ISPL

Gdansk, , Poland

NZOZ Syntonia

Pruszcz Gdański, , Poland

Prywatna Klinika Psychiatryczna Inventiva

Tuszyn, , Poland

Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I.Mechnykov", Regional Center of Psychosomatic Disorders based on Psychoneurology

Dnipro, , Ukraine

Municipal non-Profit enterprise "Carpathian Regional Mental

Ivano-Frankivsk, , Ukraine

State Institution "Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine" Department of Neuroses and Borderline States

Kharkiv, , Ukraine

The Training and Research Medical Complex "The Clinic" otharkiv National Medical University

Kharkiv, , Ukraine

Municipal non-profit enterprise "Kherson Regional Psychiatric Care Facility"

Kherson, , Ukraine

Municipal Non-Profit Enterprise "Kirovohrad Regional Psychoneurological Hospital of Kirovohrad Regional Council

Kropyvnytskyi, , Ukraine

Municipal enterprise "Heikiv Psychoneurological Hospital, Dnipropetrovsk Regional Council"

Kryvyi Rih, , Ukraine

Kyiv Clinical Hospital on Railway Transport #1 of the branch "Health Center" of the joint-stock company "Ukrainian Railway"

Kyiv, , Ukraine

Kyiv Regional Medical Incorporation Psychiatry Center of Novel Treatment and Rehabilitation of Psychotic Disorders

Kyiv, , Ukraine

Municipal Institution of Kyiv Regional Council "Regional Psychiatric and Narcological Medical Association"

Kyiv, , Ukraine

National Military-Medical Clinical Center Main Military

Kyiv, , Ukraine

Municipal non-profit enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"

Lviv, , Ukraine

Municipal Non-Profit Enterprise "Odessa Regional Psychiatric Hospital # 2" "of Odessa Regional Council"

Odesa, , Ukraine

Communal enterprise "Poltava Regional Clinical Psychiatric Hospital named O.F. Maltsev Poltava Regional Council"

Poltava, , Ukraine

Municipal non-profit enterprise"Vinnytsya Regional Psychoneurological Hospital named Acad. O.I. Yushchenko of Vinnytsya Regional Council

Vinnytsia, , Ukraine

Countries

United States; Bulgaria; Finland; Georgia; Moldova; Poland; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MIN-117C03

Identifier Type: -

Identifier Source: org_study_id