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

NCT03446846 | Completed Phase 2 Results FDA Drug

• 1 other identifier: MIN-117C03
• Study Type: interventional
• Target: 360
• Locations: 7 countries
• Sites: 47

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

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  The Montgomery-Asberg Depression Rating Scale (MADRS) is a validated, physician-rated scale designed to measure depression severity and detect changes due to antidepressant treatment. The test consists of 10 items, each scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher scores represent a more severe conditions. MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. The test exhibits high inter-rater reliability and its capacity to differentiate between responders and nonresponders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression.

  Week 6

Secondary Outcomes (3)

• Change in Hamilton Anxiety Scale (HAM-A)

  Change from Baseline to the end of Week 6

• Change in Clinical Global Impression of Severity Scale (CGI-S)

  Change from Baseline to Week 6

• Change in Clinical Global Impression of Improvement Scale (CGI-I) at Week 6

  Week 6

Study Arms (3)

5.0 mg MIN-117

EXPERIMENTAL

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

Drug: MIN-117 5.0 mg

2.5 mg MIN-117

EXPERIMENTAL

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

Drug: MIN-117 2.5 mg

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

MIN-117 5.0 mg DRUG

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

5.0 mg MIN-117

MIN-117 2.5 mg 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

2.5 mg MIN-117

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minerva Neurosciences: lead

Study Sites (47)

Woodland International Research Group, LLC

Little Rock, Arkansas, 72211, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Collaborative Neuroscience Network, LLC

Torrance, California, 90502, United States

Location

Pacific Clinical Research Medical Group

Upland, California, 91786, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Hassman Research Institute, LLC

Berlin, New Jersey, 08009, United States

Location

Neurobehavioral Research, Inc, Cedarhurst, NY

Cedarhurst, New York, 11516, United States

Location

Neuro-Behavorial Clinical Research Inc

Canton, Ohio, 44718, United States

Location

Oregon Center for Clinical Investigations

Portland, Oregon, 97214, United States

Location

FutureSearch Trials

Dallas, Texas, 75231, United States

Location

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

Burgas, Bulgaria

Location

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

Pleven, Bulgaria

Location

UMHAT "Sveti Georgi" EAD - Psychiatry Clinic

Plovdiv, Bulgaria

Location

Mental Health Center, Ruse

Rousse, Bulgaria

Location

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

Sofia, Bulgaria

Location

"Medical Center Stimul" OOD, Psychiatric office

Sofia, Bulgaria

Location

MC Intermedika

Sofia, Bulgaria

Location

MC Sveti Naum, Sofia

Sofia, Bulgaria

Location

DCC Mladost-M OOD

Varna, Bulgaria

Location

Helsingin Psykiatripalvelu Oy at Mehilainen Clinic, Lääkärikeskus Mehiläinen

Helsinki, Finland

Location

Oulu Mentalcare Oy

Oulu, Finland

Location

Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori

Pori, Finland

Location

Mentoria

Tampere, Finland

Location

Center for Mental Health and Prevention of Addiction Ltd

Tbilisi, Georgia

Location

Tbilisi Mental Health Center Ltd

Tbilisi, Georgia

Location

Department of Psychiatry, Addiction and Medical Psychology

Chisinau, Moldova

Location

Podlaskie Centrum Psychogeriatrii

Bialystok, Poland

Location

Ośrodek Badań Klinicznych - Clinsante S.C.

Bydgoszcz, Poland

Location

Zespół Opieki Zdrowotnej w Chełmnie, Poradnia Zdrowia Psychicznego

Chełmno, Poland

Location

ISPL

Gdansk, Poland

Location

NZOZ Syntonia

Pruszcz Gdański, Poland

Location

Prywatna Klinika Psychiatryczna Inventiva

Tuszyn, Poland

Location

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

Dnipro, Ukraine

Location

Municipal non-Profit enterprise "Carpathian Regional Mental

Ivano-Frankivsk, Ukraine

Location

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

Kharkiv, Ukraine

Location

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

Kharkiv, Ukraine

Location

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

Kherson, Ukraine

Location

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

Kropyvnytskyi, Ukraine

Location

Municipal enterprise "Heikiv Psychoneurological Hospital, Dnipropetrovsk Regional Council"

Kryvyi Rih, Ukraine

Location

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

Kyiv, Ukraine

Location

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

Kyiv, Ukraine

Location

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

Kyiv, Ukraine

Location

National Military-Medical Clinical Center Main Military

Kyiv, Ukraine

Location

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

Lviv, Ukraine

Location

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

Odesa, Ukraine

Location

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

Poltava, Ukraine

Location

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

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Limitations and Caveats

No notable study limitations were identified.

Results Point of Contact

• Title: Head of Research & Development
• Organization: Minerva Neurosciences, Inc.

jsaoud@minervaneurosciences.com

617.600.7375

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor also masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: February 27, 2018
• Study Start: March 30, 2018
• Primary Completion: November 21, 2019
• Study Completion: December 13, 2019
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-12

Locations

GE (2); MO (1); PL (6); UA (15); BU (9); FI (4); US (10)