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A Study to Evaluate the Efficacy and Safety of MIN-117 in Adult Patients With Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy and Safety of 2 Fixed Doses (5.0 mg or 2.5 mg) of MIN-117 in Adult Patients With Major Depressive Disorder

NCT03446846•Minerva Neurosciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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).
+9 more criteria

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.
+9 more criteria

Locations (47)

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

Key Dates

Start Date

March 30, 2018

Primary Completion Date

November 21, 2019

Completion Date

December 13, 2019

Last Updated

December 17, 2020

Enrollment

360

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

MIN-117 5.0 mg

DRUG

MIN-117 2.5 mg

DRUG

Placebo

DRUG

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

NCT07115329

Major Depressive Disorder

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RECRUITINGPHASE3

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Major Depressive Disorder (MDD)Depression in Adults+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment

University of Iowa Interventional Psychiatry Service Patient Registry

Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D)