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Major Depressive DisorderPhase 2NCT03446846

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

A Phase 2 study testing MIN-117 5.0 mg and MIN-117 2.5 mg in people with Major Depressive Disorder, run by Minerva Neurosciences at 47 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
MIN-117 5.0 mg and MIN-117 2.5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
360 participants
Where
47 sitesin 7 countries
Study dates
30 Mar 2018to 13 Dec 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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:
  • be post-menopausal, or
  • have had a hysterectomy or tubal ligation or be otherwise incapable of pregnancy, or
  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

47 sites in 7 countries.

47 sites in 7 countries

Ukraine15 sites

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

    Dnipro

  • Municipal non-Profit enterprise "Carpathian Regional Mental

    Ivano-Frankivsk

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

    Kharkiv

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

    Kharkiv

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

    Kherson

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

    Kropyvnytskyi

  • Municipal enterprise "Heikiv Psychoneurological Hospital, Dnipropetrovsk Regional Council"

    Kryvyi Rih

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

    Kyiv

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

    Kyiv

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

    Kyiv

  • National Military-Medical Clinical Center Main Military

    Kyiv

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

    Lviv

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

    Odesa

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

    Poltava

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

    Vinnytsia

Other trials in Ukraine

United States10 sites

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331

  • Hassman Research Institute, LLC

    Berlin, New Jersey, 08009

  • Neuro-Behavorial Clinical Research Inc

    Canton, Ohio, 44718

  • Neurobehavioral Research, Inc, Cedarhurst, NY

    Cedarhurst, New York, 11516

  • FutureSearch Trials

    Dallas, Texas, 75231

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • Woodland International Research Group, LLC

    Little Rock, Arkansas, 72211

  • Oregon Center for Clinical Investigations

    Portland, Oregon, 97214

  • Collaborative Neuroscience Network, LLC

    Torrance, California, 90502

  • Pacific Clinical Research Medical Group

    Upland, California, 91786

Other trials in United States

Bulgaria9 sites

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

    Burgas

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

    Pleven

  • UMHAT "Sveti Georgi" EAD - Psychiatry Clinic

    Plovdiv

  • Mental Health Center, Ruse

    Rousse

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

    Sofia

  • "Medical Center Stimul" OOD, Psychiatric office

    Sofia

  • MC Intermedika

    Sofia

  • MC Sveti Naum, Sofia

    Sofia

  • DCC Mladost-M OOD

    Varna

Other trials in Bulgaria

Poland6 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok

  • Ośrodek Badań Klinicznych - Clinsante S.C.

    Bydgoszcz

  • Zespół Opieki Zdrowotnej w Chełmnie, Poradnia Zdrowia Psychicznego

    Chełmno

  • ISPL

    Gdansk

  • NZOZ Syntonia

    Pruszcz Gdański

  • Prywatna Klinika Psychiatryczna Inventiva

    Tuszyn

Other trials in Poland

Finland4 sites

  • Helsingin Psykiatripalvelu Oy at Mehilainen Clinic, Lääkärikeskus Mehiläinen

    Helsinki

  • Oulu Mentalcare Oy

    Oulu

  • Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori

    Pori

  • Mentoria

    Tampere

Other trials in Finland

Georgia2 sites

  • Center for Mental Health and Prevention of Addiction Ltd

    Tbilisi

  • Tbilisi Mental Health Center Ltd

    Tbilisi

Other trials in Georgia

Moldova1 site

  • Department of Psychiatry, Addiction and Medical Psychology

    Chisinau

Other trials in Moldova

About this study

Official title: 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

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.

Being tested
MIN-117 5.0 mg, MIN-117 2.5 mg, Placebo
Keywords
Major Depressive Disorder, MIN-117
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MIN-117 5.0 mgDrug

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

  • MIN-117 2.5 mgDrug

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

  • PlaceboDrug

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

Study groups in NCT03446846
Study groupRoleWhat they receive
5.0 mg MIN-117ExperimentalMIN-117 5.0 mg (consisting of two 2.5 mg capsules) orally daily for 6 weeks
Receives: Drug: MIN-117 5.0 mg
2.5 mg MIN-117ExperimentalMIN-117 2.5 mg (consisting of one 2.5 mg capsule and one placebo capsule) orally daily for 6 weeks
Receives: Drug: MIN-117 2.5 mg
PlaceboPlacebo comparatorPlacebo (consisting of two placebo capsules) orally daily for 6 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 6

Secondary outcomes (3)

  1. Change in Hamilton Anxiety Scale (HAM-A)

    Hamilton Anxiety Scale (HAM-A) measures the severity of a participant's anxiety, based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. The subject is asked to rate the gravity of each item using a 5-level scale - from 0 to 4, where 0 being not present and 4 being severe - and afterwards, the results are collated and tabulated to determine the severity of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-25 mild to moderate severity, 25-30 moderate to severe, and >30 indicates very severe. To implement the HAM-A, the acting clinician proceeds through the 14 items, evaluating each criterion independently in form of the five-point scale described above.

    Measured: Change from Baseline to the end of Week 6

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

    The Clinical Global Impression of Severity (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis: "Considering your total clinical experience with this particular population, how mentally ill is the participant at this time?" which is rated on the following scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. The CGI-S will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function.

    Measured: Change from Baseline to Week 6

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

    The Clinical Global Impression of Improvement Scale (CGI-I) will provide an overall clinician-determined summary measure that takes into account all available information including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-I consists of a 7-point scale that evaluates the change from initiation of treatment similar to the Clinical Global Impression of Severity Scale (CGI-S). This 7-point scale requires the clinician to assess how much the subject's illness has improved or worsened relative to a Baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.

    Measured: Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2018
  2. Study start30 Mar 2018
  3. Primary completion21 Nov 2019
  4. Study completion13 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03446846
Sponsor's protocol ID
MIN-117C03
Status last verified
Dec 2020
First submitted
20 Feb 2018
Last updated
17 Dec 2020
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MIN-117 5.0 mg and MIN-117 2.5 mg in people with Major Depressive Disorder, run by Minerva Neurosciences at 47 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Ukraine, United States, Bulgaria, Poland, Finland and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03446846.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.

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