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Trial record 44 of 133 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

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

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ClinicalTrials.gov Identifier: NCT03446846
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Minerva Neurosciences

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 will be randomly assigned to 1 of 3 treatment arms, including placebo, 5.0 mg MIN-117, or 2.5 mg MIN-117 in a 2:1:1 ratio.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: MIN-117 2.5 mg Drug: MIN-117 5.0 mg Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 30, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 5.0 mg MIN-117 Drug: MIN-117 5.0 mg
5.0 MIN-117 capsules administered as a single dose once daily

Experimental: 2.5 mg MIN-117 Drug: MIN-117 2.5 mg
2.5 MIN-117 capsules administered as a single dose once daily

Placebo Comparator: Placebo Drug: Placebo
Placebo oral capsules administered as a single dose once daily




Primary Outcome Measures :
  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS) total score [ Time Frame: Change from Baseline to Week 6 ]
    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.


Secondary Outcome Measures :
  1. Change in Hamilton Anxiety Scale (HAM-A) [ Time Frame: Change from Baseline to Week 6 ]
    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 participant is asked to rate the gravity of each item using a 5-level scale, from 0 to 4, with 4 being the most severe, and afterwards the results are collated and tabulated to determine the severity of anxiety.

  2. Change in Clinical Global Impression of Severity Scale (CGI-S) [ Time Frame: Change from Baseline to Week 6 ]
    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.

  3. Change in Clinical Global Impression of Improvement Scale (CGI-I) [ Time Frame: Change from Baseline to 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).

  4. Percentage of Patients who Experienced at Least One Occurrence of a Given Adverse Event [ Time Frame: Screening to Week 6 ]
    Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). All reported adverse events with onset during the 6-week period will be included. A treatment-emergent adverse event that occurs > 14 days after the date of last dose will not be summarized.

  5. Change in Baseline of Clinical Laboratory Results [ Time Frame: Screening to Week 6 ]
    Changes from Baseline results will be presented in pre- versus post-treatment cross tabulations. Listings of patients with laboratory results outside of reference ranges or with any markedly abnormal results will be provided.

  6. Physical Examination [ Time Frame: Screening to Week 6 ]
    Physical abnormalities will be listed.

  7. Percentage of patients with Vital Sign Values Beyond Clinically Important Limits [ Time Frame: Screening to Week 6 ]
    Change in Baseline of vital signs will be analyzed for each patient.

  8. Percentage of Patients with QTc interval > 450 msec [ Time Frame: Screening to Week 6 ]
    Observed values and changes from Baseline values will be collected.

  9. Percentage of Patients with QTc interval > 480 msec [ Time Frame: Screening to Week 6 ]
    Observed values and changes from Baseline values will be collected.

  10. Percentage of Patients with QTc interval >= 500 msec [ Time Frame: Screening to Week 6 ]
    Observed values and changes from Baseline values will be collected.

  11. Percentage of Patients with QTc interval corrected with Fredercia formula (QTcF) interval increases from Baseline of 30 to 59 msec [ Time Frame: Screening to Week 6 ]
    Descriptive statistics and changes from Baseline will be collected.

  12. Percentage of Patients with QTc interval corrected with Fredercia formula (QTcF) interval increases from Baseline of >= 60 msec [ Time Frame: Screening to Week 6 ]
    Descriptive statistics and changes from Baseline will be collected.

  13. Columbia Suicide Severity Rating Scale [ Time Frame: Screening to Week 6 ]
    Emergence of suicidal ideation will be assessed using the Columbia Suicidal Severity Rating Scale (C-SSRS). C-SSRS is a prospective rating scale that tracks both treatment-emergent suicidal ideation and behaviors. C-SSRS been frequently used in clinical studies and is a standard measure for suicidal ideation assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 contraception for the duration of the study (oral or parenteral hormonal contraceptive or intrauterine device or barrier plus spermicide).
  • 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, and amphetamine/methamphetamine at Screening and randomization.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03446846


Contacts
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Contact: Michael Davidson, MD +1-617-992-6252 mdavidson@minervaneurosciences.com
Contact: Andrzej Piotrowski, MD +48 695 801 366 Andrzej.Piotrowski@kcrcro.com

Locations
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United States, Arkansas
Woodland International Research Group Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
Collaborative Neuroscience Network, LLC. Recruiting
Garden Grove, California, United States, 92845
Collaborative Neuroscience Network, LLC. Recruiting
Torrance, California, United States, 90502
Pacific Clinical Research Medical Group Recruiting
Upland, California, United States, 91786
United States, New Jersey
Hassman Research Institute, LLC. Recruiting
Berlin, New Jersey, United States, 08009
United States, New York
Neurobehavioral Research, Inc, Cedarhurst, NY Recruiting
Cedarhurst, New York, United States, 11516
United States, Ohio
NeuroBehavorial Clinical Research Inc Recruiting
Canton, Ohio, United States, 44718
United States, Oregon
Oregon Center for Clinical Investigations Recruiting
Portland, Oregon, United States, 97214
United States, Texas
FutureSearch Trials Recruiting
Dallas, Texas, United States, 75231
Bulgaria
"Mental Health Center Prof. Dr. Ivan Temkov - Burgas" EOOD Department For Treatment of Emergency Psychiatry Conditions Recruiting
Burgas, Bulgaria
UMHAT "Sveti Georgi" EAD - Plovdiv Recruiting
Plovdiv, Bulgaria
Mental Health Center, Ruse Recruiting
Ruse, Bulgaria
MC Sveti Naum Recruiting
Sofia, Bulgaria
DCC Mladost-M OOD Recruiting
Varna, Bulgaria
Psychiatric Office 521, Etage 5, Corpus V DCC Mladost-M OOD Recruiting
Varna, Bulgaria
Finland
Helsingin Psykiatripalvelu Oy at Mehilainen Clinic, Lääkärikeskus Mehiläinen Recruiting
Helsinki, Finland
Oulu Mentalcare Oy Recruiting
Oulu, Finland
Satakunnan Psykiatripalvelu Oy at Mehiläinen Pori Recruiting
Pori, Finland
Mentoria Recruiting
Tampere, Finland
Poland
Zespół Opieki Zdrowotnej w Chełmnie, Poradnia Zdrowia Psychicznego Recruiting
Chełmno, Poland
Medical University of Gdańsk, Department of Psychiatry UCK Recruiting
Gdańsk, Poland
Klinika Psychiatryczna Inventiva Recruiting
Tuszyn, Poland
Sponsors and Collaborators
Minerva Neurosciences

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Responsible Party: Minerva Neurosciences
ClinicalTrials.gov Identifier: NCT03446846     History of Changes
Other Study ID Numbers: MIN-117C03
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms