Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

AGN-241751 in the Treatment of Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03726658
Recruitment Status : Active, not recruiting
First Posted : October 31, 2018
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of AGN-241751 in participants with Major Depressive Disorder

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: AGN-241751 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Single- and Multiple-Dose Study of AGN-241751 in Adult Participants With Major Depressive Disorder
Actual Study Start Date : November 8, 2018
Estimated Primary Completion Date : May 16, 2019
Estimated Study Completion Date : May 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AGN-241751 3mg
AGN-241751, oral administration, once per day
Drug: AGN-241751
AGN-241751 is supplied in tablet form

Experimental: AGN-241751 10mg
AGN-241751, oral administration, once per day
Drug: AGN-241751
AGN-241751 is supplied in tablet form

Experimental: AGN-241751 25mg
AGN-241751, oral administration, once per day
Drug: AGN-241751
AGN-241751 is supplied in tablet form

Placebo Comparator: Placebo
Placebo, oral administration, once per day
Drug: Placebo
Placebo is supplied in tablet form




Primary Outcome Measures :
  1. To evaluate the efficacy at 1 day post the initial single oral dose of AGN-241751 compared with placebo in participants with Major Depressive Disorder (MDD) [ Time Frame: 1 Day ]
    Efficacy will be measured by improvement in MADRS total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement


Secondary Outcome Measures :
  1. To evaluate the efficacy at Day 8 and Day15 of AGN-241751 administered orally once daily and at Day 22 (7 days after completion of AGN-241751 dosing) compared with placebo in participants with MDD [ Time Frame: Baseline (Day 1) to Day 22 ]
    Efficacy will be measured by improvement in MADRS total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent from the participant has been obtained prior to any study-related procedures
  • Meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) criteria (American Psychiatric Association, 2013). for MDD (based on confirmation from the modified SCID), with a current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1.
  • Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test if a WOCBP (Women of Childbearing Potential).
  • Female participants willing to minimize the risk of becoming pregnancy for the duration of the clinical study and follow-up period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a WOCBP (Women of Childbearing Potential). OR
  • A WOCBP (Women of Childbearing Potential). who agrees to follow the contraceptive guidance in during the treatment period and for at least 4 to 5 weeks after the last dose of study treatment.
  • Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period. A male participant must agree to use contraception during the treatment period and for at least 10 weeks after the last dose of study treatment and refrain from donating sperm during this period.
  • Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.

Exclusion Criteria:

Psychiatric and Treatment-Related Criteria

  • DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1. Comorbid generalized anxiety disorder, social anxiety disorder, or specific phobias are acceptable provided they play a secondary role in the balance of symptoms and are not the primary driver of treatment decisions.
  • Lifetime history of meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition)criteria for:
  • Schizophrenia spectrum or other psychotic disorder
  • Bipolar or related disorder
  • Major neurocognitive disorder
  • Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
  • Dissociative disorder
  • Posttraumatic stress disorder
  • MDD with psychotic features
  • History of meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) criteria for alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before Screening (Visit 1).
  • History (based on participant report and/or medical records, and investigator judgment) of the following:
  • Inadequate response to ECT, a monoamine oxidase inhibitor, ketamine, or adjunctive treatment with an antipsychotic
  • Treatment with clozapine or any depot antipsychotic
  • ECT, vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the 6 months before Screening (Visit 1) whichever is longer)
  • Tardive dyskinesia, serotonin syndrome, or neuroleptic malignant syndrome
  • Having received:
  • Anticonvulsant/mood stabilizer, within 1 year prior to Screening (Visit 1)
  • Antipsychotic in the current episode, with the exception of quetiapine given for insomnia ≤ 50 mg/day provided it can be safely discontinued prior to Visit 2
  • Combination therapy of 2 or more ADTs in the current episode if given for depression at adequate dose and duration
  • ADT augmentation agent in the current episode
  • Lifetime history of nonresponse to ≥ 2 antidepressants after adequate trials (adequate treatment is defined as at least 6 weeks at an adequate dose(s) based on approved package insert recommendations).
  • Positive result at Screening (Visit 1) from the UDS (Urine Drug Screen) test for any prohibited medication. Exception: Participants with a positive UDS (Urine Drug Screen) at Screening for opiates, cannabinoids, or episodic use of benzodiazepines may be allowed in the study provided:
  • The drug was used for a legitimate medical purpose;
  • The drug can be discontinued prior to participation in the study (except for episodic use of benzodiazepines which may be continued); and
  • A repeat UDS is negative for these substances prior to enrollment (except for episodic use of benzodiazepines which may be continued)
  • A suicide attempt within the past year
  • Prior participation in any investigational study of AGN-241751
  • Initiation or termination of psychotherapy for depression within the 3 months preceding Screening (Visit 1), or plans to initiate, terminate, or change such therapy during the course of the study. (Support meetings or counseling [eg, marital counseling] are allowed provided they are no more frequent than weekly and do not have treatment of depression as their objective.)
  • Ongoing treatment with phototherapy, or termination of phototherapy within 1 month of Visit 1.
  • Known allergy or sensitivity to the study medication or its components.
  • Hypothyroidism or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 1 month before Screening (Visit 1)
  • History of seizure disorder, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes to seizure.
  • Known HIV infection
  • Current enrollment in an investigational drug or device study or participation in such a study within 6 months of entry into this study
  • Employee, or immediate relative of an employee, of the sponsor, any of its affiliates or partners, or the study center
  • Inability to speak, read, and understand the English language sufficiently to understand the nature of the study, to provide written informed consent, or to allow the completion of all study assessments.

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): NCT03726658


Locations
Layout table for location information
United States, Arizona
Alea Research
Phoenix, Arizona, United States, 85012
United States, California
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
United States, Georgia
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08809
United States, Washington
Northwest Clinical Research Center
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Naurex, Inc, an affiliate of Allergan plc
Investigators
Layout table for investigator information
Study Director: Raffaele Migliore Allergan

Layout table for additonal information
Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT03726658     History of Changes
Other Study ID Numbers: 3125-104-002
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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