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Trial record 42 of 134 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03586427
Recruitment Status : Recruiting
First Posted : July 13, 2018
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
To evaluate the efficacy at 1 day post initial oral dose of AGN-241751 compared with placebo in participants with MDD

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: AGN-241751 Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Fixed-Dose Study of AGN-241751 in Adult Participants With Major Depressive Disorder
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : June 21, 2019
Estimated Study Completion Date : July 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AGN-241751 Dose 1
AGN-241751 Dose 1 administered as 1 tablet taken orally every day
Drug: AGN-241751
AGN-241751 administered orally as a single tablet

Experimental: AGN-241751 Dose 2
AGN-241751 Dose 2 administered as 1 tablet taken orally every day
Drug: AGN-241751
AGN-241751 administered orally as a single tablet

Experimental: AGN-241751 Dose 3
AGN-241751 Dose 3 administered as 1 tablet taken orally every day
Drug: AGN-241751
AGN-241751 administered orally as a single tablet

Experimental: AGN-241751 Dose 4
AGN-241751 Dose 4 administered as 1 tablet taken orally every day
Drug: AGN-241751
AGN-241751 administered orally as a single tablet

Placebo Comparator: Placebo
Placebo administered as 1 tablet taken orally every day
Other: Placebo
Placebo administered orally as a single tablet




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



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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:

  1. Written informed consent from the participant has been obtained prior to any study -related procedures (as described in Appendix 3).
  2. Male or female participants must be 18 to 65 years of age, inclusive, at the time of signing the informed consent.
  3. Meet Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for MDD (based on confirmation from the modified Structured Clinical Interview for DSM disorders [SCID]), with a current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1.
  4. Have a minimum score of 26 on the rater-administered MADRS and a minimum score of 24 on the computer-administered MADRS at both Visit 1 (Screening) and Visit 2 (Baseline).
  5. Have a difference of no greater than 7 points between the rater-administered MADRS and computer-administered MADRS at both Visit 1 (Screening) and Visit 2 (Baseline).
  6. Have a CGI-S score ≥ 4 at both Visit 1 (Screening) and Visit 2 (Baseline).
  7. Have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test if a woman of childbearing potential (WOCBP).
  8. 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:

    1. Not a WOCBP OR
    2. A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 5 terminal half-lives after the last dose of study treatment.
  9. 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 as detailed in Appendix 5 of this protocol during the treatment period and for at least 5 terminal half-lives after the last dose of study treatment and refrain from donating sperm during this period.
  10. Able, as assessed by the investigator, and willing to follow study instructions and likely to complete all required study visits.
  11. Normal physical-examination findings, clinical-laboratory test results, and ECG results from Visit 1 (Screening) or abnormal results that are determined to be not clinically significant by the investigator.
  12. Body mass index (BMI) within the range 18 and 40 kg/m2 (inclusive).
  13. Eligibility confirmed through a formal adjudication process (see Section 9 Diagnostic Assessments).

Exclusion Criteria:

Psychiatric and Treatment-Related Criteria

  1. DSM-5-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.
  2. Lifetime history of meeting DSM-5 criteria for:

    1. Schizophrenia spectrum or other psychotic disorder
    2. Bipolar or related disorder
    3. Major neurocognitive disorder
    4. 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
    5. Dissociative disorder
    6. Posttraumatic stress disorder
    7. MDD with psychotic features
  3. History of meeting DSM-5 criteria for alcohol or substance use disorder (other than nicotine or caffeine) within the 6 months before Visit 1.
  4. DSM-5-based diagnosis of any personality disorder of sufficient severity to interfere with participation in this study in the opinion of the investigator.
  5. History (based on participant report and/or medical records, and investigator judgment) of:

    1. Inadequate response to ECT, a monoamine oxidase inhibitor, ketamine, or adjunctive treatment with an antipsychotic
    2. Treatment with clozapine or any depot antipsychotic
    3. ECT, vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the 6 months before Visit 1 (whichever is longer)
    4. Tardive dyskinesia, serotonin syndrome, or neuroleptic malignant syndrome
  6. Having received:

    1. Anticonvulsant/mood stabilizer, within 1 year prior to Visit 1
    2. 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
    3. Combination therapy of 2 or more ADTs in the current episode if given for depression at adequate dose and duration
    4. ADT augmentation agent in the current episode
  7. 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) or a non-response to an antidepressant after adequate treatment for the current major depressive episode.
  8. Positive result at Visit 1 from the urine drug screen (UDS) test for any prohibited medication. Exception: participants with a positive UDS at Visit 1 for opiates, cannabinoids, or episodic use of benzodiazepines may be allowed in the study provided:

    1. The drug was used for a legitimate medical purpose;
    2. The drug can be discontinued prior to participation in the study (except for episodic use of benzodiazepines which may be continued); and
    3. A repeat UDS is negative for these substances prior to enrollment (except for episodic use of benzodiazepines which may be continued)
  9. Suicide risk, as determined by meeting any of the following criteria:

    1. A suicide attempt within the past year
    2. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the C-SSRS at Visit 1 (Screening) or Visit 2 (Baseline)
    3. MADRS Item 10 score ≥ 5 at Visit 1 (Screening) or Visit 2 (Baseline) on the MADRS
  10. At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator.
  11. Requiring concomitant treatment with any of the prohibited medications, supplements, or herbal products listed in Appendix 6, including any psychotropic drug or any drug with psychotropic activity, except as described in Section 7.7.2.
  12. Prior participation in any investigational study of AGN-241751.
  13. Initiation or termination of psychotherapy for depression within the 3 months preceding 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).
  14. Ongoing treatment with phototherapy, or termination of phototherapy within 1 month of Visit 1.
  15. Known allergy or sensitivity to the study medication or its components. Other Medical Criteria
  16. BMI < 18 kg/m2 or > 40 kg/m2 at screening.
  17. Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
  18. WOCBP and male partners of WOCBP, not using a reliable means of contraception (Appendix 5).
  19. Participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study.
  20. Any cardiovascular disease that is clinically significant, unstable, or decompensated.
  21. Heart rate (supine) of ≤ 45 bpm or ≥ 120 bpm, or any heart rate that is clinically symptomatic at Visit 1 or Visit 2 based upon vital signs.
  22. Any systolic and/or diastolic blood pressure (BP) that is symptomatic or clinically significant in the opinion of the investigator.
  23. History of congenital QTc prolongation or QTc prolongation (screening ECG with QTcF

    ≥ 450 msec for men and QTcF ≥ 470 msec for women).

  24. Hypothyroidism or hyperthyroidism, unless stabilized on appropriate pharmacotherapy with no change in dosage for at least 1 month before Visit 1.
  25. History of seizure disorder, stroke, significant head injury, tumor of the central nervous system, or any other condition that predisposes to seizure.
  26. Known human immunodeficiency virus (HIV) infection.
  27. Positive hepatitis C antibody on screening, with the exception of participants for whom the reflex HCV RNA test is negative.
  28. Positive test for hepatitis B surface antigen and/or hepatitis B core antibody immunoglobulin M.
  29. Screening liver enzyme test (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT]) results > 2 times the upper limit of normal (ULN).

    Other Criteria

  30. Current enrollment in an investigational drug or device study or participation in such a study within 6 months of entry into this study.
  31. Employee, or immediate relative of an employee, of the sponsor, any of its affiliates or partners, or the study center.
  32. 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): NCT03586427


Contacts
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Contact: Clinical Trial Registry Team IR-CTRegistration@Allergan.com

Locations
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United States, Arkansas
Health Initiatives Research PLLC Recruiting
Fayetteville, Arkansas, United States, 72703
United States, California
Synexus US - Cerritos Recruiting
Cerritos, California, United States, 90703
Wake Research - Pharmacology Research Institute Recruiting
Encino, California, United States, 91316
Wake Research - Pharmacology Research Institute Recruiting
Newport Beach, California, United States, 92660
Pacific Research Partners, LLC Recruiting
Oakland, California, United States, 94607
North County Clinical Research, Inc. Recruiting
Oceanside, California, United States, 92054
Collaborative Neuroscience Network Recruiting
Torrance, California, United States, 90502
Elite Clinical Trials, Inc. Recruiting
Wildomar, California, United States, 92595
United States, Georgia
Synexus US - Atlanta Recruiting
Atlanta, Georgia, United States, 30328
Atlanta Center for Medical Research Recruiting
Atlanta, Georgia, United States, 30331
United States, Illinois
Pillar Clinical Research Recruiting
Lincolnwood, Illinois, United States, 60712
United States, Massachusetts
Boston Clinical Trials Recruiting
Boston, Massachusetts, United States, 02131
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
Center for Emotional Fitness Recruiting
Cherry Hill, New Jersey, United States, 08002
United States, New York
Brooklyn Medical Institute Withdrawn
Brooklyn, New York, United States, 11214
Neurobehavioral Research, Inc Recruiting
Cedarhurst, New York, United States, 11516
Synexus US - Queens Recruiting
Jamaica, New York, United States, 11432
Eastside Comprehensive Medical Center Recruiting
New York, New York, United States, 10128
Finger Lakes Clinical Research Recruiting
Rochester, New York, United States, 14618
United States, Ohio
Neuro-Behavioral Clinical Research, Inc Recruiting
North Canton, Ohio, United States, 44720
United States, Tennessee
Clinical Neuroscience Solutions, Inc - Memphis, TN Recruiting
Memphis, Tennessee, United States, 38119
Research Strategies of Memphis, LLC Recruiting
Memphis, Tennessee, United States, 38119
United States, Texas
Donald J. Garcia, Jr., MD, PA Recruiting
Austin, Texas, United States, 78737
FutureSearch Trials of Dallas, LP Recruiting
Dallas, Texas, United States, 75231
United States, Washington
Northwest Clinical Research Center Recruiting
Bellevue, Washington, United States, 98007
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Raffaele Migliore Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03586427     History of Changes
Other Study ID Numbers: 3125-201-002
First Posted: July 13, 2018    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This is a phase 2 dose finding proof of concept study therefore data will not be shared.

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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