AGN-241751 in the Treatment of Major Depressive Disorder

NCT03726658 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 3125-104-002
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (2)

• Part A: Change in MADRS Score at 1 Day the Initial Dose of AGN-241751 Reported as Change From Baseline in Treated Group Compared With Change From Baseline in Placebo Group

  Efficacy will be measured by improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. The MADRS score ranges from 0 to 60 with a higher score indicating greater depression. A negative change score indicates improvement. Results are reported as change from baseline in treated group compared to change from baseline in placebo, reported as least squares difference and (standard error) calculated from a mixed model-repeated measures analysis

  Baseline (Day1) to Day 2

• Part B: Change From Baseline in MADRS Score at Day 8 Post the Initial Dose of AGN-241751 (i.e. 1 Day After the Seventh Daily Dose)

  Efficacy was measured by improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score. The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. The MADRS score ranges from 0 to 60 with a higher score indicating greater depression. A negative change score indicates improvement.

  Baseline (Day 1) to Day 8

Secondary Outcomes (2)

• Part A: Change From Baseline in MADRS Score on Day 9 and Day 15 of AGN-241751 Once Daily and at Day 22 (7 Days After Completion of AGN-241751 Dosing) Compared With Change in Placebo

  Baseline (Day 1) to Day 22

• Part B: Change From Baseline in MADRS Score on Day 11, Day 14, and Day 18 of AGN-241751 Administered Two Times Daily and on Day 21 (7 Days After Completion of Dosing) in Treated Group Compared to Change From Baseline in Placebo Group

  Baseline (Day 1) to Day 21

Study Arms (4)

AGN-241751 3mg

EXPERIMENTAL

AGN-241751, oral administration, once per day in Part A. Twice per day (BID) in Part B

Drug: AGN-241751

AGN-241751 10mg

EXPERIMENTAL

AGN-241751, oral administration, once per day

Drug: AGN-241751

AGN-241751 25mg

EXPERIMENTAL

AGN-241751, oral administration, once per day in Part A. Twice per day (BID) in Part B

Drug: AGN-241751

Placebo

PLACEBO COMPARATOR

Placebo, oral administration, once per day in part A. Twice per day (BID) in Part B

Drug: Placebo

Interventions

AGN-241751 DRUG

AGN-241751 is supplied in tablet form

AGN-241751 10mg; AGN-241751 25mg; AGN-241751 3mg

Placebo DRUG

Placebo is supplied in tablet form

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 at screening (Visit 1) 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Syndeio Biosciences, Inc: lead

Study Sites (5)

Alea Research

Phoenix, Arizona, 85012, United States

Location

Collaborative Neuroscience Network, LLC

Garden Grove, California, 92845, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08809, United States

Location

Northwest Clinical Research Center

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Gate Neurosciences, Inc

ron.burch@gateneuro.com

203-247-3895

Study Officials

• Ronald M Burch, MD PhD

  Syndeio Biosciences, Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: October 31, 2018
• Study Start: November 8, 2018
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: July 7, 2023
• Results First Posted: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)