A Two-Part, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose (Part A) or Twice Daily Dose (Part B) Study of AGN-241751 in Adult Participants With Major Depressive Disorder
Overview
- Phase
- Phase 1
- Intervention
- AGN-241751
- Conditions
- Major Depressive Disorder
- Sponsor
- Gate Neurosciences, Inc
- Enrollment
- 226
- Locations
- 5
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of AGN-241751 in participants with Major Depressive Disorder
Investigators
Eligibility 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
- •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.
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
- •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
Arms & Interventions
AGN-241751 3mg
AGN-241751, oral administration, once per day in Part A. Twice per day (BID) in Part B
Intervention: AGN-241751
AGN-241751 10mg
AGN-241751, oral administration, once per day
Intervention: AGN-241751
AGN-241751 25mg
AGN-241751, oral administration, once per day in Part A. Twice per day (BID) in Part B
Intervention: AGN-241751
Placebo
Placebo, oral administration, once per day in part A. Twice per day (BID) in Part B
Intervention: Placebo
Outcomes
Primary Outcomes
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
Time Frame: Baseline (Day1) to Day 2
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
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)
Time Frame: Baseline (Day 1) to Day 8
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.
Secondary Outcomes
- 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)