Trial Outcomes & Findings for AGN-241751 in the Treatment of Major Depressive Disorder (NCT NCT03586427)
NCT ID: NCT03586427
Last Updated: 2022-08-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
251 participants
Primary outcome timeframe
Baseline to Day 1
Results posted on
2022-08-03
Participant Flow
After providing written consent, participants entered a single-blind placebo lead-in screening period of up to 7 days. Participants received single-blind placebo during the screening period. Participants meeting the eligibility criteria at the end of the screening period were randomized into one of the 5 treatment groups and entered the double-blind treatment period.
Participant milestones
| Measure |
AGN-241751 Dose 1
AGN-241751 Dose Level 1: 0.25 mg weekly for 3 weeks
|
AGN-241751 Dose 2
AGN-241751 Dose Level 2: 1 mg weekly for 3 weeks
|
AGN-241751 Dose 3
AGN-241751 Dose Level 3: 3 mg weekly for 3 weeks
|
AGN-241751 Dose 4
AGN-241751 Dose Level 4: 10 mg weekly for 3 weeks
|
Placebo
Placebo: Placebo administered weekly as a single tablet and daily to all groups except for drug day one time each week
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
48
|
50
|
52
|
50
|
51
|
|
Overall Study
COMPLETED
|
48
|
46
|
46
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
6
|
4
|
5
|
Reasons for withdrawal
| Measure |
AGN-241751 Dose 1
AGN-241751 Dose Level 1: 0.25 mg weekly for 3 weeks
|
AGN-241751 Dose 2
AGN-241751 Dose Level 2: 1 mg weekly for 3 weeks
|
AGN-241751 Dose 3
AGN-241751 Dose Level 3: 3 mg weekly for 3 weeks
|
AGN-241751 Dose 4
AGN-241751 Dose Level 4: 10 mg weekly for 3 weeks
|
Placebo
Placebo: Placebo administered weekly as a single tablet and daily to all groups except for drug day one time each week
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
1
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
1
|
|
Overall Study
Noncompliance with study drug
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
AGN-241751 in the Treatment of Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
AGN-241751 Dose 1
n=48 Participants
AGN-241751 0.25 mg administered as 1 tablet taken orally one time each week for 3 weeks
Placebo administered as 1 tablet taken orally every day except days AGN-214751 was taken
|
AGN-241751 Dose 2
n=50 Participants
AGN-241751 1 mg administered as 1 tablet taken orally one time each week for 3 weeks
Placebo administered as 1 tablet taken orally every day except days AGN-214751 was taken
|
AGN-241751 Dose 3
n=52 Participants
AGN-241751 3 mg administered as 1 tablet taken orally one time each week for 3 weeks
Placebo administered as 1 tablet taken orally every day except days AGN-214751 was taken
|
AGN-241751 Dose 4
n=50 Participants
AGN-241751 10 mg administered as 1 tablet taken orally one time each week for 3 weeks
Placebo administered as 1 tablet taken orally every day except days AGN-214751 was taken
|
Placebo
n=51 Participants
Placebo administered as 1 tablet taken orally every day
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 14.02 • n=5 Participants
|
41.8 years
STANDARD_DEVIATION 13.53 • n=7 Participants
|
42.2 years
STANDARD_DEVIATION 14.23 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 13.48 • n=4 Participants
|
40.0 years
STANDARD_DEVIATION 14.49 • n=21 Participants
|
41.7 years
STANDARD_DEVIATION 13.88 • n=10 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
114 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
137 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
99 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
135 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
50 participants
n=7 Participants
|
52 participants
n=5 Participants
|
50 participants
n=4 Participants
|
51 participants
n=21 Participants
|
251 participants
n=10 Participants
|
|
Current antidepressant usage
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
57 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 1The 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.
Outcome measures
| Measure |
AGN-241751 Dose 1
n=48 Participants
AGN-241751 Dose 1 administered as 1 tablet taken orally every day
AGN-241751: AGN-241751 administered orally as a single tablet
|
AGN-241751 Dose 2
n=50 Participants
AGN-241751 Dose 2 administered as 1 tablet taken orally every day
AGN-241751: AGN-241751 administered orally as a single tablet
|
AGN-241751 Dose 3
n=52 Participants
AGN-241751 Dose 3 administered as 1 tablet taken orally every day
AGN-241751: AGN-241751 administered orally as a single tablet
|
AGN-241751 Dose 4
n=50 Participants
AGN-241751 Dose 4 administered as 1 tablet taken orally every day
AGN-241751: AGN-241751 administered orally as a single tablet
|
Placebo
n=51 Participants
Placebo administered as 1 tablet taken orally every day
Placebo: Placebo administered orally as a single tablet
|
|---|---|---|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
|
-8.6 score on a scale
Standard Error 1.21
|
-8.0 score on a scale
Standard Error 1.19
|
-9.5 score on a scale
Standard Error 1.18
|
-10.6 score on a scale
Standard Error 1.18
|
-7.7 score on a scale
Standard Error 1.18
|
SECONDARY outcome
Timeframe: Baseline to Week 3The 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.
Outcome measures
| Measure |
AGN-241751 Dose 1
n=48 Participants
AGN-241751 Dose 1 administered as 1 tablet taken orally every day
AGN-241751: AGN-241751 administered orally as a single tablet
|
AGN-241751 Dose 2
n=50 Participants
AGN-241751 Dose 2 administered as 1 tablet taken orally every day
AGN-241751: AGN-241751 administered orally as a single tablet
|
AGN-241751 Dose 3
n=52 Participants
AGN-241751 Dose 3 administered as 1 tablet taken orally every day
AGN-241751: AGN-241751 administered orally as a single tablet
|
AGN-241751 Dose 4
n=50 Participants
AGN-241751 Dose 4 administered as 1 tablet taken orally every day
AGN-241751: AGN-241751 administered orally as a single tablet
|
Placebo
n=51 Participants
Placebo administered as 1 tablet taken orally every day
Placebo: Placebo administered orally as a single tablet
|
|---|---|---|---|---|---|
|
Change From Baseline in MADRS Total Score at Week 3
|
-11.5 score on a scale
Standard Error 1.56
|
-12.5 score on a scale
Standard Error 1.54
|
-14.1 score on a scale
Standard Error 1.55
|
-13.5 score on a scale
Standard Error 1.54
|
-13.6 score on a scale
Standard Error 1.54
|
Adverse Events
AGN-241751 Dose 1
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
AGN-241751 Dose 2
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
AGN-241751 Dose 3
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
AGN-241751 Dose 4
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AGN-241751 Dose 1
n=48 participants at risk
AGN-241751 Dose Level 1: 0.25 mg weekly for 3 weeks
|
AGN-241751 Dose 2
n=50 participants at risk
AGN-241751 Dose Level 2: 1 mg weekly for 3 weeks
|
AGN-241751 Dose 3
n=52 participants at risk
AGN-241751 Dose Level 3: 3 mg weekly for 3 weeks
|
AGN-241751 Dose 4
n=50 participants at risk
AGN-241751 Dose Level 4: 10 mg weekly for 3 weeks
|
Placebo
n=51 participants at risk
Placebo: Placebo administered weekly as a single tablet and daily to all groups except for drug day one time each week
|
|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
6.2%
3/48 • Number of events 3 • 4 weeks
|
6.0%
3/50 • Number of events 3 • 4 weeks
|
5.8%
3/52 • Number of events 3 • 4 weeks
|
4.0%
2/50 • Number of events 2 • 4 weeks
|
7.8%
4/51 • Number of events 4 • 4 weeks
|
|
Nervous system disorders
Somnolence
|
4.2%
2/48 • Number of events 2 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
0.00%
0/52 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
3.9%
2/51 • Number of events 2 • 4 weeks
|
|
Nervous system disorders
Dizziness
|
4.2%
2/48 • Number of events 2 • 4 weeks
|
0.00%
0/50 • 4 weeks
|
5.8%
3/52 • Number of events 3 • 4 weeks
|
6.0%
3/50 • Number of events 3 • 4 weeks
|
3.9%
2/51 • Number of events 2 • 4 weeks
|
|
Nervous system disorders
Sedation
|
4.2%
2/48 • Number of events 2 • 4 weeks
|
0.00%
0/50 • 4 weeks
|
0.00%
0/52 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
3.9%
2/51 • Number of events 2 • 4 weeks
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • Number of events 1 • 4 weeks
|
6.0%
3/50 • Number of events 3 • 4 weeks
|
3.8%
2/52 • Number of events 2 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
3.9%
2/51 • Number of events 2 • 4 weeks
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
4.2%
2/48 • Number of events 2 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
1.9%
1/52 • Number of events 1 • 4 weeks
|
4.0%
2/50 • Number of events 2 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.1%
1/48 • Number of events 1 • 4 weeks
|
4.0%
2/50 • Number of events 2 • 4 weeks
|
0.00%
0/52 • 4 weeks
|
4.0%
2/50 • Number of events 2 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Nervous system disorders
Insomnia
|
0.00%
0/48 • 4 weeks
|
10.0%
5/50 • Number of events 5 • 4 weeks
|
0.00%
0/52 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/48 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
0.00%
0/52 • 4 weeks
|
6.0%
3/50 • Number of events 3 • 4 weeks
|
2.0%
1/51 • Number of events 1 • 4 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
4.2%
2/48 • Number of events 2 • 4 weeks
|
0.00%
0/50 • 4 weeks
|
0.00%
0/52 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Infections and infestations
Viral Upper Respiratory Infection
|
4.2%
2/48 • Number of events 2 • 4 weeks
|
0.00%
0/50 • 4 weeks
|
0.00%
0/52 • 4 weeks
|
0.00%
0/50 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/48 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
5.8%
3/52 • Number of events 3 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/48 • 4 weeks
|
2.0%
1/50 • Number of events 1 • 4 weeks
|
0.00%
0/52 • 4 weeks
|
4.0%
2/50 • Number of events 2 • 4 weeks
|
0.00%
0/51 • 4 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60