Trial Outcomes & Findings for Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD (NCT NCT05165394)
NCT ID: NCT05165394
Last Updated: 2024-07-31
Results Overview
The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68.
COMPLETED
PHASE2
93 participants
Baseline, Day 57
2024-07-31
Participant Flow
Participant milestones
| Measure |
Placebo
Participant follows placebo schedule (57 days).
|
NBI-1065846
Participant follows NBI-1065846 schedule (57 days).
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
46
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
47
|
46
|
|
Overall Study
COMPLETED
|
41
|
42
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Participant follows placebo schedule (57 days).
|
NBI-1065846
Participant follows NBI-1065846 schedule (57 days).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Other Than Specified
|
0
|
1
|
Baseline Characteristics
Study to Evaluate the Efficacy and Safety of Once-Weekly Oral NBI-1065846 in the Treatment of Anhedonia in MDD
Baseline characteristics by cohort
| Measure |
Placebo
n=47 Participants
Participant follows placebo schedule (57 days).
|
NBI-1065846
n=46 Participants
Participant follows NBI-1065846 schedule (57 days).
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.3 years
STANDARD_DEVIATION 12.8 • n=93 Participants
|
43.8 years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
43.1 years
STANDARD_DEVIATION 13.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=93 Participants
|
37 Participants
n=4 Participants
|
77 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
4 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
36 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Dimensional Anhedonia Rating Scale (DARS) Score
|
15.1 units on a scale
STANDARD_DEVIATION 10.5 • n=93 Participants
|
18.7 units on a scale
STANDARD_DEVIATION 12.8 • n=4 Participants
|
16.9 units on a scale
STANDARD_DEVIATION 11.8 • n=27 Participants
|
|
Total Montgomery Åsberg Depression Rating Scale (MADRS) Score
|
30.8 units on a scale
STANDARD_DEVIATION 6.6 • n=93 Participants
|
31.0 units on a scale
STANDARD_DEVIATION 5.5 • n=4 Participants
|
30.9 units on a scale
STANDARD_DEVIATION 6.1 • n=27 Participants
|
|
Clinical Global Impression - Severity (CGI-S)
|
4.7 units on a scale
STANDARD_DEVIATION 0.7 • n=93 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.6 • n=4 Participants
|
4.8 units on a scale
STANDARD_DEVIATION 0.7 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 57Population: Full Analysis Set (FAS): All randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for specified outcome measure.
The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participant follows placebo schedule (57 days).
|
NBI-1065846
n=45 Participants
Participant follows NBI-1065846 schedule (57 days).
|
|---|---|---|
|
Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57
|
17.4 units on a scale
Standard Error 3.7
|
13.5 units on a scale
Standard Error 3.6
|
SECONDARY outcome
Timeframe: Baseline, Day 57Population: FAS: All randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for specified outcome measure.
The MADRS is a validated rating scale designed to measure changes in the severity of depressive symptoms. The MADRS consists of 10 items scored on a 7-point scale (0 to 6). Higher MADRS scores indicate more severe depression. The MADRS total score was calculated as the sum of the 10 individual item scores which ranges from 0 to 60.
Outcome measures
| Measure |
Placebo
n=31 Participants
Participant follows placebo schedule (57 days).
|
NBI-1065846
n=33 Participants
Participant follows NBI-1065846 schedule (57 days).
|
|---|---|---|
|
Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression
|
-13.9 units on a scale
Standard Error 3.4
|
-15.1 units on a scale
Standard Error 3.0
|
SECONDARY outcome
Timeframe: Baseline and Day 57Population: FAS: All randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for specified outcome measure. Number analyzed = number of participants with evaluable data at the specified timepoint.
The CGI-S scale, which is based on a 7-point scale (range: 1=normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = extremely ill), was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Outcome measures
| Measure |
Placebo
n=46 Participants
Participant follows placebo schedule (57 days).
|
NBI-1065846
n=45 Participants
Participant follows NBI-1065846 schedule (57 days).
|
|---|---|---|
|
CGI-S Scores
Baseline: Normal, not at all ill (1)
|
0 Participants
|
0 Participants
|
|
CGI-S Scores
Baseline: Borderline ill (2)
|
0 Participants
|
0 Participants
|
|
CGI-S Scores
Baseline: Mildly ill (3)
|
1 Participants
|
1 Participants
|
|
CGI-S Scores
Baseline: Moderately ill (4)
|
16 Participants
|
11 Participants
|
|
CGI-S Scores
Baseline: Markedly ill (5)
|
23 Participants
|
26 Participants
|
|
CGI-S Scores
Baseline: Severely ill (6)
|
6 Participants
|
4 Participants
|
|
CGI-S Scores
Baseline: Extremely ill (7)
|
0 Participants
|
0 Participants
|
|
CGI-S Scores
Day 57: Normal, not at all ill (1)
|
6 Participants
|
7 Participants
|
|
CGI-S Scores
Day 57: Borderline ill (2)
|
7 Participants
|
7 Participants
|
|
CGI-S Scores
Day 57: Mildly ill (3)
|
12 Participants
|
11 Participants
|
|
CGI-S Scores
Day 57: Moderately ill (4)
|
10 Participants
|
12 Participants
|
|
CGI-S Scores
Day 57: Markedly ill (5)
|
9 Participants
|
7 Participants
|
|
CGI-S Scores
Day 57: Severely ill (6)
|
0 Participants
|
1 Participants
|
|
CGI-S Scores
Day 57: Extremely ill (7)
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo
NBI-1065846
Serious adverse events
| Measure |
Placebo
n=47 participants at risk
Participant follows placebo schedule (57 days).
|
NBI-1065846
n=46 participants at risk
Participant follows NBI-1065846 schedule (57 days).
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
2.1%
1/47 • Day 1 (after dosing) through Day 106
Safety Analysis Set: All randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to their randomized treatment group, unless they received the incorrect study treatment for the entire treatment duration. Time frame includes treatment period (Days 1 to 57) and safety follow-up period (up to Day 106).
|
0.00%
0/46 • Day 1 (after dosing) through Day 106
Safety Analysis Set: All randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to their randomized treatment group, unless they received the incorrect study treatment for the entire treatment duration. Time frame includes treatment period (Days 1 to 57) and safety follow-up period (up to Day 106).
|
Other adverse events
| Measure |
Placebo
n=47 participants at risk
Participant follows placebo schedule (57 days).
|
NBI-1065846
n=46 participants at risk
Participant follows NBI-1065846 schedule (57 days).
|
|---|---|---|
|
Nervous system disorders
Headache
|
8.5%
4/47 • Day 1 (after dosing) through Day 106
Safety Analysis Set: All randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to their randomized treatment group, unless they received the incorrect study treatment for the entire treatment duration. Time frame includes treatment period (Days 1 to 57) and safety follow-up period (up to Day 106).
|
6.5%
3/46 • Day 1 (after dosing) through Day 106
Safety Analysis Set: All randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to their randomized treatment group, unless they received the incorrect study treatment for the entire treatment duration. Time frame includes treatment period (Days 1 to 57) and safety follow-up period (up to Day 106).
|
Additional Information
Neurocrine Medical Information Call Center
Neurocrine Biosciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place