Trial Outcomes & Findings for Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD) (NCT NCT05686408)
NCT ID: NCT05686408
Last Updated: 2025-02-17
Results Overview
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
132 participants
Primary outcome timeframe
Day 1 and Week 6
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablet taken orally once daily for 6 weeks.
Placebo: Patients will take 1 tablet orally once daily for 6 weeks.
|
TNX-601 ER, 39.4 mg
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
TNX-601 ER: Patients will take 1 tablet orally once daily for 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
64
|
|
Overall Study
COMPLETED
|
58
|
53
|
|
Overall Study
NOT COMPLETED
|
10
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Evaluate TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
Placebo
n=68 Participants
Placebo tablet taken orally once daily for 6 weeks.
Placebo: Patients will take 1 tablet orally once daily for 6 weeks.
|
TNX-601 ER, 39.4 mg
n=64 Participants
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
TNX-601 ER: Patients will take 1 tablet orally once daily for 6 weeks.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.8 years
STANDARD_DEVIATION 13.87 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 11.92 • n=7 Participants
|
41.0 years
STANDARD_DEVIATION 12.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
56 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
44 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
64 participants
n=7 Participants
|
132 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 and Week 6Population: Results reported for ITT population, which includes all randomized patients who received at least one dose of IP.
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo tablet taken orally once daily for 6 weeks.
Placebo: Patients will take 1 tablet orally once daily for 6 weeks.
|
TNX-601 ER, 39.4 mg
n=64 Participants
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
TNX-601 ER: Patients will take 1 tablet orally once daily for 6 weeks.
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
-12.8 units on a scale
Standard Error 1.32
|
-12.7 units on a scale
Standard Error 1.30
|
SECONDARY outcome
Timeframe: Day 1 and Week 6Population: Results reported for ITT population, which includes all randomized patients who received at least one dose of IP.
Change from Baseline (Visit 2) in the Clinical Global Impression of Severity Scale (CGI-S) score at Week 6. Scores range from 1 to 7. Lower scores indicate less severe illness.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo tablet taken orally once daily for 6 weeks.
Placebo: Patients will take 1 tablet orally once daily for 6 weeks.
|
TNX-601 ER, 39.4 mg
n=64 Participants
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
TNX-601 ER: Patients will take 1 tablet orally once daily for 6 weeks.
|
|---|---|---|
|
Clinical Global Impression of Severity (CGI-S)
|
-1.2 units on a scale
Standard Error 0.16
|
-1.0 units on a scale
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Day 1 and Week 6Population: Results reported for ITT population, which includes all randomized patients who received at least one dose of IP.
Change from Baseline (Visit 2) in the Sheehan Disability Scale (SDS) total score at Week 6. Scores range from 0 to 30. Lower scores indicate less impairment to activities.
Outcome measures
| Measure |
Placebo
n=68 Participants
Placebo tablet taken orally once daily for 6 weeks.
Placebo: Patients will take 1 tablet orally once daily for 6 weeks.
|
TNX-601 ER, 39.4 mg
n=64 Participants
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
TNX-601 ER: Patients will take 1 tablet orally once daily for 6 weeks.
|
|---|---|---|
|
Sheehan Disability Scale (SDS)
|
-7.3 units on a scale
Standard Error 0.97
|
-5.8 units on a scale
Standard Error 0.95
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
TNX-601 ER, 39.4 mg
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=68 participants at risk
Placebo tablet taken orally once daily for 6 weeks.
Placebo: Patients will take 1 tablet orally once daily for 6 weeks.
|
TNX-601 ER, 39.4 mg
n=64 participants at risk
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
TNX-601 ER: Patients will take 1 tablet orally once daily for 6 weeks.
|
|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/68 • 8 weeks
|
1.6%
1/64 • 8 weeks
|
|
Nervous system disorders
Generalized tonic-clonic seizure
|
0.00%
0/68 • 8 weeks
|
1.6%
1/64 • 8 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/68 • 8 weeks
|
1.6%
1/64 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
1.5%
1/68 • 8 weeks
|
0.00%
0/64 • 8 weeks
|
Other adverse events
| Measure |
Placebo
n=68 participants at risk
Placebo tablet taken orally once daily for 6 weeks.
Placebo: Patients will take 1 tablet orally once daily for 6 weeks.
|
TNX-601 ER, 39.4 mg
n=64 participants at risk
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
TNX-601 ER: Patients will take 1 tablet orally once daily for 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.4%
3/68 • 8 weeks
|
10.9%
7/64 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee An industry standard NDA is in place with all investigators.
- Publication restrictions are in place
Restriction type: OTHER