Trial Outcomes & Findings for A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder (NCT NCT06340958)
NCT ID: NCT06340958
Last Updated: 2026-06-23
Results Overview
The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
COMPLETED
PHASE2
99 participants
29 days
2026-06-23
Participant Flow
Participant milestones
| Measure |
CLE-100
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
|
Placebo
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
49
|
|
Overall Study
COMPLETED
|
40
|
42
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
CLE-100
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
|
Placebo
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Non compliance with study drug
|
1
|
1
|
|
Overall Study
Protocol specified withdrawal criterion met
|
1
|
0
|
Baseline Characteristics
A Study of CLE-100 (Oral Esketamine) as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
Baseline characteristics by cohort
| Measure |
CLE-100
n=50 Participants
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
|
Placebo
n=49 Participants
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Age, Continuous
|
45.30 years
STANDARD_DEVIATION 12.39 • n=20 Participants
|
43.86 years
STANDARD_DEVIATION 12.27 • n=20 Participants
|
44.59 years
STANDARD_DEVIATION 12.29 • n=40 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=20 Participants
|
33 Participants
n=20 Participants
|
66 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
78 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=20 Participants
|
35 Participants
n=20 Participants
|
74 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=20 Participants
|
49 participants
n=20 Participants
|
99 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 29 daysPopulation: Double-Blind Efficacy (DBE) Analysis Set, a subset of the Intention to treat (ITT) population
The MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Outcome measures
| Measure |
CLE-100
n=50 Participants
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
|
Placebo
n=49 Participants
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks.
|
|---|---|---|
|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Score
|
-11.66 units on a scale
Standard Error 1.50
|
-8.70 units on a scale
Standard Error 1.55
|
SECONDARY outcome
Timeframe: 29 daysThe CGI-S is a well-known and frequently used clinician-administered instrument for the assessment of MDD that weighs the clinical impact of the identified symptom(s) on behavior and function. The CGI-S grades measures of psychopathology on a scale from 1 to 7.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 weeksThe MADRS is a validated clinician-administered measurement of depression severity commonly used in clinical trials of depression treatments to select subjects and assess efficacy. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through study completion, an average of 7 monthsAssessment of the safety and tolerability of CLE-100 compared to placebo using the following assessments: * Adverse Events (AEs) * Adverse events of special interest (AESIs) * Clinical laboratory evaluations * Vital signs * 12-lead electrocardiogram * Modified Observer's Assessment of Alertness/Sedation scale (MOAA/S) * Clinician-Administered Dissociative State Scale (CADSS) * Incidence of suicidal ideation or behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) * 4-item Brief Psychiatric Rating Scale (BPRS) * 20-item Physician Withdrawal Checklist (PWC-20) * Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) * Digit Symbol Substitution Test (DSST) * Discontinuation rates and reason(s) for discontinuation
Outcome measures
Outcome data not reported
Adverse Events
CLE-100
Placebo
Serious adverse events
| Measure |
CLE-100
n=50 participants at risk
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
|
Placebo
n=49 participants at risk
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks
|
|---|---|---|
|
Investigations
Transaminases increased
|
2.0%
1/50 • 29 days double blind period plus 7 days follow up period
|
0.00%
0/49 • 29 days double blind period plus 7 days follow up period
|
Other adverse events
| Measure |
CLE-100
n=50 participants at risk
1 oral tablet of CLE-100 once daily (in addition to current anti-depressant drug) for 4 weeks
|
Placebo
n=49 participants at risk
1 oral tablet of Placebo once daily (in addition to current anti-depressant drug) for 4 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
18.0%
9/50 • 29 days double blind period plus 7 days follow up period
|
0.00%
0/49 • 29 days double blind period plus 7 days follow up period
|
|
Nervous system disorders
Dizziness
|
18.0%
9/50 • 29 days double blind period plus 7 days follow up period
|
4.1%
2/49 • 29 days double blind period plus 7 days follow up period
|
|
Nervous system disorders
Headache
|
12.0%
6/50 • 29 days double blind period plus 7 days follow up period
|
2.0%
1/49 • 29 days double blind period plus 7 days follow up period
|
|
Nervous system disorders
Brain fog
|
6.0%
3/50 • 29 days double blind period plus 7 days follow up period
|
0.00%
0/49 • 29 days double blind period plus 7 days follow up period
|
|
Psychiatric disorders
Dissociation
|
10.0%
5/50 • 29 days double blind period plus 7 days follow up period
|
2.0%
1/49 • 29 days double blind period plus 7 days follow up period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After the multicenter publication or 18 months after completion of the Study, whichever occurs first, Institution may itself publish the results of its data from the Study. Institution and Principal Investigator shall provide Sponsor with an advance copy of any proposed publication or oral presentation at least 60 days prior to the planned date of submission or presentation and Sponsor shall have 60 days to review the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER