Major Depressive Disorder
Conditions
Keywords
REL-1017
Brief summary
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as a monotherapy for Major Depressive Disorder.
Interventions
DRUGREL-1017
REL-1017 tablet
DRUGPlacebo
Placebo tablet
Sponsors
Relmada Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults 18 to 65 years, inclusive. * Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD. * Current major depressive episode.
Exclusion criteria
* Any current and primary psychiatric disorder other than Major Depressive Disorder. * Severe alcohol or substance use disorder. * History of bipolar I and II disorder, psychosis, and/or mania. * Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study. * Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the MADRS10 Total Score From Baseline to Day 28 | Day 28 | Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MADRS10 Remission Rate (Total Score ≤10) at Day 28 | Day 28 | Therapeutic remission rate with REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Remission is defined as MADRS10 Total Score ≤10 at Day 28. A higher percentage of remission indicates a higher percentage of subjects with MADRS10 Total Score ≤10 at Day 28. |
| MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28 | Day 28 | Therapeutic response to REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Response rate is defined as an improvement ≥50% compared with total Baseline MADRS10 score |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| REL-1017 25 mg A 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017.
REL-1017: REL-1017 tablet | 116 |
| Placebo Three tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet.
Placebo: Placebo tablet | 116 |
| Total | 232 |
Baseline characteristics
| Characteristic | REL-1017 25 mg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 36.2 years STANDARD_DEVIATION 13 | 38.7 years STANDARD_DEVIATION 12.9 | 37.4 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 46 Participants | 36 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 68 Participants | 78 Participants | 146 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 7 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 23 Participants | 43 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) White | 81 Participants | 84 Participants | 165 Participants |
| Sex: Female, Male Female | 83 Participants | 71 Participants | 154 Participants |
| Sex: Female, Male Male | 33 Participants | 45 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 116 | 0 / 116 |
| other Total, other adverse events | 39 / 116 | 33 / 116 |
| serious Total, serious adverse events | 0 / 116 | 0 / 116 |
Outcome results
Primary
Change in the MADRS10 Total Score From Baseline to Day 28
Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement.
Time frame: Day 28
Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and were assessed for the primary efficacy endpoint at both Baseline and Day 28
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REL-1017 25 mg | Change in the MADRS10 Total Score From Baseline to Day 28 | -14.8 score on a scale | Standard Deviation 12.4 |
| Placebo | Change in the MADRS10 Total Score From Baseline to Day 28 | -13.9 score on a scale | Standard Deviation 10.8 |
Secondary
MADRS10 Remission Rate (Total Score ≤10) at Day 28
Therapeutic remission rate with REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Remission is defined as MADRS10 Total Score ≤10 at Day 28. A higher percentage of remission indicates a higher percentage of subjects with MADRS10 Total Score ≤10 at Day 28.
Time frame: Day 28
Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and had the Baseline assessment of the primary efficacy endpoint performed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REL-1017 25 mg | MADRS10 Remission Rate (Total Score ≤10) at Day 28 | 21.6 percentage of participants in remission |
| Placebo | MADRS10 Remission Rate (Total Score ≤10) at Day 28 | 16.4 percentage of participants in remission |
Secondary
MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28
Therapeutic response to REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10). Response rate is defined as an improvement ≥50% compared with total Baseline MADRS10 score
Time frame: Day 28
Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and had the Baseline assessment of the primary efficacy endpoint performed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| REL-1017 25 mg | MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28 | 38.8 percentage of responders |
| Placebo | MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28 | 34.5 percentage of responders |