Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REL-1017 | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REL-1017 | Drug | REL-1017 tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marco Pappagallo, MD | Relmada Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Relmada Site | Maitland | Florida | 32751 | United States | ||
| Relmada Site |
Not provided
| Label | URL |
|---|---|
| Study Homepage | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | REL-1017 | 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 |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo tablet |
|
| 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 | Day 28 |
| Miami |
| Florida |
| 33015 |
| United States |
| Relmada Site | Miami | Florida | 33175 | United States |
| Relmada Site | Miami Springs | Florida | 33166 | United States |
| Relmada Site | Orlando | Florida | 32801 | United States |
| Relmada Site | Palm Bay | Florida | 32905 | United States |
| Relmada Site | Chicago | Illinois | 60634 | United States |
| Relmada Site | Boston | Massachusetts | 02116 | United States |
| Relmada Site | Watertown | Massachusetts | 02472 | United States |
| Relmada Site | Austin | Texas | 78737 | United States |
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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | Day 28 |
|
|
| ||||||||||||||||||||||||||||
| 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. | 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 | Posted | Number | 95% Confidence Interval | percentage of participants in remission | Day 28 |
|
| |||||||||||||||||||||||||||||
| 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 | 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 | Posted | Number | 95% Confidence Interval | percentage of responders | Day 28 |
|
|
TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42).
A Treatment Emergent Adverse Event (TEAE) is defined as an Adverse Event (AE) that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42) as collected in the Safety Analysis Set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 116 | 0 | 116 | 39 | 116 |
| EG001 | 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 | 0 | 116 | 0 | 116 | 33 | 116 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 24.0 | Non-systematic Assessment |
| |
| Upper respirator tract infection | Infections and infestations | MedDRA 24.0 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Pappagallo, MD | Relmada Therapeutics | 786-638-7384 | info@relmada.com |
| Feb 16, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|