Not provided
Not provided
Not provided
Not provided
Study REL-1017-304 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation conducted in study REL-1017-302. Safety assessments were performed in both studies in accordance with the study protocols
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
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 an adjunctive treatment of Major Depressive Disorder in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REL-1017 25 mg | Experimental | During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT) |
|
| Placebo | Placebo Comparator | During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REL-1017 | Drug | REL-1017 tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score. | Baseline and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 7 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 7.Change was calculated as Day 7 score minus Baseline score. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul Greene, PhD | Relmada Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Relmada Site | Dothan | Alabama | 36303 | 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 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Jul 10, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo tablet |
|
| Baseline and Day 7 |
| Homewood |
| Alabama |
| 35209 |
| United States |
| Relmada Site | Anaheim | California | 92805 | United States |
| Relmada Site | Lafayette | California | 94549 | United States |
| Relmada Site | Newport Beach | California | 92660 | United States |
| Relmada Site | Orange | California | 92868 | United States |
| Relmada Site | Redlands | California | 92374 | United States |
| Relmada Site | Sherman Oaks | California | 91403 | United States |
| Relmada Site | Farmington | Connecticut | 06030 | United States |
| Relmada Site | Brandon | Florida | 33511 | United States |
| Relmada Site | Hialeah | Florida | 33027 | United States |
| Relmada Site | Jacksonville | Florida | 32256 | United States |
| Relmada Site | Miami | Florida | 33133 | United States |
| Relmada Site | Miami | Florida | 33174 | United States |
| Relmada Site | Okeechobee | Florida | 34972 | United States |
| Relmada Site | Tampa | Florida | 33607 | United States |
| Relmada Site | Springfield | Illinois | 62794 | United States |
| Relmada Site | Baltimore | Maryland | 21208 | United States |
| Relmada Site | Mankato | Minnesota | 56001 | United States |
| Relmada Site | Toms River | New Jersey | 08755 | United States |
| Relmada Site | Brooklyn | New York | 11235 | United States |
| Relmada Site | Cedarhurst | New York | 11516 | United States |
| Relmada Site | New York | New York | 10036 | United States |
| Relmada Site | Philadelphia | Pennsylvania | 19104 | United States |
| Relmada Site | Franklin | Tennessee | 37067 | United States |
| Relmada Site | Memphis | Tennessee | 38119 | United States |
| Relmada Site | Austin | Texas | 78712 | United States |
| Relmada Site | Bellaire | Texas | 77401 | United States |
| Relmada Site | Friendswood | Texas | 77546 | United States |
| Relmada Site | Houston | Texas | 77030 | United States |
| Relmada Site | Wichita Falls | Texas | 76309 | United States |
| Relmada Site | Clinton | Utah | 84015 | United States |
| Relmada Site | Draper | Utah | 84020 | United States |
| Relmada Site | Rutland | Vermont | 05701 | United States |
| Relmada Site | Charlottesville | Virginia | 22903 | United States |
| Relmada Site | Seattle | Washington | 98104 | 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 in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 in addition to their ongoing antidepressant (ADT). 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 in addition to their ongoing antidepressant (ADT). 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| MADRS10 at baseline | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. | Mean | Standard Deviation | Scores on a scale (MADRS10) |
|
| 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 From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score. | Posted | Mean | Standard Deviation | Scores on a scale (MADRS10) | Baseline and Day 28 |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 7 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score | Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. The total score is calculated as the sum of 10 items, each scored from 0 to 6, resulting in a total score range of 0 to 60. Lower scores indicate less severe depressive symptoms and a better outcome, whereas higher scores indicate more severe depressive symptoms and a worse outcome. The outcome measure reports the change in MADRS total score from Baseline to Day 7.Change was calculated as Day 7 score minus Baseline score. | Posted | Mean | Standard Deviation | MADRS10 score | Baseline and Day 7 |
|
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 | 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 in addition to their ongoing antidepressant (ADT). REL-1017: REL-1017 tablet | 0 | 14 | 0 | 14 | 9 | 14 |
| 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 in addition to their ongoing antidepressant (ADT). Placebo: Placebo tablet | 0 | 13 | 0 | 13 | 3 | 13 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Decrease Appetite/Poor Appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Fatigue/Tireness | General disorders | Non-systematic Assessment |
| ||
| Dysgeusia/Aluminum taste in the mouth | Nervous system disorders | Non-systematic Assessment |
| ||
| Pruritus/Itching all over the body | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Disness/ Light headacheness | Nervous system disorders | Non-systematic Assessment |
| ||
| Abdominal distention/ Bloating | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Migraine Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Backpain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Nasopharyngitis/ Common cold | Infections and infestations | Non-systematic Assessment |
| ||
| Initial Insomnia | Psychiatric disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Upper Respiratory Tract Infection/ Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
Study REL-1017-304 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation conducted in study REL-1017-302. Safety assessments were performed in both studies in accordance with the study protocols.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Scientific Officer | Levomecor Inc. | +16462843119 | administration@levomecor.com |
| Jun 15, 2026 |
| Prot_SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|