A Phase 3 interventional study of REL-1017 and Placebo in Major Depressive Disorder, sponsored by Relmada Therapeutics, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Relmada Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's enrollment of 227 is above the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Relmada Therapeutics, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: REL-1017
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.
Drug: Placebo
REL-1017 tablet
Also known as: esmethadone
Placebo tablet
Change in the MADRS10 Total Score From Baseline to Day 28
Therapeutic efficacy of REL-1017 as adjunctive treatment 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
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
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
| Milestone | REL-1017 | Placebo |
|---|---|---|
| Started | 113 | 114 |
| Completed | 106 | 99 |
| Not completed | 7 | 15 |
Therapeutic efficacy of REL-1017 as adjunctive treatment 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.
| score on a scale | REL-1017 25 mg | Placebo |
|---|---|---|
| Change in the MADRS10 Total Score From Baseline to Day 28 | -15.1 ± 11.3 | -12.9 ± 10.4 |
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.
| percentage of participants in remission | REL-1017 25 mg | Placebo |
|---|---|---|
| MADRS10 Remission Rate (Total Score ≤10) at Day 28 | 22.1 (15.5 to 30.6) | 13.2 (8.1 to 20.6) |
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.
| percentage of responders | REL-1017 25 mg | Placebo |
|---|---|---|
| MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28 | 39.8 (31.3 to 49.0) | 27.2 (19.9 to 36.0) |
Collected over TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| REL-1017 25 mg | 0/113 (0%) | 3/113 (2.7%) | 34/113 (30.1%) |
| Placebo | 0/114 (0%) | 0/114 (0%) | 34/114 (29.8%) |
| Event | REL-1017 25 mg | Placebo |
|---|---|---|
| Suicidal IdeationPsychiatric disorders | 2/113 | 0/114 |
| CholecystitisHepatobiliary disorders | 1/113 | 0/114 |
| Event | REL-1017 25 mg | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 13/113 | 9/114 |
| COVID-19Infections and infestations | 6/113 | 10/114 |
| Upper respiratory tract infectionInfections and infestations | 8/113 | 6/114 |
| NauseaGastrointestinal disorders | 8/113 | 5/114 |
| DizzinessNervous system disorders | 7/113 | 2/114 |
| DiarrhoeaGastrointestinal disorders | 5/113 | 7/114 |
| ConstipationGastrointestinal disorders | 3/113 | 7/114 |
| Age, Continuous(years) | REL-1017 | Placebo | Total |
|---|---|---|---|
| Mean | 43.3 ± 15.1 | 43.6 ± 14.2 | 43.5 ± 14.6 |
| Sex: Female, Male(Participants) | REL-1017 | Placebo | Total |
|---|---|---|---|
| Female | 82 | 87 | 169 |
| Male | 31 | 27 | 58 |
| Ethnicity (NIH/OMB)(Participants) | REL-1017 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 29 | 23 | 52 |
| Not Hispanic or Latino | 79 | 85 | 164 |
| Unknown or Not Reported | 5 | 6 | 11 |
| Race (NIH/OMB)(Participants) | REL-1017 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 7 | 13 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 14 | 30 |
| White | 85 | 90 | 175 |
| More than one race | 4 | 2 | 6 |
| Unknown or Not Reported | 2 | 1 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: D-methadone
Relmada Therapeutics, Inc.