Depression, Major Depressive Disorder
Conditions
Keywords
REL-1017, Relmada, NMDA Receptor Antagonist, Esmethadone, Adjunctive, Antidepressant, Reliance, Depression
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 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.
Interventions
DRUGREL-1017
REL-1017 tablet
DRUGPlacebo
Placebo tablet
Sponsors
Levomecor 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
* Body mass index (BMI) between 18.0 and 35.0 kg/m2. * Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD. * Current Major Depressive Episode (MDE). * Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with a depressant medication in the current MDE.
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. * Poorly controlled diabetes as defined by HbA1c \> 7.5%, despite standard care. Subjects with HbA1c \>7.5% may continue in the study if approved by the Relmada Medical Monitor. * Having received ketamine or esketamine within 60 days prior to Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 28 in MADRS Total Score | Baseline and Day 28 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 7 in MADRS Total Score | Day 7 | 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. |
| Change From Baseline to Day 28 in Clinical Global Impression-Severity (CGI-S) Score | Day 28 | Clinical Global Impression-Severity (CGI-S) is a clinician-rated assessment of illness severity. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Lower scores indicate less severe illness and a better outcome, whereas higher scores indicate more severe illness and a worse outcome. The outcome measure reports the change in CGI-S score from Baseline to Day 28. Change was calculated as Day 28 score minus Baseline score |
| MADRS10 Remission Rate at Day 28 | Day 28 | Remission was defined as a Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score ≤10 at Day 28. The MADRS total score ranges from 0 to 60, with lower scores indicating less severe depressive symptoms and a better outcome. |
| MADRS10 Response Rate at Day 28 | Day 28 | Response was defined as a ≥50% reduction from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score. The MADRS total score ranges from 0 to 60, with lower scores indicating less severe depressive symptoms and a better outcome. |
Countries
United States
Contacts
STUDY_DIRECTORPaul Greene, PhD
Relmada Therapeutics
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 236 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 194 Participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 119 | 0 / 117 |
| other Total, other adverse events | 47 / 119 | 57 / 117 |
| serious Total, serious adverse events | 0 / 119 | 0 / 117 |
Outcome results
None listed