Adults 18 to 65, any sex, with Depressive Disorder, Major or Depressive Disorder, Treatment-Resistant. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of Treatment Emergent Adverse Events (AEs) [Safety and Tolerability]Primary· 21 days
Spontaneously reported or observed AEs will be recorded and reported throughout the study, and AEs will be elicited using a non-leading question at every visit from Screening through the Day 21 assessment.
An AE was any untoward medical occurrence in a patient or clinical investigation patient administered a pharmaceutical product and may not necessarily have a causal relationship with the administered treatment. An AE could therefore be any unfavorable and unintended sign (including a clinically significant laboratory abnormality, for example), symptom, or disease temporally associated with
All-causality TEAEs
Group
Value
95% CI
REL-1017 25 mg
9
REL-1017 50 mg
15
Placebo
12
All-causality SAEs
Group
Value
95% CI
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
ECG Parameters [Safety]Secondary· Screening, Day -1, Day 1 hour 2, 8, Day 2 hour 2, 8, Day 3-7 hour 2, Day 8, Day 9, and Day 14
12-Lead ECGs will be performed and reported at Screening; at Check In (Day -1); Days 1 through 9; and at Day 14.
Screening
Group
Value
95% CI
REL-1017 25 mg
14
REL-1017 50 mg
19
Placebo
16
REL-1017 25 mg
5
REL-1017 50 mg
2
Placebo
6
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Day -1 (Check-in)
Group
Value
95% CI
REL-1017 25 mg
17
REL-1017 50 mg
19
Placebo
20
REL-1017 25 mg
2
REL-1017 50 mg
2
Placebo
2
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Day 1, 2 hrs post-dose
Group
Value
95% CI
REL-1017 25 mg
16
REL-1017 50 mg
18
Placebo
20
REL-1017 25 mg
3
REL-1017 50 mg
3
Placebo
2
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Day 1, 8 hrs post-dose
Group
Value
95% CI
REL-1017 25 mg
15
REL-1017 50 mg
18
Placebo
20
REL-1017 25 mg
4
REL-1017 50 mg
3
Placebo
2
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Day 2, 2 hrs post-dose
Group
Value
95% CI
REL-1017 25 mg
15
REL-1017 50 mg
19
Placebo
20
REL-1017 25 mg
4
REL-1017 50 mg
2
Placebo
2
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Day 2, 8 hrs post-dose
Group
Value
95% CI
REL-1017 25 mg
15
REL-1017 50 mg
19
Placebo
19
REL-1017 25 mg
4
REL-1017 50 mg
2
Placebo
2
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Day 3, 2 hrs post-dose
Group
Value
95% CI
REL-1017 25 mg
14
REL-1017 50 mg
19
Placebo
18
REL-1017 25 mg
5
REL-1017 50 mg
2
Placebo
3
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Day 4, 2 hrs post-dose
Group
Value
95% CI
REL-1017 25 mg
15
REL-1017 50 mg
19
Placebo
19
REL-1017 25 mg
4
REL-1017 50 mg
2
Placebo
2
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Columbia Suicide Severity Rating Scale (C-SSRS) [Safety and Tolerability]Secondary· Day -1, Day 1, Day 2, Day 8, Day 9 and Day 14
The C-SSRS will be administered and reported at Screening and Check In (Day -1); and at Days 1, 2, 8, 9 and 14.
The C-SSRS is routinely used to quantify the severity of suicidal ideation and behavior. Both the ideation and behavior subscales are sensitive to change over time.
The scale identifies behaviors that may be indicative of an individual's intent to commit suicide. This measure contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month. Each question addresses a diffe
Participants with Suicidal Ideation (Any Score 1-5) : Day -1 (Check-in)
Group
Value
95% CI
REL-1017 25 mg
1
REL-1017 50 mg
0
Placebo
5
Participants with Suicidal Ideation (Any Score 1-5) : Day 1 (Baseline)
Group
Value
95% CI
REL-1017 25 mg
1
REL-1017 50 mg
0
Placebo
5
Participants with Suicidal Ideation (Any Score 1-5) : Day 2
Group
Value
95% CI
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Participants with Suicidal Ideation (Any Score 1-5) : Day 8
Group
Value
95% CI
REL-1017 25 mg
0
REL-1017 50 mg
1
Placebo
1
Participants with Suicidal Ideation (Any Score 1-5) : Day 9 (Discharge)
Group
Value
95% CI
REL-1017 25 mg
0
REL-1017 50 mg
1
Placebo
1
Participants with Suicidal Ideation (Any Score 1-5) : Day 14
Group
Value
95% CI
REL-1017 25 mg
1
REL-1017 50 mg
1
Placebo
1
Participants with Suicidal Behavior (any) : Day -1 (Check-in)
Group
Value
95% CI
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Participants with Suicidal Behavior (any) : Day 1 (Baseline)
Group
Value
95% CI
REL-1017 25 mg
0
REL-1017 50 mg
0
Placebo
0
Montgomery-Asberg Depression Scale (MADRS)Secondary· Change from Baseline to Day 7
Montgomery-Asberg Depression Scale (MADRS) will be administered and reported on Days 4, 7, and 14.
The MADRS questionnaire includes questions on the following symptoms: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts.
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. In Study REL-1017-202
Group
Value
95% CI
REL-1017 25 mg
-17.4
± 2.5
REL-1017 50 mg
-15.9
± 2.4
Placebo
-8.7
± 2.3
Montgomery-Asberg Depression Scale (MADRS)Secondary· Change from Baseline to Day 14
Montgomery-Asberg Depression Scale (MADRS) will be administered and reported on Days 4, 7, and 14.
The MADRS questionnaire includes questions on the following symptoms: (1) Apparent sadness; (2) Reported sadness; (3) Inner tension; (4) Reduced sleep; (5) Reduced appetite; (6) Concentration difficulties; (7) Lassitude; (8) Inability to feel; (9) Pessimistic thoughts; (10) Suicidal thoughts.
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. In Study REL-1017-202
Group
Value
95% CI
REL-1017 25 mg
-16.8
± 2.7
REL-1017 50 mg
-17.8
± 2.6
Placebo
-7.4
± 2.4
Symptoms of Depression Questionnaire (SDQ)Secondary· Change from Baseline to Day 7
Symptoms of Depression Questionnaire (SDQ) will be administered and reported on Days 4, 7, and 14.
The SDQ is a 44-item, self-report scale designed to measure the severity of symptoms across several subtypes of depression. The SDQ was developed to more fully capture the heterogeneity of symptom presentations of depressive disorders than current, widely used scales for MDD. The SDQ includes items that inquire about an extensive number of depressive symptoms beyond the ones included in other commonly used scales. The 44 SDQ items are rated on a 6-point scale. The total score is the sum of 44 it
Group
Value
95% CI
REL-1017 25 mg
-52.4
± 7.1
REL-1017 50 mg
-52.9
± 6.6
Placebo
-37.9
± 6.4
Symptoms of Depression Questionnaire (SDQ)Secondary· Change from Baseline to Day 14
Symptoms of Depression Questionnaire (SDQ) will be administered and reported on Days 4, 7, and 14.
The SDQ is a 44-item, self-report scale designed to measure the severity of symptoms across several subtypes of depression. The SDQ was developed to more fully capture the heterogeneity of symptom presentations of depressive disorders than current, widely used scales for MDD. The SDQ includes items that inquire about an extensive number of depressive symptoms beyond the ones included in other commonly used scales. The 44 SDQ items are rated on a 6-point scale. The total score is the sum of 44 it
Group
Value
95% CI
REL-1017 25 mg
-55.0
± 6.4
REL-1017 50 mg
-58.6
± 6.0
Placebo
-31.8
± 5.6
Clinical Global Impressions of Severity (CGI-S)Secondary· Change from Baseline to Day 7
Clinical Global Impressions of Severity (CGI-S) will be administered and reported on Days 4, 7, and 14.
The CGI-S is a standard method used in clinical studies to quantify and track patient progress and treatment response over time. The scale is composed of 7 ratings: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The score ranges from 1 to 7, and a lower CGI-S score indicates lower levels of depression.
Group
Value
95% CI
REL-1017 25 mg
-1.7
± 0.3
REL-1017 50 mg
-1.7
± 0.3
Placebo
-0.8
± 0.3
Clinical Global Impressions of Severity (CGI-S)Secondary· Change from Baseline to Day 14
Clinical Global Impressions of Severity (CGI-S) will be administered and reported on Days 4, 7, and 14.
The CGI-S is a standard method used in clinical studies to quantify and track patient progress and treatment response over time. The scale is composed of 7 ratings: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The score ranges from 1 to 7, and a lower CGI-S score indicates lower levels of depression.
Group
Value
95% CI
REL-1017 25 mg
-1.6
± 0.3
REL-1017 50 mg
-2.0
± 0.3
Placebo
-0.7
± 0.3
Clinical Global Impressions of Improvement (CGI-I)Secondary· Change from Baseline to Day 7
Clinical Global Impressions of Improvement (CGI-I) will be administered and reported at Days 4, 7 and 14.
The CGI-I is a standard method used in clinical studies to quantify and track patient change over time. The scale is composed of 7 ratings: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. The score ranges from 1 to 7, and a lower CGI-I score indicates greater improvement in symptoms.
Group
Value
95% CI
REL-1017 25 mg
2.4
± 0.2
REL-1017 50 mg
2.3
± 0.2
Placebo
3.2
± 0.2
Clinical Global Impressions of Improvement (CGI-I)Secondary· Change from Baseline to Day 14
Clinical Global Impressions of Improvement (CGI-I) will be administered and reported at Days 4, 7 and 14.
The CGI-I is a standard method used in clinical studies to quantify and track patient change over time. The scale is composed of 7 ratings: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; and 7 = very much worse. The score ranges from 1 to 7, and a lower CGI-I score indicates greater improvement in symptoms.
Group
Value
95% CI
REL-1017 25 mg
2.6
± 0.3
REL-1017 50 mg
2.3
± 0.3
Placebo
3.3
± 0.3
Maximum Observed Plasma Concentration (Cmax) [Pharmacokinetic]Secondary· Day 1 (hour -1, 1, 2, 4, 6, 8, 12, and 24)
The pharmacokinetic parameters of REL-1017 25 mg and 50 mg will be evaluated on Day 1 through Day 7, Day 8, Day 9, and Day 14 where the data allow.
Group
Value
95% CI
REL-1017 25 mg
254.5
± 60.864
REL-1017 50 mg
343.9
± 112.36
Adverse events — posted to ClinicalTrials.gov
Time frame: 21 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This a Phase 2a, multicenter, randomized, double-blind, placebo controlled 3 arm study to assess the safety and tolerability of multiple oral doses of REL-1017 25 mg and 50 mg as adjunctive therapy in the treatment of patients diagnosed with major depressive disorder (MDD). The patients will be adults with MDD who are diagnosed with a current MDE who have experienced an inadequate response to 1 to 3 courses of treatment with an antidepressant medication. This population will provide the opportunity to compare the safety and efficacy effects of treatment with an approved antidepressant in conjunction with REL-1017 versus the effects of an antidepressant alone. This study includes in-patient and out-patient periods.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06011577 — Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
· Phase 3
· terminated
NCT05081167 — A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
· Phase 3
· completed
NCT04855760 — Safety of REL-1017 for Major Depressive Disorder
· Phase 3
· completed
NCT04855747 — A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
· Phase 3
· terminated
NCT04688164 — A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
· Phase 3
· completed
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NCT05081167 — A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)
· Phase 3
· completed
NCT04855760 — Safety of REL-1017 for Major Depressive Disorder
· Phase 3
· completed
NCT04688164 — A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Relmada Therapeutics, Inc.
Last refreshed: 1 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03051256.