Adults 18 to 65, any sex, with Major Depressive Disorder. 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.
Change in the MADRS10 Total Score From Baseline to Day 28Primary· 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.
Group
Value
95% CI
REL-1017 25 mg
-15.1
± 11.3
Placebo
-12.9
± 10.4
MADRS10 Remission Rate (Total Score ≤10) at Day 28Secondary· 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.
Group
Value
95% CI
REL-1017 25 mg
22.1
15.5 – 30.6
Placebo
13.2
8.1 – 20.6
MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28Secondary· 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.
Group
Value
95% CI
REL-1017 25 mg
39.8
31.3 – 49.0
Placebo
27.2
19.9 – 36.0
Adverse events — posted to ClinicalTrials.gov
Time frame: TEAE that starts or worsens at any time after initiation of study drug collected up to 14 days post treatment (Day 42)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
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
NCT03051256 — Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
· Phase 2
· completed
Other recruiting trials for Major Depressive Disorder
Currently open trials in the same condition.
NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC
· NA
· recruiting
NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor
· Phase 2
· recruiting
NCT06749392 — An Individual-specific Synchrony Signature
· NA
· recruiting
NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness
· NA
· recruiting
NCT07242105 — Optimizing Brain Excitability in Depression
· NA
· recruiting
Other Relmada Therapeutics, Inc. trials
Trials by the same sponsor.
NCT07342517 — A Study of NDV-01 as an Intravesical Administration to Patients With BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
· Phase 3
· withdrawn
NCT07313891 — A Study of Adjuvant NDV-01 (Sustained-release Gemcitabine-docetaxel) for the Treatment of Intermediate Risk NMIBC Follow
· Phase 3
· withdrawn
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
NCT03051256 — Safety, Tolerability, PK Profile, and Symptom Response of a 7-Day Dosing With 25 mg or 50 mg Daily of REL-1017 in MDD
· Phase 2
· completed
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 27 August 2024
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/NCT04688164.