Trial Outcomes & Findings for A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD) (NCT NCT04688164)

Last Updated: 2024-08-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

227 participants

Primary outcome timeframe

Day 28

Results posted on

2024-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	113	114
Overall Study COMPLETED	106	99
Overall Study NOT COMPLETED	7	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	REL-1017 n=113 Participants 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. REL-1017: REL-1017 tablet	Placebo n=114 Participants 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. Placebo: Placebo tablet	Total n=227 Participants Total of all reporting groups
Age, Continuous	43.3 years STANDARD_DEVIATION 15.1 • n=5 Participants	43.6 years STANDARD_DEVIATION 14.2 • n=7 Participants	43.5 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants	87 Participants n=7 Participants	169 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	23 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants	85 Participants n=7 Participants	164 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) White	85 Participants n=5 Participants	90 Participants n=7 Participants	175 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and were assessed for the primary efficacy endpoint at both Baseline and Day 28

Outcome measures

Outcome measures
Measure	REL-1017 25 mg n=103 Participants 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. REL-1017: REL-1017 tablet	Placebo n=88 Participants 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. Placebo: Placebo tablet
Change in the MADRS10 Total Score From Baseline to Day 28	-15.1 score on a scale Standard Deviation 11.3	-12.9 score on a scale Standard Deviation 10.4

SECONDARY outcome

Timeframe: Day 28

Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and had the Baseline assessment of the primary efficacy endpoint performed

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.

Outcome measures

Outcome measures
Measure	REL-1017 25 mg n=113 Participants 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. REL-1017: REL-1017 tablet	Placebo n=114 Participants 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. Placebo: Placebo tablet
MADRS10 Remission Rate (Total Score ≤10) at Day 28	22.1 percentage of participants in remission Interval 15.5 to 30.6	13.2 percentage of participants in remission Interval 8.1 to 20.6

SECONDARY outcome

Timeframe: Day 28

Population: Full Analysis Set: defined as all subjects who received at least one dose of study medication and had the Baseline assessment of the primary efficacy endpoint performed

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.

Outcome measures

Outcome measures
Measure	REL-1017 25 mg n=113 Participants 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. REL-1017: REL-1017 tablet	Placebo n=114 Participants 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. Placebo: Placebo tablet
MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28	39.8 percentage of responders Interval 31.3 to 49.0	27.2 percentage of responders Interval 19.9 to 36.0

Adverse Events

REL-1017 25 mg

Serious events: 3 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	REL-1017 25 mg n=113 participants at risk 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. REL-1017: REL-1017 tablet	Placebo n=114 participants at risk 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. Placebo: Placebo tablet
Psychiatric disorders Suicidal Ideation	1.8% 2/113 • Number of events 2 • 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.	0.00% 0/114 • 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.
Hepatobiliary disorders Cholecystitis	0.88% 1/113 • Number of events 1 • 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.	0.00% 0/114 • 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.

Other adverse events

Other adverse events
Measure	REL-1017 25 mg n=113 participants at risk 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. REL-1017: REL-1017 tablet	Placebo n=114 participants at risk 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. Placebo: Placebo tablet
Nervous system disorders Headache	11.5% 13/113 • Number of events 15 • 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.	7.9% 9/114 • Number of events 11 • 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.
Infections and infestations COVID-19	5.3% 6/113 • Number of events 6 • 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.	8.8% 10/114 • Number of events 10 • 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.
Infections and infestations Upper respiratory tract infection	7.1% 8/113 • Number of events 9 • 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.	5.3% 6/114 • Number of events 6 • 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.
Gastrointestinal disorders Nausea	7.1% 8/113 • Number of events 9 • 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.	4.4% 5/114 • Number of events 5 • 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.
Gastrointestinal disorders Diarrhoea	4.4% 5/113 • Number of events 5 • 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.	6.1% 7/114 • Number of events 10 • 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.
Gastrointestinal disorders Constipation	2.7% 3/113 • Number of events 3 • 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.	6.1% 7/114 • Number of events 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.
Nervous system disorders Dizziness	6.2% 7/113 • Number of events 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.	1.8% 2/114 • Number of events 2 • 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.

Additional Information

Marco Pappagallo, MD

Relmada Therapeutics

Phone: 786-638-7384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place