Trial Outcomes & Findings for Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD (NCT NCT06011577)

Last Updated: 2026-07-10

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

27 participants

Primary outcome timeframe

Baseline and Day 28

Results posted on

2026-07-10

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	14	13
Overall Study COMPLETED	13	13
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
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 Study terminated by Sponsor	1	0

Baseline Characteristics

Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	REL-1017 n=14 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 (ADT). REL-1017: REL-1017 tablet	Placebo n=13 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 (ADT). Placebo: Placebo tablet	Total n=27 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Age, Categorical <=18 years	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=9 Participants	13 Participants n=27 Participants	27 Participants n=267 Participants
Age, Categorical >=65 years	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Sex: Female, Male Female	12 Participants n=9 Participants	10 Participants n=27 Participants	22 Participants n=267 Participants
Sex: Female, Male Male	2 Participants n=9 Participants	3 Participants n=27 Participants	5 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	1 Participants n=27 Participants	1 Participants n=267 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	1 Participants n=27 Participants	1 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) White	14 Participants n=9 Participants	11 Participants n=27 Participants	25 Participants n=267 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=9 Participants	6 Participants n=27 Participants	14 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=9 Participants	7 Participants n=27 Participants	13 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
MADRS10 at baseline	34.2 Scores on a scale (MADRS10) STANDARD_DEVIATION 4.41 • n=9 Participants	32.3 Scores on a scale (MADRS10) STANDARD_DEVIATION 3.73 • n=27 Participants	33.3 Scores on a scale (MADRS10) STANDARD_DEVIATION 4.13 • n=267 Participants

PRIMARY outcome

Timeframe: Baseline and Day 28

Outcome measures

Outcome measures
Measure	Placebo n=13 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 (ADT). Placebo: Placebo tablet	REL-1017 n=14 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 (ADT). REL-1017: REL-1017 tablet
Change From Baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	-13.4 Scores on a scale (MADRS10) Standard Deviation 9.55	-16.8 Scores on a scale (MADRS10) Standard Deviation 7.62

SECONDARY outcome

Timeframe: Baseline and 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.

Outcome measures

Outcome measures
Measure	Placebo n=13 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 (ADT). Placebo: Placebo tablet	REL-1017 n=14 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 (ADT). REL-1017: REL-1017 tablet
Change From Baseline to Day 7 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score	-5.1 MADRS10 score Standard Deviation 5.66	-8.9 MADRS10 score Standard Deviation 6.84

Adverse Events

REL-1017

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Scientific Officer

Levomecor Inc.

Phone: +16462843119

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	REL-1017 n=14 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 (ADT). REL-1017: REL-1017 tablet	Placebo n=13 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 (ADT). Placebo: Placebo tablet
Infections and infestations Urinary tract infection	14.3% 2/14 • 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.	7.7% 1/13 • 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.
Metabolism and nutrition disorders Decrease Appetite/Poor Appetite	7.1% 1/14 • 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% 0/13 • 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 Dry Mouth	7.1% 1/14 • 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% 0/13 • 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.
General disorders Fatigue/Tireness	7.1% 1/14 • 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% 0/13 • 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 Dysgeusia/Aluminum taste in the mouth	7.1% 1/14 • 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% 0/13 • 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.
Skin and subcutaneous tissue disorders Pruritus/Itching all over the body	7.1% 1/14 • 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% 0/13 • 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 Disness/ Light headacheness	7.1% 1/14 • 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% 0/13 • 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 Abdominal distention/ Bloating	7.1% 1/14 • 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% 0/13 • 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% 1/14 • 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% 0/13 • 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 Headache	7.1% 1/14 • 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% 0/13 • 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 Migraine Headache	7.1% 1/14 • 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% 0/13 • 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 Vomiting	7.1% 1/14 • 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% 0/13 • 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 Influenza	7.1% 1/14 • 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% 0/13 • 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.
Renal and urinary disorders Dysuria	7.1% 1/14 • 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% 0/13 • 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	7.1% 1/14 • 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% 0/13 • 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.
Musculoskeletal and connective tissue disorders Backpain	7.1% 1/14 • 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% 0/13 • 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 Nasopharyngitis/ Common cold	7.1% 1/14 • 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.	7.7% 1/13 • 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.
Psychiatric disorders Initial Insomnia	7.1% 1/14 • 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% 0/13 • 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.
Vascular disorders Hypertension	7.1% 1/14 • 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% 0/13 • 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/ Upper Respiratory Infection	7.1% 1/14 • 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% 0/13 • 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	0.00% 0/14 • 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.	7.7% 1/13 • 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.