A Study to Assess the Efficacy and Safety of REL-1017 as... | NCT04855747

NCT04855747

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
REL-1017 25 mg	Experimental	During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day in addition to their ongoing antidepressant (ADT)	Drug: REL-1017
Placebo	Placebo Comparator	During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
REL-1017	Drug	REL-1017 tablet	REL-1017 25 mg	Esmethadone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline to Day 28 in MADRS Total Score	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.	Baseline and Day 28

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline to Day 7 in MADRS Total Score	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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Paul Greene, PhD	Relmada Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Relmada Site		Homewood	Alabama	35209	United States
Relmada Site

References Module

Label	URL
Related Info	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 11, 2024	May 18, 2026

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00089 BG00184 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0011 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00024 BG00133 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline to Day 28 in MADRS Total Score

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.

Posted

Least Squares Mean

Standard Error

Scores on a scale (MADRS10)

Baseline and Day 28

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000119 OG001117

Title

Denominators

Categories

Title	Measurements
	OG000-14.81± 1.00 OG001-13.9± 1.01

Secondary

Change From Baseline to Day 7 in MADRS Total Score

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.

Posted

Least Squares Mean

Standard Error

Scores on a scale (MADRS10)

Day 7

ID	Title	Description
OG000	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
OG001	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

Units

Secondary

Change From Baseline to Day 28 in Clinical Global Impression-Severity (CGI-S) Score

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

Posted

Least Squares Mean

Standard Error

Scores on a scale (CGI-S)

Day 28

ID	Title	Description
OG000	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
OG001	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

Units	Counts

Secondary

MADRS10 Remission Rate at 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.

Posted

Count of Participants

Participants

Day 28

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000

Secondary

MADRS10 Response Rate at 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.

The number analyzed was different from the overall partecipants because it indicates the partecipants who actually had the assessment within the pertinent time point window.

Posted

Count of Participants

Participants

Day 28

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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	0	119	0	119	47	119
EG001	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	0	117	0	117	57	117

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Headache	Nervous system disorders	Non-systematic Assessment	EG0005 affected119 at risk EG0019 affected117 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG0003 affected119 at risk EG0014 affected117 at risk
Sonnolence	Nervous system disorders	Non-systematic Assessment	EG0004 affected119 at risk EG0011 affected117 at risk
Tension headache	Nervous system disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0012 affected117 at risk
Brain fog	Nervous system disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Hypersomnia	Nervous system disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Memory impairment	Nervous system disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Migraine	Nervous system disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Paraesthesia	Nervous system disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Tremor	Nervous system disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0003 affected119 at risk EG0015 affected117 at risk
Diarrhoea	Gastrointestinal disorders	Non-systematic Assessment	EG0003 affected119 at risk EG0014 affected117 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0013 affected117 at risk
Dry mouth	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0013 affected117 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG0003 affected119 at risk EG0011 affected117 at risk
Abdominal discomfort	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0012 affected117 at risk
Gastroesophageal	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Abdominal pain upper	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Paraesthesia oral	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
COVID-19	Infections and infestations	Non-systematic Assessment	EG0002 affected119 at risk EG0014 affected117 at risk
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment	EG0004 affected119 at risk EG0011 affected117 at risk
Urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0002 affected119 at risk EG0013 affected117 at risk
Nasopharygitis	Infections and infestations	Non-systematic Assessment	EG0001 affected119 at risk EG0012 affected117 at risk
Gastoenteritis	Infections and infestations	Non-systematic Assessment	EG0002 affected119 at risk EG0010 affected117 at risk
Sinusitis	Infections and infestations	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Gastoenteritis viral	Infections and infestations	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Insomnia	Psychiatric disorders	Non-systematic Assessment	EG0002 affected119 at risk EG0015 affected117 at risk
Abnormal dreams	Psychiatric disorders	Non-systematic Assessment	EG0002 affected119 at risk EG0012 affected117 at risk
Anxiety	Psychiatric disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0012 affected117 at risk
Depression	Psychiatric disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Irritability	Psychiatric disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Binge drinking	Psychiatric disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Allucinathion, auditory	Psychiatric disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Panic attack	Psychiatric disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Suicidal behaviour	Psychiatric disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Suicidal ideation	Psychiatric disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Fatigue	General disorders	Non-systematic Assessment	EG0004 affected119 at risk EG0013 affected117 at risk
Pyrexia	General disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0012 affected117 at risk
Chest discomfort	General disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Malaise	General disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Non-Cardiac Chest pain	General disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Pain	General disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Aspartate aminotransferase increased	Investigations	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Blood pressure increased	Investigations	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Alanine aminotransferase increased	Investigations	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Blood creatine phosphokinase increased	Investigations	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Electrocardiogram T wave amplitude decreased	Investigations	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Heart rate increased	Investigations	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Hepatic enzyme increased	Investigations	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Weight increased	Investigations	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Abnormal uterine bleeding	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Dysmenorrhoea	Reproductive system and breast disorders	Non-systematic Assessment	EG0002 affected119 at risk EG0011 affected117 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Ejaculation delayed	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Erectile dysfunction	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Menstruation irregular	Reproductive system and breast disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Palpitations	Cardiac disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0015 affected117 at risk
Sinus tachycardia	Cardiac disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Arthropod sting	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Contusion	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Foot fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Ligament sprain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Muscle strain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Product use complaint	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Skin laceration	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected119 at risk EG0011 affected117 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Back pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0011 affected117 at risk
Joint stiffness	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0012 affected117 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Anaemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Leukocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Mesenteric lymphadenitis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Neutrophilia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Thrombocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Increased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0012 affected117 at risk
Decreased appetite	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Tinnitus	Ear and labyrinth disorders	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Seasonal allergy	Immune system disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Oversensing	Product Issues	Non-systematic Assessment	EG0000 affected119 at risk EG0011 affected117 at risk
Urinary hesitation	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk
Hot flush	Vascular disorders	Non-systematic Assessment	EG0001 affected119 at risk EG0010 affected117 at risk

Study REL-1017-302 was terminated early by the Sponsor following the prespecified interim analysis for sample size re-estimation at approximately 75% enrollment of the planned sample size (N=280). Safety data were collected.

Certain Agreements

First MCP Posted Date

ID	Term
D003865	Depressive Disorder, Major
D003863	Depression

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders
D001526	Behavioral Symptoms
D001519	Behavior