CLINICAL TRIALS PROFILE FOR REL-1017

Clinical Trials for REL-1017

Trial ID	Title	Status	Sponsor	Phase	Summary
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	Completed	INC Research	Phase 2	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.
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	Completed	Syneos Health	Phase 2	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.
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	Completed	Relmada Therapeutics, Inc.	Phase 2	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.

Clinical Trial Conditions for REL-1017

Condition Name

Condition Name for
Intervention	Trials
Major Depressive Disorder	4
Neuropathic Pain	2
Depressive Disorder, Major	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Depressive Disorder, Major	5
Depressive Disorder	5
Depression	5

Clinical Trial Locations for REL-1017

Trials by Country

Trials by Country for
Location	Trials
United States	55
Italy	1
Switzerland	1

Trials by US State

Trials by US State for
Location	Trials
Texas	4
Florida	4
California	4
Arkansas	4
Massachusetts	3

Clinical Trial Progress for REL-1017

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	4
Phase 2	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Recruiting	4
Completed	3
Not yet recruiting	1

Clinical Trial Sponsors for REL-1017

Sponsor Name

Sponsor Name for
Sponsor	Trials
Relmada Therapeutics, Inc.	7
INC Research	1
Syneos Health	1

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	7
Other	4