Conditions: Major Depressive Disorder
Keywords: REL-1017
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 227
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: REL-1017 intervention 2: Placebo
Intervention descriptions: intervention 1: REL-1017 tablet intervention 2: Placebo tablet

Protocol document:
Prot_SAP_000.pdf: 
CLINICAL STUDY PROTOCOL 
Protocol Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study to Assess the Efficacy and Safety of REL-1017 for Treatment 
of Major Depressive Disorder 
(The RELIANCE-I Study) 
Protocol Number: REL-1017-301 
NCT Number: 
NCT04688164 
Name of Investigational Product: 
REL-1017 
Phase of Development: 
3 
Indication: 
Major Depressive Disorder 
Sponsor: 
Relmada Therapeutics Inc. 
Document Date: 
December 01 2022 
Certain information within this protocol has been redacted to protect either personally 
identifiable information or company confidential information. 
This may include, but is not limited to, redaction of the following: 
•
Names, addresses, and other personally identifiable information
•
Proprietary information, such as scales or coding systems, which are considered 
confidential information.
•
Other information as needed to protect the trade secret and/or confidential information of 
Relmada Therapeutics






INVESTIGATOR SIGNATURE PAGE 
Protocol Title: 
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled 
Study to Assess the Efficacy and Safety of REL-1017 for Treatment of 
Major Depressive Disorder (The RELIANCE-I Study) 
Protocol Number: 
REL-1017-301 
Confidentiality and Current Good Clinical Practice (GCP)/E6(R2): 
I agree, as an Investigator conducting this study: 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
 
 
 
 
 
 
 
 
 
<Name> 
<Title> 
Investigator Signature 
Date (DD-Mmm-YYYY) 
Institution