Conditions: Major Depressive Disorder
Keywords: REL-1017
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 232
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 a monotherapy for Major Depressive Disorder.

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. 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.

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: 
Protocol Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-
Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy 
for Major Depressive Disorder 
(The RELIANCE-III Study) 
Protocol Number: REL-1017-303 
NCT Number 
NCT05081167 
Name of Investigational Product: 
REL-1017 
Phase of Development: 
3 
Indication: 
Major Depressive Disorder 
Sponsor: 
Relmada Therapeutics Inc. 
Protocol Date: 
August 03 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 Monotherapy for 
Major Depressive Disorder (The RELIANCE-III Study) 
Protocol Number: 
REL-1017-303 
Confidentiality and Current Good Clinical Practice (GCP)/E6(R2): 
I agree, as an Investigator conducting this study: 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


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