Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
Purpose
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
Conditions
- Major Depressive Disorder
- Depression
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Body mass index (BMI) between 18.0 and 35.0 kg/m2. - Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD. - Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.
Exclusion Criteria
- Psychiatric hospitalization during the current major depressive episode. - History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant. - Participants who, in the Investigator's judgment, are at significant risk for suicide. - Pregnant or planning to become pregnant.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental REL-1017 25 mg |
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) |
|
|
Placebo Comparator Placebo |
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) |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Relmada Therapeutics, Inc.
Detailed Description
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 in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.
