A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)

Phase 3

Completed

Conditions: Depressive Disorder, Major

Interventions: Drug: Placebo
Drug: Rapastinel

Registration Number: NCT02932943

Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

Brief Summary: This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 465

Inclusion Criteria

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Lifetime history of meeting DSM-5 criteria for:
1. Schizophrenia spectrum or other psychotic disorder
2. Bipolar or related disorder
3. Major neurocognitive disorder
4. Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
5. Dissociative disorder
6. Posttraumatic stess disorder
7. MDD with psychotic features
Significant suicide risk, as judged by the Investigator.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo-matching rapastinel weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Rapastinel 450 mg	Rapastinel	Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial	Baseline and 3 Weeks	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in MADRS Total Score	Baseline and Day 8	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population	Baseline and Day 8	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.
Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population	Baseline and Day 21	The MADRS is a clinician-rated scale to assess depressive symptomatology during the preceding week. Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score ranges from 0 to 60 with a higher score indicating more depression. A negative change score indicates improvement.

Trial Locations

Locations (28): Southern California Research LLC.
🇺🇸
Beverly Hills, California, United States
ATP Clinical Research Inc.
🇺🇸
Costa Mesa, California, United States
Pharmacology Research Institute
🇺🇸
Los Alamitos, California, United States
Collaborative Neuroscience Network, LLC
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Garden Grove, California, United States
Synergy San Diego
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Lemon Grove, California, United States
Excell Research
🇺🇸
Oceanside, California, United States
Anderson Clinical Research
🇺🇸
Redlands, California, United States
Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc.,
🇺🇸
Sherman Oaks, California, United States
Viking Clinical Research
🇺🇸
Temecula, California, United States
Pacific Clinical Research Medical
🇺🇸
Upland, California, United States
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Southern California Research LLC.
🇺🇸Beverly Hills, California, United States