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

Depressive Disorder, Major Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932943
• Other study ID #: RAP-MD-01
• Status: Completed
• Phase: Phase 3
• Start date: October 15, 2016
• Est. completion date: November 8, 2018

Study information

• Verified date: September 2019
• Source: Naurex, Inc, an affiliate of Allergan plc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 465
• Est. completion date: November 8, 2018
• Est. primary completion date: September 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-human chorionic gonadotropin (ß-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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease

Intervention

Drug:
• Rapastinel
Rapastinel pre-filled syringes for weekly IV injections.
• Placebo
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

Locations

Country	Name	City	State
United States	Institute for Advanced Medical Research	Alpharetta	Georgia
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Donald J. Garcia, Jr., MD, PA	Austin	Texas
United States	NorthWest Clinical Research Center	Bellevue	Washington
United States	Southern California Research LLC.	Beverly Hills	California
United States	Meridien Research	Bradenton	Florida
United States	Neuro-Behavioral Clinical Research, Inc	Canton	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	ATP Clinical Research Inc.	Costa Mesa	California
United States	Midwest Clinical Research Center LLC	Dayton	Ohio
United States	Pharmacology Research Institute	Encino	California
United States	Collaborative Neuroscience Network, LLC	Garden Grove	California
United States	MD Clinical	Hallandale Beach	Florida
United States	Clinical Neuroscience Solutions, Inc	Jacksonville	Florida
United States	Meridien Research	Lakeland	Florida
United States	Altea Research	Las Vegas	Nevada
United States	Synergy San Diego	Lemon Grove	California
United States	Pharmacology Research Institute	Los Alamitos	California
United States	Clinical Neuroscience Solutions, Inc	Memphis	Tennessee
United States	Bioscience Research	Mount Kisco	New York
United States	Eastside Comprehensive Medical Center, LLC	New York	New York
United States	Comprehensive Psychiatric Care	Norwich	Connecticut
United States	Excell Research	Oceanside	California
United States	IPS Research	Oklahoma City	Oklahoma
United States	Anderson Clinical Research	Redlands	California
United States	Finger Lakes Clinical Research	Rochester	New York
United States	Clinical Trials of Texas	San Antonio	Texas
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	Adams Clinical Trials	Watertown	Massachusetts

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial	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.	Baseline and 3 Weeks
Secondary	Change From Baseline in MADRS Total Score	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.	Baseline and Day 8
Secondary	Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population	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.	Baseline and Day 21
Secondary	Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population	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.	Baseline and Day 8

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