A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)

Phase 3

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: Placebo; Drug: Rapastinel

• Registration Number: NCT02943577
• Lead Sponsor: Naurex, Inc, an affiliate of Allergan plc

Brief Summary

This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (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

Study Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2016-11-02
• Primary Completion: 2018-10-26
• Study Completion: 2018-11-21
• Status Verified: 2019-10
• Results First Submitted: 2019-10-25
• Results First Submitted QC: 2019-10-25
• Last Update Submitted: 2019-10-25
• Results First Posted: 2019-11-13
• Last Update Posted: 2019-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 429

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 stress 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 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 Study	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 (40)

Harmonex Neuroscience Research; 🇺🇸 Dothan, Alabama, United States

NoesisPharma; 🇺🇸 Phoenix, Arizona, United States

Sun Valley Research Center; 🇺🇸 Imperial, California, United States

Irvine Center for Clinical Research, Inc; 🇺🇸 Irvine, California, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

Asclepes Research Centers; 🇺🇸 Panorama City, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Marcos, California, United States

MCB Clinical Research Center; 🇺🇸 Colorado Springs, Colorado, United States

Gulfcoast Clinical Research Center; 🇺🇸 Fort Myers, Florida, United States

Research Centers of America; 🇺🇸 Hollywood, Florida, United States

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