A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-02)

NCT02943564 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: RAP-MD-02
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 66

Brief Summary

This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 mg, compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Study

  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 Outcomes (1)

• Change From Baseline in MADRS Total Score

  Baseline and Day 8

Study Arms (3)

Rapastinel 225 mg

EXPERIMENTAL

Rapastinel 225 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.

Drug: Rapastinel

Rapastinel 450 mg

EXPERIMENTAL

Rapastinel 450 mg 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.

Drug: Rapastinel

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Rapastinel DRUG

Rapastinel pre-filled syringes for weekly IV injections.

Rapastinel 225 mg; Rapastinel 450 mg

Placebo DRUG

Placebo-matching rapastinel pre-filled syringes for weekly IV injections.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Schizophrenia spectrum or other psychotic disorder
• Bipolar or related disorder
• Major neurocognitive disorder
• 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
• Dissociative disorder
• Posttraumatic stress disorder
• MDD with psychotic features
• Significant suicide risk, as judged by the Investigator.

Sponsors & Collaborators

• Naurex, Inc, an affiliate of Allergan plc: lead

Study Sites (66)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of Arizona Department of Psychiatry

Tucson, Arizona, 85724, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

California Pharmaceutical Research Institute, Inc

Anaheim, California, 92804, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Behavioral Research Specialists, LLC

Glendale, California, 91206, United States

Location

Synergy Clinical Research Center of Escondido

Lemon Grove, California, 91945, United States

Location

Pacific Research Partners; LLC.

Oakland, California, 94607, United States

Location

CITrials

Riverside, California, 92506, United States

Location

Artemis Institute for Clinical Research

San Diego, California, 92103, United States

Location

PCSD Feighner Research

San Diego, California, 92108, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Reliable Clinical Research

Hialeah, Florida, 33012, United States

Location

Advanced Research Institute of Miami

Homestead, Florida, 33030, United States

Location

Innovative Clinical Research, Inc

Lauderhill, Florida, 33319, United States

Location

International Research Associates, LLC

Miami, Florida, 33183, United States

Location

Sarkis Clinical Trials

Ocala, Florida, 34474, United States

Location

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

Location

Clinical Neuroscience Solutions, Inc

Orlando, Florida, 32801, United States

Location

Millenia Psychiatry & Research, Inc

Orlando, Florida, 32839, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

IRIS Research

Smyrna, Georgia, 30080, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

Phoenix Medical Research

Prairie Village, Kansas, 66208, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

J Gary Booker, MD APMC

Shreveport, Louisiana, 71104, United States

Location

Pharmasite Research, Inc

Baltimore, Maryland, 21208, United States

Location

CBH Health

Rockville, Maryland, 20850, United States

Location

Boston Clinical Trials

Boston, Massachusetts, 02131, United States

Location

ActivMed Practices & Research, Inc.

Methuen, Massachusetts, 01844, United States

Location

BTC of New Bedford

New Bedford, Massachusetts, 02740, United States

Location

Coastal Research Associates

Weymouth, Massachusetts, 02190, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Millennium Psychiatric Associates

Olivette, Missouri, 63132, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Pharmaceutical Research Associates Inc

Marlton, New Jersey, 08053, United States

Location

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10312, United States

Location

Richard H. Weisler, MD, PA

Raleigh, North Carolina, 27609, United States

Location

Patient Priority Clinical Site, LLC

Cincinnati, Ohio, 45215, United States

Location

The Ohio State University Department of Psychiatry

Columbus, Ohio, 43210, United States

Location

Charak Clinical Research Center

Garfield Heights, Ohio, 44125, United States

Location

Lindner Center of Hope

Mason, Ohio, 45040, United States

Location

Professional Psychiatric Services

Mason, Ohio, 45040, United States

Location

Red River Medical Research Center, LLC

Oklahoma City, Oklahoma, 73112, United States

Location

Sooner Clinical Research, Inc

Oklahoma City, Oklahoma, 73112, United States

Location

Paradigm Research Professionals

Oklahoma City, Oklahoma, 73118, United States

Location

Summit Research Network

Portland, Oregon, 97210, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Suburban Research Associates

Media, Pennsylvania, 19063, United States

Location

Carolina Clinical Trials, Inc.

Charleston, South Carolina, 29407, United States

Location

Coastal Carolina Research Center, Inc.

Mt. Pleasant, South Carolina, 29464, United States

Location

Community Clinical Research, Inc.

Austin, Texas, 78754, United States

Location

BioBehavioral Research of Austin

Austin, Texas, 78759, United States

Location

Relaro Medical Trials

Dallas, Texas, 75243, United States

Location

El Campo Clinical Trials

El Campo, Texas, 77347, United States

Location

Earle Research

Houston, Texas, 77058, United States

Location

Red Oak Psychiatry Associates, PA

Houston, Texas, 77090, United States

Location

Family Psychiatry of The Wood

The Woodlands, Texas, 77381, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84106, United States

Location

Pacific Institute of Medical Sciences

Bothell, Washington, 98011, United States

Location

Eastside Therapeutic Resource

Everett, Washington, 98201, United States

Location

Related Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

GLYX-13 peptide

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Therapeutic Area, Head
• Organization: Allergan

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Jenna Hoogerheyde

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: November 1, 2016
• Primary Completion: December 12, 2018
• Study Completion: December 18, 2018
• Last Updated: December 27, 2019
• Results First Posted: December 27, 2019

Record last verified: 2019-12

Locations

US (66)