A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder

NCT03352453 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: RAP-MD-20
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 17

Brief Summary

The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 a 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 1 Day

• Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score

  The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency.

  Baseline and 1 Day

Secondary Outcomes (2)

• Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

  Baseline and 28 Days

• Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score

  Baseline and 28 Days

Study Arms (2)

Rapastinel 450mg

EXPERIMENTAL

Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.

Drug: Rapastinel

Placebo

PLACEBO COMPARATOR

Placebo-matching rapastinel weekly IV injections.

Drug: Placebo

Interventions

Rapastinel DRUG

Rapastinel pre-filled syringes for weekly IV injections.

Rapastinel 450mg

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 4 weeks and not exceeding 24 months in duration at visit 1
• Have current, ongoing suicidality (ideation or behavior) of sufficient severity to warrant hospitalization based on the judgment of the investigator
• 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 1 month before Visit 1.
• Lifetime history or currently meet 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 homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
• Prior participation in any investigational study of rapastinel/GLYX-13

Sponsors & Collaborators

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

Study Sites (17)

The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham

Birmingham, Alabama, 35294-0107, United States

Location

Collaborative NeuroScience Network, LLC

Garden Grove, California, 92845, United States

Location

Behavioral Research Specialists, LLC

Glendale, California, 91206-4282, United States

Location

Asclepes Research Centers

Panorama City, California, 91402, United States

Location

Institute of Living

Hartford, Connecticut, 06106, United States

Location

Innovative Clinical Research, Inc

Hialeah, Florida, 33012, United States

Location

Research Centers of America, LLC

Oakland Park, Florida, 33334, United States

Location

Atlanta Center for Medical Research (ACMR)

Atlanta, Georgia, 30331, United States

Location

Alexian Brothers Center for Psychiatric Research

Hoffman Estates, Illinois, 60169, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

Altea Research Institute

Las Vegas, Nevada, 89102, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cincinnati VA Medical Center

Cincinnati, Ohio, 45220-2288, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

Carilion Medical Center, a Virginia Nonprofit Corporation

Roanoke, Virginia, 24014-2419, United States

Location

Department of Veterans Affairs Salem VA Medical Center

Salem, Virginia, 24153, United States

Location

Related Links

• Additional information on study locations near you may be found at 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

Limitations and Caveats

Due to study termination, the target number of participants needed to achieve target power and statistically reliable results was not met.

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 2
• 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: November 21, 2017
• First Posted: November 24, 2017
• Study Start: December 15, 2017
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: August 14, 2020
• Results First Posted: August 14, 2020

Record last verified: 2020-07

Locations

US (17)