ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02951988
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

October 31, 2016
November 1, 2016
October 18, 2018
November 13, 2016
September 27, 2019   (Final data collection date for primary outcome measure)
Time to First Relapse during the First 52 Weeks of the Double-Blind Treatment Period [ Time Frame: 52 Weeks ]
Time in days from randomization to relapse. The primary efficacy analysis will compare the time to relapse between placebo and rapastinel treatment groups using the log-rank test.
Same as current
Complete list of historical versions of study NCT02951988 on ClinicalTrials.gov Archive Site
Time to First Relapse during the Entire Double-Blind Treatment Period [ Time Frame: 104 Weeks ]
Time in days from randomization to relapse. The secondary efficacy analysis will compare the time to relapse between placebo and rapastinel treatment groups using the log-rank test.
Same as current
Not Provided
Not Provided
 
A Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
This study will evaluate the efficacy, safety and tolerability of rapastinel 450 milligrams (mg) intravenous (IV) once weekly or once every 2 weeks versus placebo as an adjunctive treatment to ongoing anti-depressive therapy (ADT) in the prevention of relapse in participants with Major Depressive Disorder (MDD).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Depressive Disorder, Major
  • Drug: Rapastinel
    Rapastinel pre-filled syringes for IV injections.
  • Drug: Placebo-matching Rapastinel
    Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
  • Experimental: Rapastinel 450 mg Weekly
    Rapastinel 450 milligrams (mg) intravenous (IV) open label once a week followed by rapastinel 450 mg IV once a week. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
    Intervention: Drug: Rapastinel
  • Experimental: Rapastinel 450 mg Every 2 Weeks
    Rapastinel 450 mg IV open label once a week followed by rapastinel 450 mg IV once every 2 weeks. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
    Intervention: Drug: Rapastinel
  • Placebo Comparator: Placebo
    Rapastinel 450 mg IV open label once a week followed by placebo-matching rapastinel 450 mg IV once a week. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
    Intervention: Drug: Placebo-matching Rapastinel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
604
1500
September 27, 2019
September 27, 2019   (Final data collection date for primary outcome measure)

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 Screening
  • 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 Screening
  • 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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02951988
RAP-MD-04
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Naurex, Inc, an affiliate of Allergan plc
Naurex, Inc, an affiliate of Allergan plc
Not Provided
Study Director: Robert Hayes, PhD Allergan
Naurex, Inc, an affiliate of Allergan plc
October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP