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

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ClinicalTrials.gov Identifier: NCT02951988
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : September 6, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Drug: Rapastinel Drug: Placebo-matching Rapastinel Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Rapastinel as Adjunctive Therapy in the Prevention of Relapse in Patients With Major Depressive Disorder
Actual Study Start Date : November 13, 2016
Estimated Primary Completion Date : September 27, 2019
Estimated Study Completion Date : September 27, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Rapastinel
Rapastinel pre-filled syringes for IV injections.

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.
Drug: Rapastinel
Rapastinel pre-filled syringes for IV injections.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951988


  Show 137 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Robert Hayes, PhD Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02951988     History of Changes
Other Study ID Numbers: RAP-MD-04
First Posted: November 1, 2016    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms