A Study of Rapastinel for Rapid Treatment of Depression and Suicidality in Major Depressive Disorder
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|ClinicalTrials.gov Identifier: NCT03352453|
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depressive Disorder, Major||Drug: Rapastinel Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Multicenter, Efficacy and Safety Study of Rapastinel for Rapid Treatment of Symptoms of Depression and Suicidality in Adult Patients With Major Depressive Disorder|
|Actual Study Start Date :||December 5, 2017|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: Rapastinel 450mg
Rapastinel 450 milligram (mg) weekly intravenous (IV) injections.
Rapastinel pre-filled syringes for weekly IV injections.
Placebo Comparator: Placebo
Placebo-matching rapastinel weekly IV injections.
Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
- Change from baseline in Montgomery-Asberg Depression Rating Scale) MADRS Total Score [ Time Frame: Baseline and 1 Day ]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.
- Change from Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score [ Time Frame: Baseline and 1 Day ]The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. The scale is compatible with the FDA categories for prospective assessment of suicidal ideation and behavior. Developed for use as both a safety and efficacy outcome measure in research and in clinical settings, the scale is sensitive enough to detect an efficacy signal in conventional sample sizes used in clinical trials.
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): NCT03352453
|Contact: Clinical Trials Registry Team||1-877-277-8566||IR-CTRegistration@Allergan.com|
Show 28 Study Locations
|Study Director:||Robert Hayes, PhD||Allergan|