A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-03)
|
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: NCT02943577 |
|
Recruitment Status :
Completed
First Posted : October 24, 2016
Results First Posted : November 13, 2019
Last Update Posted : November 13, 2019
|
Sponsor:
Naurex, Inc, an affiliate of Allergan plc
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Condition |
Depressive Disorder, Major |
| Interventions |
Drug: Rapastinel Drug: Placebo |
| Enrollment | 429 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details | Prior to randomization, patients entered a 1-wk, double-blind, placebo lead-in period to identify placebo responders. Upon completion of the placebo lead-in period, patients were randomized in 1:1 ratio to receive either rapastinel or placebo. Randomization was stratified by patient's responder status (placebo non-responder vs. placebo responder). |
| Arm/Group Title | Placebo | Rapastinel 450 mg |
|---|---|---|
 Arm/Group Description |
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. | Rapastinel 450 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. |
| Period Title: Overall Study | ||
| Started | 209 | 206 |
| Completed | 204 | 201 |
| Not Completed | 5 | 5 |
| Reason Not Completed | ||
| Protocol Violation | 0 | 1 |
| Adverse Event | 3 | 2 |
| Lost to Follow-up | 0 | 1 |
| Withdrawal by Subject | 1 | 1 |
| Pregnancy | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo | Rapastinel 450 mg | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
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. | Rapastinel 450 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. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 209 | 206 | 415 | |
|
Baseline Analysis Population Description |
The modified Intent-to-Treat (mITT) Population will consist of all patients who were randomized, received at least 1 dose of IP during the randomized treatment period, and had at least 1 post-randomization assessment of the MADRS total score.
|
|||
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 209 participants | 206 participants | 415 participants | |
| 46.4 (11.93) | 47.4 (11.34) | 46.9 (11.64) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 209 participants | 206 participants | 415 participants | |
| Female |
151 72.2%
|
156 75.7%
|
307 74.0%
|
|
| Male |
58 27.8%
|
50 24.3%
|
108 26.0%
|
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 209 participants | 206 participants | 415 participants | |
| Hispanic or Latino |
25 12.0%
|
34 16.5%
|
59 14.2%
|
|
| Not Hispanic or Latino |
184 88.0%
|
172 83.5%
|
356 85.8%
|
|
| Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
|
Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 209 participants | 206 participants | 415 participants | |
| White |
156 74.6%
|
157 76.2%
|
313 75.4%
|
|
| Black or African American |
48 23.0%
|
45 21.8%
|
93 22.4%
|
|
| Asian |
3 1.4%
|
3 1.5%
|
6 1.4%
|
|
| American Indian or Alaska Native |
2 1.0%
|
0 0.0%
|
2 0.5%
|
|
| Native Hawaiian or Other Pacific Islander |
0 0.0%
|
1 0.5%
|
1 0.2%
|
|
|
MADRS total score at baseline
[1] Mean (Standard Deviation) Unit of measure: Scores on a Scale |
||||
| Number Analyzed | 209 participants | 206 participants | 415 participants | |
| 33.8 (4.83) | 34.1 (4.73) | 34.0 (4.76) | ||
|
[1]
Measure Description: 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.
|
||||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title: | Therapeutic Area, Head |
| Organization: | Allergan |
| Phone: | 714-246-4500 |
| EMail: | IR-CTRegistration@allergan.com |
| Responsible Party: | Naurex, Inc, an affiliate of Allergan plc |
| ClinicalTrials.gov Identifier: | NCT02943577 |
| Other Study ID Numbers: |
RAP-MD-03 |
| First Submitted: | October 21, 2016 |
| First Posted: | October 24, 2016 |
| Results First Submitted: | October 25, 2019 |
| Results First Posted: | November 13, 2019 |
| Last Update Posted: | November 13, 2019 |