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Trial record 15 of 890 for:    "Depressive Disorder" [DISEASE] AND MADRS

A Study of Rapastinel as Adjunctive Therapy in Major Depressive Disorder (RAP-MD-01)

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ClinicalTrials.gov Identifier: NCT02932943
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : October 11, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Naurex, Inc, an affiliate of Allergan plc

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 465
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
Hide 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 milligram (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 227 231
Completed 222 224
Not Completed 5 7
Reason Not Completed
Lost to Follow-up             0             2
Adverse Event             2             2
Withdrawal by Subject             3             3
Arm/Group Title Placebo Rapastinel 450 mg Total
Hide 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 milligram (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 226 231 457
Hide 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 226 participants 231 participants 457 participants
45.7  (12.26) 44.9  (12.62) 45.3  (12.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 231 participants 457 participants
Female
172
  76.1%
161
  69.7%
333
  72.9%
Male
54
  23.9%
70
  30.3%
124
  27.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 226 participants 231 participants 457 participants
Hispanic or Latino
29
  12.8%
41
  17.7%
70
  15.3%
Not Hispanic or Latino
197
  87.2%
190
  82.3%
387
  84.7%
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 226 participants 231 participants 457 participants
White
178
  78.8%
183
  79.2%
361
  79.0%
Black or African American
37
  16.4%
32
  13.9%
69
  15.1%
Asian
6
   2.7%
10
   4.3%
16
   3.5%
American Indian or Alaska Native
1
   0.4%
0
   0.0%
1
   0.2%
Native Hawaiian or Other Pacific Islander
2
   0.9%
1
   0.4%
3
   0.7%
Multiple
2
   0.9%
5
   2.2%
7
   1.5%
MADRS total score at baseline  
Mean (Standard Deviation)
Unit of measure:  Score on a Scale
Number Analyzed 226 participants 231 participants 457 participants
35.4  (5.72) 35.6  (4.88) 35.5  (5.31)
1.Primary Outcome
Title Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial
Hide 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.
Time Frame Baseline and 3 Weeks
Hide Outcome Measure Data
Hide 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.
Arm/Group Title Placebo Rapastinel 450 mg
Hide 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 milligram (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.
Overall Number of Participants Analyzed 226 231
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-5  (0.54) -4.7  (0.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rapastinel 450 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6482
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.3
Confidence Interval (2-Sided) 95%
-1.07 to 1.72
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in MADRS Total Score
Hide 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.
Time Frame Baseline and Day 8
Hide Outcome Measure Data
Hide 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.
Arm/Group Title Placebo Rapastinel 450 mg
Hide 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 milligram (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.
Overall Number of Participants Analyzed 226 231
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-5.1  (0.49) -5.5  (0.48)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rapastinel 450 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5590
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-1.61 to 0.87
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population
Hide 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.
Time Frame Baseline and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
The baseline population for placebo non-responders is 292. One participant was randomized but not treated.
Arm/Group Title Placebo Rapastinel 450 mg
Hide 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 milligram (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.
Overall Number of Participants Analyzed 147 144
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-4.6  (0.65) -4.4  (0.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rapastinel 450 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8131
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.2
Confidence Interval (2-Sided) 95%
-1.53 to 1.95
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population
Hide 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.
Time Frame Baseline and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The baseline population for placebo non-responders is 292. One participant was randomized but not treated.
Arm/Group Title Placebo Rapastinel 450 mg
Hide 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 milligram (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.
Overall Number of Participants Analyzed 147 144
Least Squares Mean (Standard Error)
Unit of Measure: Score on a Scale
-4.1  (0.61) -4.5  (0.61)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Rapastinel 450 mg
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6108
Comments [Not Specified]
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value -0.4
Confidence Interval (2-Sided) 95%
-2.05 to 1.21
Estimation Comments [Not Specified]
Time Frame Adverse Events were collected for 3 weeks.
Adverse Event Reporting Description The Safety Population will consist of all patients who were randomized and received at least 1 dose of IP during the randomized treatment period.
 
Arm/Group Title Placebo Rapastinel 450 mg
Hide 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 milligram (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.
All-Cause Mortality
Placebo Rapastinel 450 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/226 (0.00%)   0/231 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Rapastinel 450 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/226 (0.44%)   1/231 (0.43%) 
Infections and infestations     
Diverticulitis  1  0/226 (0.00%)  1/231 (0.43%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/226 (0.44%)  0/231 (0.00%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Rapastinel 450 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   12/226 (5.31%)   27/231 (11.69%) 
Nervous system disorders     
Dysgeusia  1  0/226 (0.00%)  12/231 (5.19%) 
Headache  1  12/226 (5.31%)  16/231 (6.93%) 
1
Term from vocabulary, MedDRA 21.1
Indicates events were collected by systematic assessment
Certain Agreements
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
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: IR-CTRegistration@allergan.com
Layout table for additonal information
Responsible Party: Naurex, Inc, an affiliate of Allergan plc
ClinicalTrials.gov Identifier: NCT02932943     History of Changes
Other Study ID Numbers: RAP-MD-01
First Submitted: October 12, 2016
First Posted: October 13, 2016
Results First Submitted: September 21, 2019
Results First Posted: October 11, 2019
Last Update Posted: October 11, 2019