Trial Outcomes & Findings for Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD) (NCT NCT03668600)
NCT ID: NCT03668600
Last Updated: 2020-07-17
Results Overview
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
230 participants
Primary outcome timeframe
Up to 45 Weeks
Results posted on
2020-07-17
Participant Flow
Patients from RAP-MD-99, completed 1 of the rapastinel lead-in studies - RAP-MD-04, RAP-MD-05, RAP-MD-06 or RAP-MD-33.
Participant milestones
| Measure |
Rapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
|
|---|---|
|
Overall Study
STARTED
|
230
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
230
|
Reasons for withdrawal
| Measure |
Rapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
|
|---|---|
|
Overall Study
Study Terminated by the Sponsor
|
157
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Withdrawal by Subject
|
56
|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
Baseline characteristics by cohort
| Measure |
Rapastinel
n=230 Participants
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
|
|---|---|
|
Age, Continuous
|
48.3 Years
STANDARD_DEVIATION 11.49 • n=99 Participants
|
|
Sex: Female, Male
Female
|
191 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
209 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
200 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Weight
|
84.70 kg
STANDARD_DEVIATION 18.55 • n=99 Participants
|
|
Height
|
166.22 cm
STANDARD_DEVIATION 8.82 • n=99 Participants
|
|
BMI
|
30.63 kg/m^2
STANDARD_DEVIATION 6.66 • n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 45 WeeksPopulation: The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
A Treatment Emergent Adverse Event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Adverse Drug Reaction was a harmful and unintended reaction that is incurred during routine administration or use of the drug, whose causal relationship with the drug cannot be excluded.
Outcome measures
| Measure |
Rapastinel
n=230 Participants
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
|
|---|---|
|
Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
|
100 Participants
|
Adverse Events
Rapastinel
Serious events: 4 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rapastinel
n=230 participants at risk
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
|
|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
0.43%
1/230 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
|
Product Issues
Device malfunction
|
0.43%
1/230 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
|
Cardiac disorders
Pericardial effusion
|
0.43%
1/230 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
|
Infections and infestations
Pneumonia
|
0.43%
1/230 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.52%
1/191 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.43%
1/230 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.43%
1/230 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.43%
1/230 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
Other adverse events
| Measure |
Rapastinel
n=230 participants at risk
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
|
|---|---|
|
Nervous system disorders
Dysgeusia
|
6.1%
14/230 • Up to 45 Weeks
The Open-label Safety Population will consist of all participants who signed the RAP-MD-99 ICF and who received at least 1 dose of open-label rapastinel during the OLTP of the protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER