Depressive Disorder, Major
Conditions
Keywords
Depression
Brief summary
Multicenter, open-label, long-term extended access treatment protocol in adult patients with a primary diagnosis of MDD.
Interventions
DRUGRapastinel
Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Sponsors
Naurex, Inc, an affiliate of Allergan plc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Completion of lead-in study * Adequate therapeutic benefit in the lead-in study to justify continuation of treatment with rapastinel in the judgement of the investigator
Exclusion criteria
* Suicide risk, as determined by meeting any of the following criteria: 1. A suicide attempt within the past year 2. Significant risk, as judged by the investigator, based on the psychiatric interview or information collected in the Columbia- Suicide Severity Rating Scale (C-SSRS) at any visit in the lead-in study 3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit during participation in the lead-in study where MADRS was conducted. * At imminent risk of injuring self or others or causing significant damage to property, as judged by the investigator * Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during participation * Females of childbearing potential and male partners of females of childbearing potential, not using a reliable means of contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | Up to 45 Weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Rapastinel Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration) | 230 |
| Total | 230 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lack of Efficacy | 7 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Pregnancy | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Study Terminated by the Sponsor | 157 |
| Overall Study | Withdrawal by Subject | 56 |
Baseline characteristics
| Characteristic | Rapastinel |
|---|---|
| Age, Continuous | 48.3 Years STANDARD_DEVIATION 11.49 |
| BMI | 30.63 kg/m^2 STANDARD_DEVIATION 6.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 209 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 166.22 cm STANDARD_DEVIATION 8.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 200 Participants |
| Sex: Female, Male Female | 191 Participants |
| Sex: Female, Male Male | 39 Participants |
| Weight | 84.70 kg STANDARD_DEVIATION 18.55 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 230 |
| other Total, other adverse events | 14 / 230 |
| serious Total, serious adverse events | 4 / 230 |
Outcome results
Primary
Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs)
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.
Time frame: Up to 45 Weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rapastinel | Count of Participants Experiencing One or More Treatment Emergent Adverse Events (TEAEs) | 100 Participants |