Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 mg compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapastinel 450 mg | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapastinel | Drug | Rapastinel pre-filled syringes for weekly IV injections. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial | 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. | Baseline and 3 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1
Lifetime history of meeting DSM-5 criteria for:
Significant suicide risk, as judged by the Investigator.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jenna Hoogerheyde | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Research LLC. | Beverly Hills | California | 90036 | United States | ||
| ATP Clinical Research Inc. |
Not provided
| Label | URL |
|---|---|
| More Information | View source |
Not provided
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).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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. |
| FG001 | Rapastinel 450 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2018 | Sep 21, 2019 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo-matching rapastinel pre-filled syringes for weekly IV injections. |
|
| Baseline and Day 8 |
| Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population | 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. | Baseline and Day 21 |
| Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population | 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. | Baseline and Day 8 |
| Costa Mesa |
| California |
| 92626 |
| United States |
| Pharmacology Research Institute | Encino | California | 91316 | United States |
| Collaborative Neuroscience Network, LLC | Garden Grove | California | 92845 | United States |
| Synergy San Diego | Lemon Grove | California | 91945 | United States |
| Pharmacology Research Institute | Los Alamitos | California | 90720 | United States |
| Excell Research | Oceanside | California | 92056 | United States |
| Anderson Clinical Research | Redlands | California | 92374 | United States |
| Thomas M. Shiovitz, M.D., Inc., DBA California Neuroscience Research Medical Group, Inc., | Sherman Oaks | California | 91403 | United States |
| Viking Clinical Research | Temecula | California | 92591 | United States |
| Pacific Clinical Research Medical | Upland | California | 91786 | United States |
| Comprehensive Psychiatric Care | Norwich | Connecticut | 06360 | United States |
| Meridien Research | Bradenton | Florida | 34201 | United States |
| MD Clinical | Hallandale | Florida | 33009 | United States |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | United States |
| Meridien Research | Lakeland | Florida | 33805 | United States |
| Institute for Advanced Medical Research | Alpharetta | Georgia | 30005 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Adams Clinical Trials | Watertown | Massachusetts | 02472 | United States |
| Altea Research | Las Vegas | Nevada | 89102 | United States |
| Bioscience Research | Mount Kisco | New York | 10549 | United States |
| Eastside Comprehensive Medical Center, LLC | New York | New York | 10128 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Neuro-Behavioral Clinical Research, Inc | Canton | Ohio | 44718 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45219 | United States |
| Midwest Clinical Research Center LLC | Dayton | Ohio | 45417 | United States |
| IPS Research | Oklahoma City | Oklahoma | 73103 | United States |
| Clinical Neuroscience Solutions, Inc | Memphis | Tennessee | 38119 | United States |
| Donald J. Garcia, Jr., MD, PA | Austin | Texas | 78737 | United States |
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
| NorthWest Clinical Research Center | Bellevue | Washington | 98007 | United States |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 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. |
| BG001 | Rapastinel 450 mg | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| MADRS total score at baseline | Mean | Standard Deviation | Score on a Scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at the End of Trial | 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. | 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. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline and 3 Weeks |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in MADRS Total Score | 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. | 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. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline and Day 8 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 21 in MADRS Total Score for the Placebo Non-responders of mITT Population | 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. | The baseline population for placebo non-responders is 292. One participant was randomized but not treated. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline and Day 21 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Day 8 in MADRS Total Score for the Placebo Non-responders of mITT Population | 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. | The baseline population for placebo non-responders is 292. One participant was randomized but not treated. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline and Day 8 |
|
Adverse Events were collected for 3 weeks.
The Safety Population will consist of all patients who were randomized and received at least 1 dose of IP during the randomized treatment period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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. | 0 | 226 | 1 | 226 | 12 | 226 |
| EG001 | Rapastinel 450 mg | 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. | 0 | 231 | 1 | 231 | 27 | 231 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dysgeusia | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | IR-CTRegistration@allergan.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 10, 2018 | Sep 21, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Multiple |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|