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This study will evaluate the efficacy, safety, and tolerability of rapastinel 450 milligrams (mg) compared to placebo adjunctive to antidepressant therapy (ADT) in patients with major depressive disorder (MDD) who have a partial response to ADT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapastinel 450 mg | Experimental | 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. |
|
| 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. |
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| 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 Study | 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jenna Hoogerheyde | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harmonex Neuroscience Research | Dothan | Alabama | 36303 | United States | ||
| NoesisPharma |
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| Label | URL |
|---|---|
| More Information | View source |
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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).
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| 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 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2018 | Oct 25, 2019 |
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| 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 |
| Phoenix |
| Arizona |
| 85016 |
| United States |
| Sun Valley Research Center | Imperial | California | 92251 | United States |
| Irvine Center for Clinical Research, Inc | Irvine | California | 92614 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Asclepes Research Centers | Panorama City | California | 91402 | United States |
| Artemis Institute for Clinical Research | San Marcos | California | 92078 | United States |
| MCB Clinical Research Center | Colorado Springs | Colorado | 80910 | United States |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Innova Clinical Trials Inc. | Miami | Florida | 33133 | United States |
| Combined Research Orlando Phase I-IV | Orlando | Florida | 32807 | United States |
| Olympian Clinical Research | Tampa | Florida | 33609 | United States |
| The University of South Florida Board of Trustees, A public Body Corporate, for University of South Florida | Tampa | Florida | 33613 | United States |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | United States |
| AMR - Baber Research, Inc. | Naperville | Illinois | 60563 | United States |
| Psychiatric Associates | Overland Park | Kansas | 66211 | United States |
| Louisiana Clinical Research | Shreveport | Louisiana | 71101 | United States |
| Sheppard Pratt Health System | Baltimore | Maryland | 21204 | United States |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01655 | United States |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | United States |
| St. Charles Psychiatric Associates - Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| Alivation Research | Lincoln | Nebraska | 68526 | United States |
| Healthy Perspectives - Innovative Mental Health Services. PLLC | Nashua | New Hampshire | 03060 | United States |
| Hassman Research Institute, LLC | Berlin | New Jersey | 08009 | United States |
| Global Medical Institute, LLC | Princeton | New Jersey | 08540 | United States |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | United States |
| Albuquerque Neuroscience, Inc | Albuquerque | New Mexico | 87109 | United States |
| SPRI Clinical Trials, Inc | Brooklyn | New York | 11235 | United States |
| Manhattan Behavioral Medicine | New York | New York | 10036 | United States |
| Fieve Clinical Research | New York | New York | 10168 | United States |
| New Hope Clinical Research Inc. | Charlotte | North Carolina | 28211 | United States |
| Dr. Cherian Verghese | Norristown | Pennsylvania | 20006 | United States |
| Research Strategies of Memphis, LLC | Memphis | Tennessee | 38119 | United States |
| Houston Clinical Trials, LLC | Bellaire | Texas | 77401 | United States |
| North Texas Clinical Trials | Fort Worth | Texas | 76104 | United States |
| Grayline Clinical Drug Trials | Wichita Falls | Texas | 76309 | United States |
| Psychiatric and Behavioral Solutions | Salt Lake City | Utah | 84105 | United States |
| Department of Psychiatry and Neurobehavioral Sciences, University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Psychiatric Alliance of the Blue Ridge, Inc. | Charlottesville | Virginia | 22903 | United States |
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. |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| 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 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 |
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| 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 |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| MADRS total score at baseline | 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. | Mean | Standard Deviation | Scores on a Scale |
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| 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 Study | 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 |
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| 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. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline and Day 8 |
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| 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 284. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline and Day 21 |
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| 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 284. | Posted | Least Squares Mean | Standard Error | Score on a Scale | Baseline and Day 8 |
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Adverse Events were collected for up to 28 days.
The Safety Population will consist of all patients who were randomized and received at least 1 dose of IP during the randomized treatment period.
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| 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. | 1 | 209 | 3 | 209 | 18 | 209 |
| EG001 | Rapastinel 450 mg | 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. | 0 | 206 | 0 | 206 | 15 | 206 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 21.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA Version 21.1 | Systematic Assessment |
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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 | Jan 25, 2019 | Oct 25, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C507283 | GLYX-13 peptide |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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