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This study will evaluate the efficacy, safety, and tolerability of two doses of rapastinel, 225 milligrams (mg) and 450 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 225 mg | Experimental | Rapastinel 225 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. |
|
| Rapastinel 450 mg | Experimental | Rapastinel 450 mg 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. |
|
| 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 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 |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| University of Arizona Department of Psychiatry |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | 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).
658 total enrolled. 20 discontinued prior to randomization.
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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 225 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 | Dec 10, 2018 | Dec 11, 2019 |
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| Placebo | Drug | Placebo-matching rapastinel pre-filled syringes for weekly IV injections. |
|
| Baseline and Day 8 |
| Tucson |
| Arizona |
| 85724 |
| United States |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | United States |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | United States |
| California Pharmaceutical Research Institute, Inc | Anaheim | California | 92804 | United States |
| ProScience Research Group | Culver City | California | 90230 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | United States |
| Synergy Clinical Research Center of Escondido | Lemon Grove | California | 91945 | United States |
| Pacific Research Partners; LLC. | Oakland | California | 94607 | United States |
| CITrials | Riverside | California | 92506 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| PCSD Feighner Research | San Diego | California | 92108 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Reliable Clinical Research | Hialeah | Florida | 33012 | United States |
| Advanced Research Institute of Miami | Homestead | Florida | 33030 | United States |
| Innovative Clinical Research, Inc | Lauderhill | Florida | 33319 | United States |
| International Research Associates, LLC | Miami | Florida | 33183 | United States |
| Sarkis Clinical Trials | Ocala | Florida | 34474 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | United States |
| Millenia Psychiatry & Research, Inc | Orlando | Florida | 32839 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| IRIS Research | Smyrna | Georgia | 30080 | United States |
| Great Lakes Clinical Trials | Chicago | Illinois | 60640 | United States |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Phoenix Medical Research | Prairie Village | Kansas | 66208 | United States |
| Heartland Research Associates | Wichita | Kansas | 67207 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | United States |
| J Gary Booker, MD APMC | Shreveport | Louisiana | 71104 | United States |
| Pharmasite Research, Inc | Baltimore | Maryland | 21208 | United States |
| CBH Health | Rockville | Maryland | 20850 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| ActivMed Practices & Research, Inc. | Methuen | Massachusetts | 01844 | United States |
| BTC of New Bedford | New Bedford | Massachusetts | 02740 | United States |
| Coastal Research Associates | Weymouth | Massachusetts | 02190 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Millennium Psychiatric Associates | Olivette | Missouri | 63132 | United States |
| Center for Emotional Fitness | Cherry Hill | New Jersey | 08002 | United States |
| Pharmaceutical Research Associates Inc | Marlton | New Jersey | 08053 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Richard H. Weisler, MD, PA | Raleigh | North Carolina | 27609 | United States |
| Patient Priority Clinical Site, LLC | Cincinnati | Ohio | 45215 | United States |
| The Ohio State University Department of Psychiatry | Columbus | Ohio | 43210 | United States |
| Charak Clinical Research Center | Garfield Heights | Ohio | 44125 | United States |
| Lindner Center of Hope | Mason | Ohio | 45040 | United States |
| Professional Psychiatric Services | Mason | Ohio | 45040 | United States |
| Red River Medical Research Center, LLC | Oklahoma City | Oklahoma | 73112 | United States |
| Sooner Clinical Research, Inc | Oklahoma City | Oklahoma | 73112 | United States |
| Paradigm Research Professionals | Oklahoma City | Oklahoma | 73118 | United States |
| Summit Research Network | Portland | Oregon | 97210 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Carolina Clinical Trials, Inc. | Charleston | South Carolina | 29407 | United States |
| Coastal Carolina Research Center, Inc. | Mt. Pleasant | South Carolina | 29464 | United States |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | United States |
| BioBehavioral Research of Austin | Austin | Texas | 78759 | United States |
| Relaro Medical Trials | Dallas | Texas | 75243 | United States |
| El Campo Clinical Trials | El Campo | Texas | 77347 | United States |
| Earle Research | Houston | Texas | 77058 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| Family Psychiatry of The Wood | The Woodlands | Texas | 77381 | United States |
| PRA Health Sciences | Salt Lake City | Utah | 84106 | United States |
| Pacific Institute of Medical Sciences | Bothell | Washington | 98011 | United States |
| Eastside Therapeutic Resource | Everett | Washington | 98201 | United States |
Rapastinel 225 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. |
| FG002 | Rapastinel 450 mg | Rapastinel 450 mg 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. |
| Responder |
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| Non-Responder |
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| 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 225 mg | Rapastinel 225 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 | Rapastinel 450 mg | Rapastinel 450 mg 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. |
| BG003 | 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 | 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 |
|
| 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. | 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 |
|
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. | 0 | 217 | 1 | 217 | 14 | 217 |
| EG001 | Rapastinel 225 mg | Rapastinel 225 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 | 211 | 1 | 211 | 11 | 211 |
| EG002 | Rapastinel 450 mg | Rapastinel 450 mg 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 | 210 | 1 | 210 | 14 | 210 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Systematic Assessment |
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| Faecaloma | Gastrointestinal disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Systematic Assessment |
| |
| Large intestinal obstruction | Gastrointestinal 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 | Dec 11, 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 |
|
| American Indian or Alaska Native |
|
| Native Hawaiian or Other Pacific Islander |
|
| Multiple |
|
| Least Squares Mean Difference |
| -0.5 |
| 2-Sided |
| 95 |
| -2.07 |
| 1.16 |
| Superiority |
| OG002 |
| Rapastinel 450 mg |
Rapastinel 450 mg 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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