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Business decision to stop the program.
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The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) and 900 milligrams (mg) of Rapastinel, compared to placebo in participants with major depressive disorder (MDD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapastinel 450mg | Experimental | Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration) |
|
| Rapastinel 900mg | Experimental | Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration) |
|
| Placebo | Placebo Comparator | Placebo (prefilled syringe, weekly IV administration) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rapastinel | Drug | Rapastinel (prefilled syringe, weekly intravenous IV administration) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6) | 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 a 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 to end of Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment | 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 a 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:
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| Name | Affiliation | Role |
|---|---|---|
| Jenna Hoogerheyde | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alea Research | Phoenix | Arizona | 85012 | United States | ||
| Woodland International Research Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (prefilled syringe, weekly IV administration) |
| FG001 | Rapastinel 450mg | Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double Blind Treatment Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 22, 2019 | Jul 7, 2020 |
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| Placebo | Drug | Placebo (prefilled syringe, weekly IV administration) |
|
| Baseline to Day 1 post-first dose |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| California Pharmaceutical Research Institute, Inc. | Anaheim | California | 92804 | United States |
| Collaborative Neuroscience Network | Garden Grove | California | 92845 | United States |
| Synergy Research San Diego | National City | California | 91950 | United States |
| Excell Research Inc. | Oceanside | California | 92056 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| California Neuroscience Research Medical Group,Inc. | Sherman Oaks | California | 91403 | United States |
| Viking Clinical Research Ltd. | Temecula | California | 92591 | United States |
| Pacific Clinical Research Medical Group | Upland | California | 91786 | United States |
| Research Centers of America, LLC | Hollywood | Florida | 33024 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Innovative Clinical Research, Inc. | Lauderhill | Florida | 33319 | United States |
| Innova Clinical Trials | Miami | Florida | 33133 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| Institute for Advanced Medical Research | Atlanta | Georgia | 30341 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Iris Research, Inc. | Smyrna | Georgia | 30082 | United States |
| Capstone Clinical Research | Libertyville | Illinois | 60048 | United States |
| Pharmasite Research, Inc. | Baltimore | Maryland | 21208 | United States |
| CBH Health, LLC | Gaithersburg | Maryland | 20877 | United States |
| Boston Clinical Trials | Boston | Massachusetts | 02131 | United States |
| Adams Clinical | Watertown | Massachusetts | 02472 | United States |
| Precise Research Centers | Flowood | Mississippi | 39232 | United States |
| Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri | 63141 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Hassman Research Institute | Berlin | New Jersey | 08009 | United States |
| Bioscience Research LLC | Mount Kisco | New York | 10549 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10028 | United States |
| Eastside Comprehensive Medical Center, LLC | New York | New York | 10128 | United States |
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| New Hope Clinical Research Inc. | Charlotte | North Carolina | 28211 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19063 | United States |
| Keystone Clinical Studies, LLC | Norristown | Pennsylvania | 19403 | United States |
| Donald J. Garcia, Jr., MD, PA | Austin | Texas | 78737 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| FG002 | Rapastinel 900mg | Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-Up Period |
|
The modified Intent-to-Treat (mITT) Population will consist of all patients in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score or S-STS total score.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (prefilled syringe, weekly IV administration) |
| BG001 | Rapastinel 450mg | Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration) |
| BG002 | Rapastinel 900mg | Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration) |
| 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 (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Montgomery-Asberg Depression Rating Scale (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 a 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. | 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 on Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Treatment (End of Week 6) | 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 a 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 in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score or S-STS total score. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to end of Week 6 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in MADRS Total Score at Day 1 Post-first Dose of Treatment | 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 a 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 in the Safety Population who had at least 1 postbaseline assessment of the MADRS total score or S-STS total score. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline to Day 1 post-first dose |
|
The study consisted of a 6 week double-blind treatment period, followed by a 2-week safety follow-up period.
The Safety Population consists of all randomized patients who received at least 1 dose of randomized IP.
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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 (prefilled syringe, weekly IV administration) | 0 | 147 | 2 | 147 | 15 | 147 |
| EG001 | Rapastinel 450mg | Rapastinel 450 mg (prefilled syringe, weekly intravenous IV administration) | 1 | 145 | 2 | 145 | 28 | 145 |
| EG002 | Rapastinel 900mg | Rapastinel 900 mg (prefilled syringe, weekly intravenous IV administration) | 0 | 147 | 1 | 147 | 21 | 147 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Abortion induced | Surgical and medical procedures | MedDRA Version 22.0 | Systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
|
Due to study termination, the target number of participants needed to achieve target power and statistically reliable results was not met.
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 |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 10, 2018 | Jul 7, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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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| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
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