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Study stopped due to business reasons.
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The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) of Rapastinel, compared to placebo in adult patients with major depressive disorder (MDD) who are at imminent risk of suicide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapastinel 450mg | Experimental | Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. |
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| Placebo | Placebo Comparator | Placebo-matching rapastinel weekly IV injections. |
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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 | 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 and 1 Day |
| Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score | The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency. | Baseline and 1 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 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:
DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 1 month before Visit 1.
Lifetime history or currently meet DSM-5 criteria for:
Significant homicidal ideation or at imminent risk of injuring others or causing significant damage to property, as judged by the investigator.
Prior participation in any investigational study of rapastinel/GLYX-13
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| Name | Affiliation | Role |
|---|---|---|
| Jenna Hoogerheyde | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Board of Trustees of the University of Alabama for the University of Alabama at Birmingham | Birmingham | Alabama | 35294-0107 | United States |
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| Label | URL |
|---|---|
| Additional information on study locations near you may be found at AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo-matching rapastinel weekly IV injections. |
| FG001 | Rapastinel 450mg | Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. |
| 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 20, 2019 | Jun 18, 2020 |
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| Placebo |
| Drug |
Placebo-matching rapastinel pre-filled syringes for weekly IV injections. |
|
| Baseline and 28 Days |
| Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score | The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency. | Baseline and 28 Days |
| Collaborative NeuroScience Network, LLC | Garden Grove | California | 92845 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206-4282 | United States |
| Asclepes Research Centers | Panorama City | California | 91402 | United States |
| Institute of Living | Hartford | Connecticut | 06106 | United States |
| Innovative Clinical Research, Inc | Hialeah | Florida | 33012 | United States |
| Research Centers of America, LLC | Oakland Park | Florida | 33334 | United States |
| Atlanta Center for Medical Research (ACMR) | Atlanta | Georgia | 30331 | United States |
| Alexian Brothers Center for Psychiatric Research | Hoffman Estates | Illinois | 60169 | United States |
| Lake Charles Clinical Trials | Lake Charles | Louisiana | 70629 | United States |
| CBH Health | Gaithersburg | Maryland | 20877 | United States |
| Altea Research Institute | Las Vegas | Nevada | 89102 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Cincinnati VA Medical Center | Cincinnati | Ohio | 45220-2288 | United States |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | United States |
| Carilion Medical Center, a Virginia Nonprofit Corporation | Roanoke | Virginia | 24014-2419 | United States |
| Department of Veterans Affairs Salem VA Medical Center | Salem | Virginia | 24153 | United States |
| COMPLETED |
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| NOT COMPLETED |
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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-matching rapastinel weekly IV injections. |
| BG001 | Rapastinel 450mg | Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. |
| 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 (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 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 | Scores on a scale |
| ||||||||||||||
| Sheehan - Suicidality Tracking Scale (S-STS) Total Score (Patient-rated) | The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency. | Mean | Standard Deviation | Scores on a scale |
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| Weight | Mean | Standard Deviation | kg |
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| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| S-STS Total Score (Clinician-rated) | The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency. | 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 | 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 consists of all participants 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 and 1 Day |
|
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| Primary | Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score | The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency. | The modified Intent-to-Treat (mITT) Population consists 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 and 1 Day |
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| Secondary | Change From Baseline in Montgomery-Asberg Depression Rating Scale (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 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 consists of all participants 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 and 28 Days |
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| Secondary | Change From Baseline in Sheehan - Suicidality Tracking Scale (S-STS) Total Score | The S-STS is a patient-report informed, clinician-rated scale used to rate the severity of suicidal impulses, thoughts, and behaviors. This is a 14 item scale ranging from 0=Not at all to 4= Extremely. The total score ranges from 0 to 56 with a higher score indicating higher suicidal tendency. | The modified Intent-to-Treat (mITT) Population consists 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 and 28 Days |
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The study consisted of a 4 week double-blind treatment period, followed by a 1-week safety follow-up period.
The Safety Population will consist of all patients in the Randomized Population who took 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-matching rapastinel weekly IV injections. | 0 | 64 | 5 | 64 | 18 | 64 |
| EG001 | Rapastinel 450mg | Rapastinel 450 milligram (mg) weekly intravenous (IV) injections. | 0 | 72 | 12 | 72 | 21 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Depressive Symptom | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Major Depression | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA Version 22.0 | Systematic Assessment |
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| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Mitral Valve Incompetence | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Mitral Valve Prolapse | Cardiac disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 22.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 22.0 | Systematic Assessment |
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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 | Sep 26, 2017 | Jun 18, 2020 | Prot_001.pdf |
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| 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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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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