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This study will evaluate the safety and efficacy of onabotulinumtoxinA (BOTOX®) compared with placebo as treatment for major depressive disorder (MDD) in adult females.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo for onabotulinumtoxinA 50 U | Placebo Comparator | Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
|
| onabotulinumtoxinA 50 U | Experimental | OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
|
| Placebo for onabotulinumtoxinA 30 U | Placebo Comparator | Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. |
|
| onabotulinumtoxinA 30 U | Experimental | OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | OnabotulinumtoxinA injected into protocol-specified areas on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Baseline |
| Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score | The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shobhal Patel | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Woodland International Research Group | Little Rock | Alaska | 72211 | United States | ||
| CITrials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31609787 | Derived | Brin MF, Durgam S, Lum A, James L, Liu J, Thase ME, Szegedi A. OnabotulinumtoxinA for the treatment of major depressive disorder: a phase 2 randomized, double-blind, placebo-controlled trial in adult females. Int Clin Psychopharmacol. 2020 Jan;35(1):19-28. doi: 10.1097/YIC.0000000000000290. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Normal Saline) for onabotulinumtoxinA 50 U | Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
| FG001 | onabotulinumtoxinA 50 U |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Normal Saline | Drug | Placebo (normal saline) injected into protocol-specified areas on Day 1. |
|
| Baseline |
| Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score | The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | 24 Weeks |
| Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) | The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Baseline |
| Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) | The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | 24 Weeks |
| Bellflower |
| California |
| 90706 |
| United States |
| Radiant Research/Comprehensive Clinical Development, Inc. | Cerritos | California | 90703 | United States |
| Collaborative Neuroscience Network Inc. | Garden Grove | California | 92845 | United States |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | 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 |
| Schuster Medical Research Institute | Sherman Oaks | California | 91403 | United States |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | United States |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32256 | United States |
| Compass Research LLC-North Clinic | Leesburg | Florida | 34748 | United States |
| Research Centers of America, LLC | Oakland Park | Florida | 33334 | United States |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | United States |
| Compass Research, LLC | Orlando | Florida | 32806 | United States |
| Stedman Clinical Trials | Tampa | Florida | 33613 | United States |
| Institute for Advanced Medical Research | Alpharetta | Georgia | 30005 | United States |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | United States |
| iResearch Atlanta, LLC | Decatur | Georgia | 30030 | United States |
| Uptown Research Institute, LLC | Chicago | Illinois | 60640 | United States |
| Psychiatric Medicine Associates, LLC | Skokie | Illinois | 60076 | United States |
| St. Louis Clinical Trials, LLC | St Louis | Missouri | 63141 | United States |
| Integrative Clinical Trials | Brooklyn | New York | 11229 | United States |
| SPRI Clinical Trials | Brooklyn | New York | 11235 | United States |
| Finger Lakes Clinical Research | Rochester | New York | 14618 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Oklahoma Clinical Research Center | Oklahoma City | Oklahoma | 73112 | United States |
| Summit Research Network (Oregon) Inc. | Portland | Oregon | 97210 | United States |
| Clinical Neuroscience Solutions, INC | Memphis | Tennessee | 38119 | United States |
| KRK Medical Research | Dallas | Texas | 75230 | United States |
| InSite Clinical Research | DeSoto | Texas | 75115 | United States |
| Virginia Commonwealth University Clinical Research Services Unit | Richmond | Virginia | 23298 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | United States |
| Zain Research LLC | Richland | Washington | 99352 | United States |
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1.
| FG002 | Placebo (Normal Saline) for onabotulinumtoxinA 30 U | Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. |
| FG003 | onabotulinumtoxinA 30 U | OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Modified Intent to Treat: Enrolled subjects who received treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo (Normal Saline) for onabotulinumtoxinA 50 U | Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
| BG001 | onabotulinumtoxinA 50 U | OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
| BG002 | Placebo (Normal Saline) for onabotulinumtoxinA 30 U | Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. |
| BG003 | onabotulinumtoxinA 30 U | OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. |
| BG004 | 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, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Baseline Values for the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline Values in the Clinic 10-Item Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | The MADRS is a 10-item scale completed by clinic personnel that assesses the subject's symptoms of depression. Each question is answered on a 7-point scale ranging from no symptoms to worst possible symptoms. The total score is summed for all responses and ranges from 0 to 60. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point | Posted | Least Squares Mean | Standard Error | Scores on a Scale | Week 6 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Values for the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score | The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Values in the 7-Item Clinical Global Impression of Severity of Illness (CGI-S) Score | The CGI-S is a 7-point scale assessed by the clinician to rate the severity of the subject's symptoms. Scores range from 1 to 7, from normal (1, not at all ill) to among the most extremely ill patients (7). A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point | Posted | Least Squares Mean | Standard Error | Scores on a Scale | 24 Weeks |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) | The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline Values in the Clinic Hamilton Depression Rating Scale 17-Item Version (HAM-D17) | The HAM-D17 is assessed by the clinician based on subject interview. The total scores range from 0 to 53. A higher total score indicates more severe depression. A negative change from baseline indicates an improvement in symptoms and a positive change from baseline indicates a worsening. | Modified Intent to Treat: Enrolled subjects who received treatment with data at the noted time point | Posted | Least Squares Mean | Standard Error | Scores on a Scale | 24 Weeks |
|
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The Safety Population was used to assess AEs and SAEs and consisted of all randomized patients who received at least 1 injection of the study treatment
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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 (Normal Saline) for onabotulinumtoxinA 50 U | Placebo (normal saline) for onabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. | 5 | 67 | 21 | 67 | ||
| EG001 | onabotulinumtoxinA 50 U | OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. | 0 | 65 | 18 | 65 | ||
| EG002 | Placebo (Normal Saline) for onabotulinumtoxinA 30 U | Placebo (normal saline) for onabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. | 1 | 58 | 10 | 58 | ||
| EG003 | onabotulinumtoxinA 30 U | OnabotulinumtoxinA 30 U injected into protocol-specified areas on Day 1. | 3 | 65 | 21 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| Foot Fracture | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| Ligament Rupture | Injury, poisoning and procedural complications | MedDRA version 19.1 | Systematic Assessment |
| |
| Hallucination, Auditory | Psychiatric disorders | MedDRA version 19.1 | Non-systematic Assessment |
| |
| Suicidal Ideation | Psychiatric disorders | MedDRA version 19.1 | Non-systematic Assessment |
| |
| Varicose Vein | Vascular disorders | MedDRA version 19.1 | Non-systematic Assessment |
| |
| Sudden Death | General disorders | MedDRA version 19.1 | Systematic Assessment |
| |
| Benign Breast Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 19.1 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA version 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sinusitis | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| URI | Infections and infestations | MedDRA version 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 19.1 | Non-systematic Assessment |
| |
| Eyelid Ptosis | Eye disorders | MedDRA version 19.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 19.1 | Non-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 | |
|---|---|---|---|---|
| Arlene Lum, PMP | Allergan, Inc | 714-246-5548 | lum_arlene@allergan.com |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| ≥ 40 years |
|
| Male |
|
| OG003 | onabotulinumtoxinA 50 U | OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
|
|
| onabotulinumtoxinA 50 U |
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
|
|
| onabotulinumtoxinA 50 U |
OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
|
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OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
|
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OnabotulinumtoxinA 50 U injected into protocol-specified areas on Day 1. |
|
|