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The purpose of this study is to evaluate the efficacy, safety and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (GAD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Dose-matched placebo one per day, oral administration |
|
| Vilazadone 20mg | Experimental | Vilazodone 20mg once per day, oral administration. |
|
| Vilazodone 40mg | Experimental | Vilazodone 40mg once per day, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching 10 mg and 20 mg placebo tablets, once per day, oral administration, |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety. | Baseline to Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe). |
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Inclusion Criteria:
Exclusion Criteria:
Women who are pregnant, women who will be breastfeeding during the study and women of childbearing potential who are not practicing a reliable method of birth control
History of meeting DSM-IV-TR criteria for any of the following:
Patients who are considered a suicide risk
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| Name | Affiliation | Role |
|---|---|---|
| Giovanna Forero, MA | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 001 | Birmingham | Alabama | 35216 | United States | ||
| Forest Investigative Site 021 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27486544 | Derived | Khan A, Durgam S, Tang X, Ruth A, Mathews M, Gommoll CP. Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone. Prim Care Companion CNS Disord. 2016 Apr 28;18(2):10.4088/PCC.15m01904. doi: 10.4088/PCC.15m01904. eCollection 2016. | |
| 25891440 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose-matched placebo one per day, oral administration |
| FG001 | Vilazadone 20mg | Vilazodone 20mg once per day, oral administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vilazodone |
| Drug |
Vilazodone, 20mg, oral administration once per day. |
|
| Vilazodone | Drug | Vilazodone, 40mg, oral administration once per day. |
|
| Baseline to Week 8 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Forest Investigative Site 023 | Glendale | California | 91204 | United States |
| Forest Investigative Site 011 | Paramount | California | 90723 | United States |
| Forest Investigative Site 026 | Norwich | Connecticut | 06360 | United States |
| Forest Investigative Site 027 | Waterbury | Connecticut | 06708 | United States |
| Forest Investigative Site 005 | Delray Beach | Florida | 33484 | United States |
| Forest Investigative Site 014 | Oakland Park | Florida | 33334 | United States |
| Forest Investigative Site 019 | South Miami | Florida | 33143 | United States |
| Forest Investigative Site 038 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 035 | Decatur | Georgia | 30030 | United States |
| Forest Investigative Site 028 | Chicago | Illinois | 60634 | United States |
| Forest Investigative Site 030 | Schaumburg | Illinois | 60194 | United States |
| Forest Investigative Site 029 | Topeka | Kansas | 66606 | United States |
| Forest Investigative Site 033 | Wichita | Kansas | 67207 | United States |
| Forest Investigative Site 010 | Lake Charles | Louisiana | 70629 | United States |
| Forest Investigative Site 031 | Baltimore | Maryland | 21208 | United States |
| Forest Investigative Site 025 | Boston | Massachusetts | 02114 | United States |
| Forest Investigative Site 037 | St Louis | Missouri | 63104 | United States |
| Forest Investigative Site 015 | Las Vegas | Nevada | 89103 | United States |
| Forest Investigative Site 016 | Berlin | New Jersey | 08009 | United States |
| Forest Investigative Site 007 | Brooklyn | New York | 11235 | United States |
| Forest Investigative Site 024 | New York | New York | 10003 | United States |
| Forest Investigative Site 032 | New York | New York | 10023 | United States |
| Forest Investigative Site 012 | New York | New York | 10168 | United States |
| Forest Investigative Site 020 | Bismarck | North Dakota | 58501 | United States |
| Forest Investigative Site 008 | Cincinnati | Ohio | 45215 | United States |
| Forest Investigative Site 041 | Dayton | Ohio | 45414 | United States |
| Forest Investigative Site 004 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 034 | Oklahoma City | Oklahoma | 73116 | United States |
| Forest Investigative Site 013 | Portland | Oregon | 97210 | United States |
| Forest Investigative Site 006 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 017 | Wichita Falls | Texas | 76309 | United States |
| Forest Investigative Site 003 | Salt Lake City | Utah | 84106 | United States |
| Forest Investigative Site 018 | Charlottesville | Virginia | 22911 | United States |
| Forest Investigative Site 040 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 039 | Seattle | Washington | 98104 | United States |
| Gommoll C, Durgam S, Mathews M, Forero G, Nunez R, Tang X, Thase ME. A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder. Depress Anxiety. 2015 Jun;32(6):451-9. doi: 10.1002/da.22365. Epub 2015 Apr 17. |
| FG002 | Vilazodone 40mg | Vilazodone 40mg once per day, oral administration |
| COMPLETED |
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| NOT COMPLETED |
|
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The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dose-matched placebo one per day, oral administration |
| BG001 | Vilazadone 20mg | Vilazodone 20mg once per day, oral administration. |
| BG002 | Vilazodone 40mg | Vilazodone 40mg once per day, oral 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 |
| |||||||||||||||
| Age, Customized | Number | Participants |
| ||||||||||||||||
| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale which consists of 14 items, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The highest possible score is 56, which represents the most severe form of anxiety; the lowest possible score is 0, which represents an absence of anxiety. | The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A. | Posted | Mean | Standard Deviation | Score on scale | Baseline to Week 8 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | The Sheehan Disability Scale (SDS) is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0 = no impairment to 10 = most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe). | The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A. | Posted | Mean | Standard Deviation | Score on Scale | Baseline to Week 8 |
|
|
Adverse events were collected until week 8.
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
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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 | Dose-matched placebo one per day, oral administration | 0 | 221 | 1 | 221 | 85 | 221 |
| EG001 | Vilazadone 20mg | Vilazodone 20mg once per day, oral administration. | 0 | 227 | 1 | 227 | 123 | 227 |
| EG002 | Vilazodone 40mg | Vilazodone 40mg once per day, oral administration | 0 | 225 | 0 | 225 | 121 | 225 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| left carpal canal hematoma | Blood and lymphatic system disorders | MedDRA Version 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
|
All data generated in this study will be the property of Forest Research Institute, Inc. An integrated clinical and statistical report will be prepared at the completion of the study. Publication of the results by the PI will be subject to mutual agreement between the PI and Forest Research Institute, Inc.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Forest Research Institute, Inc | 877-277-8566 | IR-CTRegistration@allergan.com |
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |
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| 20-29 |
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| 30-39 |
|
| 40-49 |
|
| 50-59 |
|
| ≥ 60 |
|
| Female |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Asian |
|
| American Indian or Alaska Native |
|
| Other |
|
| Least Squares Mean Difference |
| -1.80 |
| 2-Sided |
| 95 |
| -3.26 |
| -0.34 |
| Superiority |
| Participants |
|
|
|