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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 tablets, oral administration |
|
| Vilazodone | Experimental | Vilazodone tablets, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
|
| |
| 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 or who will be breastfeeding during the study
Patients with a history of:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanna Forero, MA | Forest Research Institute, a subsidiary of Actavis plc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 023 | Birmingham | Alabama | 35216 | United States | ||
| Forest Investigative Site 013 |
| 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. | |
| 27232052 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose-matched placebo tablets, oral administration |
| FG001 | Vilazodone | Vilazodone tablets, oral administration |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vilazodone |
| Drug |
Viibryd |
|
|
| Baseline to Week 8 |
| Phoenix |
| Arizona |
| 85032 |
| United States |
| Forest Investigative Site 036 | Beverly Hills | California | 90210 | United States |
| Forest Investigative Site 001 | Costa Mesa | California | 92626 | United States |
| Forest Investigative Site 009 | Oceanside | California | 92056 | United States |
| Forest Investigative Site 026 | Rancho Mirage | California | 92270 | United States |
| Forest Investigative Site 017 | Sherman Oaks | California | 91403 | United States |
| Forest Investigative Site 034 | Sherman Oaks | California | 91403 | United States |
| Forest Investigative Site 030 | Bradenton | Florida | 34201 | United States |
| Forest Investigative Site 029 | Gainesville | Florida | 32607 | United States |
| Forest Investigative Site 035 | Jacksonville | Florida | 32256 | United States |
| Forest Investigative Site 032 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 021 | West Palm Beach | Florida | 33407 | United States |
| Forest Investigative Site 025 | Atlanta | Georgia | 30328 | United States |
| Forest Investigative Site 018 | Decatur | Georgia | 30030 | United States |
| Forest Investigative Site 022 | Hoffman Estates | Illinois | 60169 | United States |
| Forest Investigative Site 014 | Berlin | New Jersey | 08009 | United States |
| Forest Investigative Site 005 | Cherry Hill | New Jersey | 08002 | United States |
| Forest Investigative Site 015 | Albuquerque | New Mexico | 87109 | United States |
| Forest Investigative Site 028 | Brooklyn | New York | 11214 | United States |
| Forest Investigative Site 010 | Brooklyn | New York | 11235 | United States |
| Forest Investigative Site 002 | Cedarhurst | New York | 11516 | United States |
| Forest Investigative Site 004 | Mount Kisco | New York | 10549 | United States |
| Forest Investigative Site 003 | New York | New York | 10003 | United States |
| Forest Investigative Site 007 | New York | New York | 10021 | United States |
| Forest Investigative Site 020 | New York | New York | 10168 | United States |
| Forest Investigative Site 027 | The Bronx | New York | 10467 | United States |
| Forest Investigative Site 019 | Dayton | Ohio | 45417 | United States |
| Forest Investigative Site 008 | Portland | Oregon | 97210 | United States |
| Forest Investigative Site 037 | Allentown | Pennsylvania | 18104 | United States |
| Forest Investigative Site 011 | Media | Pennsylvania | 19063 | United States |
| Forest Investigative Site 033 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 031 | Dallas | Texas | 75231 | United States |
| Forest Investigative Site 012 | Herndon | Virginia | 20170 | United States |
| Forest Investigative Site 016 | Bellevue | Washington | 98007 | United States |
| Forest Investigative Site 024 | Seattle | Washington | 98104 | United States |
| Durgam S, Gommoll C, Forero G, Nunez R, Tang X, Mathews M, Sheehan DV. Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial. J Clin Psychiatry. 2016 Dec;77(12):1687-1694. doi: 10.4088/JCP.15m09885. |
| 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 tablets, oral administration |
| BG001 | Vilazodone | Vilazodone tablets, oral administration |
| BG002 | 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 |
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| Age, Customized | Number | Participants |
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| Sex/Gender, Customized | Number | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
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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 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 the 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 the 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 tablets, oral administration | 0 | 202 | 0 | 202 | 81 | 202 |
| EG001 | Vilazodone | Vilazodone tablets, oral administration | 0 | 202 | 3 | 202 | 115 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Laceration | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Systematic Assessment |
| |
| Urinary tract infection, | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Stab wound | Injury, poisoning and procedural complications | MedDRA Version 16.1 | Systematic Assessment |
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| 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 |
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| Dry mouth | Gastrointestinal disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Ejaculation delayed + | Reproductive system and breast disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Erectile dysfunction + | Reproductive system and breast 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 investigator will be subject to mutual agreement between the investigator 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 |
| D000284 | Administration, Oral |
| 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 |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 20-29 |
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| 30-39 |
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| 40-49 |
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| 50-59 |
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| ≥ 60 |
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| Female |
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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 |
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| American Indian or Alaska Native |
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| Other |
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