Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo tablets, oral administration |
|
| Vilazadone | Experimental | Vilazadone tablets, oral administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 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). |
Not provided
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
Patients with a history of meeting DSM-IV-TR criteria for:
Patients who are considered a suicide risk
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Giovanna Forero, MA | Forest Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forest Investigative Site 022 | Arcadia | California | 91007 | United States | ||
| Forest Investigative Site 023 |
| 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. | |
| 26291335 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Dose-matched placebo tablets, oral administration, once per day |
| FG001 | Vilazadone | Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Vilazadone |
| Drug |
Viibryd |
|
|
| Baseline to Week 8 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Forest Investigative Site 010 | Encino | California | 91316 | United States |
| Forest Investigative Site 025 | Newport Beach | California | 92660 | United States |
| Forest Investigative Site 004 | Redlands | California | 92374 | United States |
| Forest Investigative Site 007 | Sherman Oaks | California | 91403 | United States |
| Forest Investigative Site 016 | Temecula | California | 92562 | United States |
| Forest Investigative Site 012 | Upland | California | 91786 | United States |
| Forest Investigative Site 017 | Coral Springs | Florida | 33067 | United States |
| Forest Investigative Site 028 | Fort Myers | Florida | 33912 | United States |
| Forest Investigative Site 002 | Jacksonville | Florida | 32256 | United States |
| Forest Investigative Site 020 | Leesburg | Florida | 34748 | United States |
| Forest Investigative Site 024 | Miami | Florida | 33015 | United States |
| Forest Investigative Site 001 | Orlando | Florida | 32806 | United States |
| Forest Investigative Site 026 | Indianapolis | Indiana | 46260 | United States |
| Forest Investigative Site 029 | Shreveport | Louisiana | 71104 | United States |
| Forest Investigative Site 019 | Las Vegas | Nevada | 89102 | United States |
| Forest Investigative Site 003 | Canton | Ohio | 44718 | United States |
| Forest Investigative Site 031 | Columbus | Ohio | 43210 | United States |
| Forest Investigative Site 021 | Mason | Ohio | 45040 | United States |
| Forest Investigative Site 030 | Oklahoma City | Oklahoma | 73112 | United States |
| Forest Investigative Site 005 | Salem | Oregon | 97301 | United States |
| Forest Investigative Site 014 | Allentown | Pennsylvania | 18104 | United States |
| Forest Investigative Site 015 | Philadelphia | Pennsylvania | 19139 | United States |
| Forest Investigative Site 027 | Lincoln | Rhode Island | 02865 | United States |
| Forest Investigative Site 006 | Memphis | Tennessee | 38119 | United States |
| Forest Investigative Site 008 | Houston | Texas | 77054 | United States |
| Forest Investigative Site 018 | Houston | Texas | 77096 | United States |
| Forest Investigative Site 011 | Murray | Utah | 84123 | United States |
| Forest Investigative Site 013 | Woodstock | Vermont | 05091 | United States |
| Gommoll C, Forero G, Mathews M, Nunez R, Tang X, Durgam S, Sambunaris A. Vilazodone in patients with generalized anxiety disorder: a double-blind, randomized, placebo-controlled, flexible-dose study. Int Clin Psychopharmacol. 2015 Nov;30(6):297-306. doi: 10.1097/YIC.0000000000000096. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Dose-matched placebo tablets, oral administration, once per day |
| BG001 | Vilazadone | Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, 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 |
| |||||||||||||||
| 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 in 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 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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.
Not provided
| 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, once per day | 0 | 198 | 0 | 198 | 75 | 198 |
| EG001 | Vilazadone | Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration. | 0 | 200 | 0 | 200 | 130 | 200 |
Not provided
| 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 |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 16.1 | Systematic Assessment |
| |
| Abnormal dreams | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000284 | Administration, Oral |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| 20-29 |
|
| 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 |
|
| Native Hawaiian or Other Pacific Islander |
|
| Other |
|
|
|