A Phase 3 interventional study of Placebo and Vilazadone in Generalized Anxiety Disorder, sponsored by Forest Laboratories. Completed at 30 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Forest Laboratories · Phase 3, Interventional, and Treatment
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).
4,864 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.
This study's enrollment of 402 is above the median of 80 across 4,170 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Forest Laboratories is the lead sponsor of 165 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with a history of meeting DSM-IV-TR criteria for:
Matching placebo tablets, oral administration
Drug: Placebo
Vilazadone tablets, oral administration
Drug: Vilazadone
Also known as: Dose-matched placebo tablets, oral administration, once per day
Viibryd
Also known as: Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
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.
Time frame: Baseline to Week 8
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).
Time frame: Baseline to Week 8
| Milestone | Placebo | Vilazadone |
|---|---|---|
| Started | 198 | 200 |
| Completed | 161 | 144 |
| Not completed | 37 | 56 |
| Withdrew: Adverse event | 7 | 22 |
| Withdrew: Lack of efficacy | 1 | 2 |
| Withdrew: Protocol violation | 3 | 8 |
| Withdrew: Withdrawal by subject | 15 | 12 |
| Withdrew: Lost to follow-up | 10 | 11 |
| Withdrew: Pregnancy | 1 | 1 |
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.
| Score on Scale | Placebo | Vilazadone |
|---|---|---|
| Change in Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 14.9 ± 7.37 | 13.5 ± 7.41 |
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).
| Score on Scale | Placebo | Vilazadone |
|---|---|---|
| Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | 10.1 ± 6.58 | 7.8 ± 6.91 |
Collected over Adverse events were collected until week 8.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/198 (0%) | 0/198 (0%) | 75/198 (37.9%) |
| Vilazadone | 0/200 (0%) | 0/200 (0%) | 130/200 (65%) |
| Event | Placebo | Vilazadone |
|---|---|---|
| NauseaGastrointestinal disorders | 19/198 | 63/200 |
| DiarrhoeaGastrointestinal disorders | 24/198 | 62/200 |
| HeadacheNervous system disorders | 21/198 | 15/200 |
| DizzinessNervous system disorders | 14/198 | 15/200 |
| VomitingGastrointestinal disorders | 2/198 | 13/198 |
| SomnolenceNervous system disorders | 6/198 | 12/200 |
| Dry mouthGastrointestinal disorders | 10/198 | 11/200 |
| Upper respiratory tract infectionInfections and infestations | 10/198 | 9/200 |
| Abnormal dreamsPsychiatric disorders | 3/198 | 10/200 |
The Safety Population consisted of all patients in the Randomized Population who took at least 1 dose of double-blind investigational product.
| Age, Continuous(Years) | Placebo | Vilazadone | Total |
|---|---|---|---|
| Mean | 40.1 ± 13.0 | 40.5 ± 13.2 | 40.3 ± 13.1 |
| Age, Customized(Participants) | Placebo | Vilazadone | Total |
|---|---|---|---|
| < 20 | 3 | 5 | 8 |
| 20-29 | 48 | 50 | 98 |
| 30-39 | 51 | 45 | 96 |
| 40-49 | 41 | 40 | 81 |
| 50-59 | 37 | 45 | 82 |
| ≥ 60 | 18 | 15 | 33 |
| Sex/Gender, Customized(Participants) | Placebo | Vilazadone | Total |
|---|---|---|---|
| Male | 67 | 55 | 122 |
| Female | 131 | 145 | 276 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Vilazadone | Total |
|---|---|---|---|
| Hispanic or Latino | 37 | 46 | 83 |
| Not Hispanic or Latino | 161 | 154 | 315 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | Vilazadone | Total |
|---|---|---|---|
| White | 160 | 164 | 324 |
| Black or African American | 32 | 23 | 55 |
| Asian | 3 | 9 | 12 |
| American Indian or Alaska Native | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Other | 2 | 1 | 3 |
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Forest Laboratories