A Phase 3 interventional study of Placebo and Vilazodone in Generalized Anxiety Disorder, sponsored by Forest Laboratories. Completed at 36 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).
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 415 is above the median of 80 across 4,174 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:
Dose-matched placebo tablets, oral administration
Drug: Placebo
Vilazodone tablets, oral administration
Drug: Vilazodone
Also known as: Matching 10 mg and 20 mg placebo tablets, once-daily oral administration.
Viibryd
Also known as: Vilazodone, 20 mg once per day, oral administration, once daily or Vilazodone, 40 mg once daily, oral administration, once daily
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.
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 | Vilazodone |
|---|---|---|
| Started | 202 | 202 |
| Completed | 163 | 144 |
| Not completed | 39 | 58 |
| Withdrew: Adverse event | 4 | 22 |
| Withdrew: Lack of efficacy | 1 | 4 |
| Withdrew: Protocol violation | 12 | 10 |
| Withdrew: Withdrawal by subject | 11 | 11 |
| Withdrew: Lost to follow-up | 11 | 10 |
| Withdrew: Pregnancy | 0 | 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 | Vilazodone |
|---|---|---|
| Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 14.7 ± 7.41 | 11.3 ± 6.99 |
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 | Vilazodone |
|---|---|---|
| Change From Baseline in the Sheehan Disability Scale (SDS) Total Score | 9.2 ± 6.96 | 7.4 ± 6.96 |
Collected over Adverse events were collected until week 8.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 0/202 (0%) | 0/202 (0%) | 81/202 (40.1%) |
| Vilazodone | 0/202 (0%) | 3/202 (1.5%) | 115/202 (56.9%) |
| Event | Placebo | Vilazodone |
|---|---|---|
| LacerationInjury, poisoning and procedural complications | 0/202 | 1/202 |
| Urinary tract infection,Infections and infestations | 0/202 | 1/202 |
| Impaired gastric emptyingGastrointestinal disorders | 0/202 | 1/202 |
| Stab woundInjury, poisoning and procedural complications | 0/202 | 1/202 |
| Event | Placebo | Vilazodone |
|---|---|---|
| NauseaGastrointestinal disorders | 26/202 | 60/202 |
| DiarrhoeaGastrointestinal disorders | 12/202 | 56/202 |
| HeadacheNervous system disorders | 36/202 | 22/202 |
| DizzinessNervous system disorders | 8/202 | 22/202 |
| InsomniaPsychiatric disorders | 8/202 | 15/202 |
| Dry mouthGastrointestinal disorders | 12/202 | 12/202 |
| SomnolenceNervous system disorders | 6/202 | 12/202 |
| Upper respiratory tract infectionInfections and infestations | 11/202 | 5/202 |
| Ejaculation delayed +Reproductive system and breast disorders | 1/65 | 4/75 |
| Erectile dysfunction +Reproductive system and breast disorders | 1/65 | 4/75 |
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 | Vilazodone | Total |
|---|---|---|---|
| Mean | 40.7 ± 13.4 | 39.2 ± 12.8 | 39.9 ± 13.1 |
| Age, Customized(Participants) | Placebo | Vilazodone | Total |
|---|---|---|---|
| < 20 | 4 | 2 | 6 |
| 20-29 | 53 | 56 | 109 |
| 30-39 | 42 | 55 | 97 |
| 40-49 | 46 | 42 | 88 |
| 50-59 | 36 | 26 | 62 |
| ≥ 60 | 21 | 21 | 42 |
| Sex/Gender, Customized(Participants) | Placebo | Vilazodone | Total |
|---|---|---|---|
| Male | 65 | 75 | 140 |
| Female | 137 | 127 | 264 |
| Ethnicity (NIH/OMB)(Participants) | Placebo | Vilazodone | Total |
|---|---|---|---|
| Hispanic or Latino | 25 | 22 | 47 |
| Not Hispanic or Latino | 177 | 180 | 357 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Placebo | Vilazodone | Total |
|---|---|---|---|
| White | 153 | 158 | 311 |
| Black or African American | 38 | 33 | 71 |
| Asian | 5 | 4 | 9 |
| American Indian or Alaska Native | 1 | 1 | 2 |
| Other | 5 | 6 | 11 |
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Forest Laboratories