Generalized Anxiety DisorderPhase 3NCT01844115
Safety, Efficacy and Tolerability of Vilazodone in (GAD) Generalized Anxiety Disorder
A Phase 3 study testing Vilazodone in people with Generalized Anxiety Disorder, run by Forest Laboratories at 36 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Vilazodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 415 participants
- Where
- 36 sitesUnited States
- Study dates
- 30 Apr 2013to 31 Mar 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatient, 18-70 years of age
- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder
- Minimum score of 20 on Hamilton Rating Scale for Anxiety
Who cannot join
- Women who are pregnant or who will be breastfeeding during the study
- Patients with a history of:
- Any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode
- Any depressive episode with psychotic or catatonic features
- Panic disorder with or without agoraphobia
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Forest Investigative Site 015
Albuquerque, New Mexico, 87109
Forest Investigative Site 037
Allentown, Pennsylvania, 18104
Forest Investigative Site 025
Atlanta, Georgia, 30328
Forest Investigative Site 016
Bellevue, Washington, 98007
Forest Investigative Site 014
Berlin, New Jersey, 08009
Forest Investigative Site 036
Beverly Hills, California, 90210
Forest Investigative Site 023
Birmingham, Alabama, 35216
Forest Investigative Site 030
Bradenton, Florida, 34201
Forest Investigative Site 028
Brooklyn, New York, 11214
Forest Investigative Site 010
Brooklyn, New York, 11235
Forest Investigative Site 002
Cedarhurst, New York, 11516
Forest Investigative Site 005
Cherry Hill, New Jersey, 08002
Forest Investigative Site 001
Costa Mesa, California, 92626
Forest Investigative Site 031
Dallas, Texas, 75231
Forest Investigative Site 019
Dayton, Ohio, 45417
Forest Investigative Site 018
Decatur, Georgia, 30030
Forest Investigative Site 029
Gainesville, Florida, 32607
Forest Investigative Site 012
Herndon, Virginia, 20170
Forest Investigative Site 022
Hoffman Estates, Illinois, 60169
Forest Investigative Site 035
Jacksonville, Florida, 32256
Forest Investigative Site 011
Media, Pennsylvania, 19063
Forest Investigative Site 033
Memphis, Tennessee, 38119
Forest Investigative Site 004
Mount Kisco, New York, 10549
Forest Investigative Site 003
New York, New York, 10003
Forest Investigative Site 007
New York, New York, 10021
Forest Investigative Site 020
New York, New York, 10168
Forest Investigative Site 009
Oceanside, California, 92056
Forest Investigative Site 032
Orlando, Florida, 32806
Forest Investigative Site 013
Phoenix, Arizona, 85032
Forest Investigative Site 008
Portland, Oregon, 97210
Forest Investigative Site 026
Rancho Mirage, California, 92270
Forest Investigative Site 024
Seattle, Washington, 98104
Forest Investigative Site 017
Sherman Oaks, California, 91403
Forest Investigative Site 034
Sherman Oaks, California, 91403
Forest Investigative Site 027
The Bronx, New York, 10467
Forest Investigative Site 021
West Palm Beach, Florida, 33407
About this study
Official title: A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
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).
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Placebo, Vilazodone
- Keywords
- Generalized Anxiety Disorder, GAD
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Matching 10 mg and 20 mg placebo tablets, once-daily oral administration.
VilazodoneDrug
Also called Vilazodone, 20 mg once per day, oral administration, once daily or Vilazodone, 40 mg once daily, oral administration, once daily
Viibryd
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Dose-matched placebo tablets, oral administration Receives: Drug: Placebo |
| Vilazodone | Experimental | Vilazodone tablets, oral administration Receives: Drug: Vilazodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Week 8
Secondary outcomes (1)
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).
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study start30 Apr 2013
- Primary completion31 Mar 2014
- Study completion31 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forest Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giovanna Forero, MA, Study director, Forest Research Institute, a subsidiary of Actavis plc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844115
- Sponsor's protocol ID
- VLZ-MD-07
- Status last verified
- Nov 2019
- First submitted
- 27 Apr 2013
- Last updated
- 18 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27486544Durgam 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.
PubMed 27232052
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
- ClinicalTrials.gov ID
- NCT01844115
- Acronym / sponsor ID
- VLZ-MD-07
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Generalized Anxiety Disorder, GAD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- Forest LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2013 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 31 Mar 2014 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 18 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboDose-matched placebo tablets, oral administration |
| Vilazodone | Experimental | Drug: VilazodoneVilazodone tablets, oral administration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female outpatient, 18-70 years of age
- Currently meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for Generalized Anxiety Disorder
- Minimum score of 20 on Hamilton Rating Scale for Anxiety
Key exclusion criteria (5 listed)
- Women who are pregnant or who will be breastfeeding during the study
- Patients with a history of:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Matching 10 mg and 20 mg placebo tablets, once-daily oral administration. | Drug | Placebo |
| VilazodoneAlso: Vilazodone, 20 mg once per day, oral administration, once daily or Vilazodone, 40 mg once daily, oral administration, once dailyViibryd | Drug | Vilazodone |
Primary outcome
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
Time frame: Baseline to Week 8
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.
1 secondary outcome
Change From Baseline in the Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline to Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27486544Khan 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.
- Derived from this study: PubMed 27232052Durgam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giovanna Forero, MA study director
Forest Research Institute, a subsidiary of Actavis plc.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vilazodone in people with Generalized Anxiety Disorder, run by Forest Laboratories at 36 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01844115, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2019.