Generalized Anxiety DisorderPhase 3VLZ-MD-05NCT01629966

Safety, Efficacy and Tolerability of Vilazodone in Generalized Anxiety Disorder

A Phase 3 study testing Vilazodone in people with Generalized Anxiety Disorder, run by Forest Laboratories at 37 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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: 680 participants
Where: 37 sitesUnited States
Study dates: 30 Jun 2012to 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 and female, 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 (GAD)
Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

Who cannot join

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
History of meeting DSM-IV-TR criteria for any of the following:
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
Obsessive-compulsive disorder

Show all 11Show fewer

Schizophrenia, schizoaffective, or other psychotic disorder
Bulimia or anorexia nervosa
Presence of borderline personality disorder or antisocial personality disorder
Mental retardation, dementia, amnesia, or other significant cognitive disorders
Patients who are considered a suicide risk

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Forest Investigative Site 038
Atlanta, Georgia, 30328
Forest Investigative Site 031
Baltimore, Maryland, 21208
Forest Investigative Site 040
Bellevue, Washington, 98007
Forest Investigative Site 016
Berlin, New Jersey, 08009
Forest Investigative Site 021
Beverly Hills, California, 90210
Forest Investigative Site 001
Birmingham, Alabama, 35216
Forest Investigative Site 020
Bismarck, North Dakota, 58501
Forest Investigative Site 025
Boston, Massachusetts, 02114
Forest Investigative Site 007
Brooklyn, New York, 11235
Forest Investigative Site 018
Charlottesville, Virginia, 22911
Forest Investigative Site 028
Chicago, Illinois, 60634
Forest Investigative Site 008
Cincinnati, Ohio, 45215
Forest Investigative Site 041
Dayton, Ohio, 45414
Forest Investigative Site 035
Decatur, Georgia, 30030
Forest Investigative Site 005
Delray Beach, Florida, 33484
Forest Investigative Site 023
Glendale, California, 91204
Forest Investigative Site 010
Lake Charles, Louisiana, 70629
Forest Investigative Site 015
Las Vegas, Nevada, 89103
Forest Investigative Site 006
Memphis, Tennessee, 38119
Forest Investigative Site 024
New York, New York, 10003
Forest Investigative Site 032
New York, New York, 10023
Forest Investigative Site 012
New York, New York, 10168
Forest Investigative Site 026
Norwich, Connecticut, 06360
Forest Investigative Site 014
Oakland Park, Florida, 33334
Forest Investigative Site 004
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 034
Oklahoma City, Oklahoma, 73116
Forest Investigative Site 011
Paramount, California, 90723
Forest Investigative Site 013
Portland, Oregon, 97210
Forest Investigative Site 003
Salt Lake City, Utah, 84106
Forest Investigative Site 030
Schaumburg, Illinois, 60194
Forest Investigative Site 039
Seattle, Washington, 98104
Forest Investigative Site 019
South Miami, Florida, 33143
Forest Investigative Site 037
St Louis, Missouri, 63104
Forest Investigative Site 029
Topeka, Kansas, 66606
Forest Investigative Site 027
Waterbury, Connecticut, 06708
Forest Investigative Site 033
Wichita, Kansas, 67207
Forest Investigative Site 017
Wichita Falls, Texas, 76309

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About this study

Official title: A Double-blind, Placebo-Controlled Fixed-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
Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,
VilazodoneDrug
Vilazodone, 20mg, oral administration once per day.
VilazodoneDrug
Vilazodone, 40mg, oral administration once per day.

Study groups in NCT01629966
Study group	Role	What they receive
Placebo	Placebo comparator	Dose-matched placebo one per day, oral administration Receives: Drug: Placebo
Vilazadone 20mg	Experimental	Vilazodone 20mg once per day, oral administration. Receives: Drug: Vilazodone
Vilazodone 40mg	Experimental	Vilazodone 40mg once per day, 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.

30 Jun 201231 Mar 2014

First posted28 Jun 2012 (estimated)
Study start30 Jun 2012
Primary completion28 Feb 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: 680 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01629966
Sponsor's protocol ID: VLZ-MD-05
Acronym: VLZ-MD-05
Status last verified: Nov 2019
First submitted: 26 Jun 2012
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 27486544
Gommoll C, Durgam S, Mathews M, Forero G, Nunez R, Tang X, Thase ME. A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder. Depress Anxiety. 2015 Jun;32(6):451-9. doi: 10.1002/da.22365. Epub 2015 Apr 17.
PubMed 25891440

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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 Fixed-Dose Study of Vilazodone in Patients With Generalized Anxiety Disorder.
ClinicalTrials.gov ID: NCT01629966
Acronym / sponsor ID: VLZ-MD-05 / VLZ-MD-05
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder, GAD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 680 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: 30 Jun 2012 (actual)
Primary completion: 28 Feb 2014 (actual)
Study completion: 31 Mar 2014 (actual)
First posted: 28 Jun 2012 (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: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboDose-matched placebo one per day, oral administration
Vilazadone 20mg	Experimental	Drug: VilazodoneVilazodone 20mg once per day, oral administration.
Vilazodone 40mg	Experimental	Drug: VilazodoneVilazodone 40mg once per day, 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 and female, 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 (GAD)
Minimum score of 20 on the Hamilton Rating Scale for Anxiety (HAM-A)

Key exclusion criteria (11 listed)

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
History of meeting DSM-IV-TR criteria for any of the following:
Patients who are considered a suicide risk

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
PlaceboMatching 10 mg and 20 mg placebo tablets, once per day, oral administration,	Drug	Placebo
VilazodoneVilazodone, 20mg, oral administration once per day.	Drug	Vilazadone 20mg
VilazodoneVilazodone, 40mg, oral administration once per day.	Drug	Vilazodone 40mg

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

Results posted to the registry on 18 Dec 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	221	180
Vilazadone 20mg	227	175
Vilazodone 40mg	225	159

Primary outcome: Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

Time frame: Baseline to Week 8. Mean (Standard Deviation). Unit: Score on scale

Measure	Placebo n = 221	Vilazadone 20mg n = 223	Vilazodone 40mg n = 223
Value	13.1 (7.93)	12.0 (7.13)	11.2 (7.46)

Placebo vs Vilazadone 20mg: Least Squares Mean Difference: -1.27 (95% CI -2.71 to 0.17), p = 0.0830, MMRM
Placebo vs Vilazodone 40mg: Least Squares Mean Difference: -1.80 (95% CI -3.26 to -0.34), p = 0.0156, MMRM

Population analysed: The Intent-to-Treat (ITT) Population consisted of all patients in the Safety Population who had at least 1 postbaseline assessment of HAM-A.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were collected until week 8.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 221 (0.5%)	85 of 221 (38.5%)	0 of 221
Vilazadone 20mg	1 of 227 (0.4%)	123 of 227 (54.2%)	0 of 227
Vilazodone 40mg	0 of 225 (0%)	121 of 225 (53.8%)	0 of 225

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 25891440Gommoll C, Durgam S, Mathews M, Forero G, Nunez R, Tang X, Thase ME. A double-blind, randomized, placebo-controlled, fixed-dose phase III study of vilazodone in patients with generalized anxiety disorder. Depress Anxiety. 2015 Jun;32(6):451-9. doi: 10.1002/da.22365. Epub 2015 Apr 17.

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RecruitingObservational study
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Active, not recruitingObservational study
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RecruitingPhase 2
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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 Laboratories

37 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 37 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 11 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 37 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 NCT01629966, 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; AzTrials last refreshed its copy on 8 Nov 2026.