Generalized Anxiety DisorderPhase 3VLZ-MD-06NCT01766401

Safety, Efficacy and Tolerability of Vilazodone in Patients With Generalized Anxiety Disorder

A Phase 3 study testing Vilazadone in people with Generalized Anxiety Disorder, run by Forest Laboratories at 30 sites in United States.

Completed

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

Official record

Search all trials

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?: Vilazadone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 402 participants
Where: 30 sitesUnited States
Study dates: 31 Jan 2013to 29 Jan 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
Patients with a history of meeting DSM-IV-TR criteria for:
any manic, 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 cognitive disorders
Patients who are considered a suicide risk

Trial locations and contacts

30 sites in 1 country.

City, postcode or hospital

30 sites in 1 country

United States30 sites

Forest Investigative Site 014
Allentown, Pennsylvania, 18104
Forest Investigative Site 022
Arcadia, California, 91007
Forest Investigative Site 023
Beverly Hills, California, 90210
Forest Investigative Site 003
Canton, Ohio, 44718
Forest Investigative Site 031
Columbus, Ohio, 43210
Forest Investigative Site 017
Coral Springs, Florida, 33067
Forest Investigative Site 010
Encino, California, 91316
Forest Investigative Site 028
Fort Myers, Florida, 33912
Forest Investigative Site 008
Houston, Texas, 77054
Forest Investigative Site 018
Houston, Texas, 77096
Forest Investigative Site 026
Indianapolis, Indiana, 46260
Forest Investigative Site 002
Jacksonville, Florida, 32256
Forest Investigative Site 019
Las Vegas, Nevada, 89102
Forest Investigative Site 020
Leesburg, Florida, 34748
Forest Investigative Site 027
Lincoln, Rhode Island, 02865
Forest Investigative Site 021
Mason, Ohio, 45040
Forest Investigative Site 006
Memphis, Tennessee, 38119
Forest Investigative Site 024
Miami, Florida, 33015
Forest Investigative Site 011
Murray, Utah, 84123
Forest Investigative Site 025
Newport Beach, California, 92660
Forest Investigative Site 030
Oklahoma City, Oklahoma, 73112
Forest Investigative Site 001
Orlando, Florida, 32806
Forest Investigative Site 015
Philadelphia, Pennsylvania, 19139
Forest Investigative Site 004
Redlands, California, 92374
Forest Investigative Site 005
Salem, Oregon, 97301
Forest Investigative Site 007
Sherman Oaks, California, 91403
Forest Investigative Site 029
Shreveport, Louisiana, 71104
Forest Investigative Site 016
Temecula, California, 92562
Forest Investigative Site 012
Upland, California, 91786
Forest Investigative Site 013
Woodstock, Vermont, 05091

Other trials in United States

About this study

Official title: A Double-Blind, Placebo-Controlled, Flexible-Dose Study of Vilazadone 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, Vilazadone
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 Dose-matched placebo tablets, oral administration, once per day
VilazadoneDrug
Also called Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.
Viibryd

Study groups in NCT01766401
Study group	Role	What they receive
Placebo	Placebo comparator	Matching placebo tablets, oral administration Receives: Drug: Placebo
Vilazadone	Experimental	Vilazadone tablets, oral administration Receives: Drug: Vilazadone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
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.

31 Jan 201329 Jan 2014

First posted11 Jan 2013 (estimated)
Study start31 Jan 2013
Primary completion29 Jan 2014
Study completion29 Jan 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: 402 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01766401
Sponsor's protocol ID: VLZ-MD-06
Acronym: VLZ-MD-06
Status last verified: Nov 2019
First submitted: 9 Jan 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 27486544
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.
PubMed 26291335

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?

See locations

Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder

All Generalized Anxiety Disorder trials

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 Vilazadone in Patients With Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT01766401
Acronym / sponsor ID: VLZ-MD-06 / VLZ-MD-06
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder, GAD
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 402 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: 31 Jan 2013 (actual)
Primary completion: 29 Jan 2014 (actual)
Study completion: 29 Jan 2014 (actual)
First posted: 11 Jan 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: PlaceboMatching placebo tablets, oral administration
Vilazadone	Experimental	Drug: VilazadoneVilazadone 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 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
Patients with a history of meeting DSM-IV-TR criteria for:
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
PlaceboAlso: Dose-matched placebo tablets, oral administration, once per day	Drug	Placebo
VilazadoneAlso: Vilazadone once per day, 20 mg dose, oral administration or Vilazadone once per day, 40 mg dose, oral administration.Viibryd	Drug	Vilazadone

Primary outcome

Change in 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	198	161
Vilazadone	200	144

Primary outcome: Change in 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 = 197	Vilazadone n = 198
Value	14.9 (7.37)	13.5 (7.41)

Placebo vs Vilazadone: Least Squares Mean Difference: -1.50 (95% CI -2.96 to -0.04), p = 0.0438, 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 the 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	0 of 198 (0%)	75 of 198 (37.9%)	0 of 198
Vilazadone	0 of 200 (0%)	130 of 200 (65%)	0 of 200

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 26291335Gommoll 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.

Related trials for Generalized Anxiety Disorder

Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
Generalized Anxiety Disorder, Oxygenation Sensitive CMR
RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder
RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
Generalized Anxiety Disorder

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

30 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 Vilazadone in people with Generalized Anxiety Disorder, run by Forest Laboratories at 30 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 30 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 in 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 NCT01766401, 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.