Study of Vilazodone to Treat Social Anxiety Disorder

NCT ID: NCT01712321

Last Updated: 2014-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The proposed study is a 12 week double-blind, placebo-controlled trial in which daily doses of vilazodone 20 to 40 mg/day or matching placebo will be administered on a 1:1 ratio. The study will include 30 outpatients age 18-75 with SAD, generalized subtype who return for at least one post randomization visit where efficacy evaluations are conducted.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Social Anxiety Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vilazodone

Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks

Group Type EXPERIMENTAL

Vilazodone

Intervention Type DRUG

Vilazodone 20mg or 40mg taken once daily by mouth

Placebo

Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vilazodone

Vilazodone 20mg or 40mg taken once daily by mouth

Intervention Type DRUG

Placebo

Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Viibryd Matching placebo

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of Social Anxiety Disorder, generalized subtype
* LSAS total score of 70 at visits 1 and 2

Exclusion Criteria

* Lifetime history of Bipolar disorder or Schizophrenia
* Current suicidal risk
* Current unstable medical condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Forest Laboratories

INDUSTRY

Sponsor Role collaborator

The Medical Research Network

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael R. Liebowitz, MD

Role: PRINCIPAL_INVESTIGATOR

The Medical Research Network, LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Medical Research Network, LLC

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Careri JM, Draine AE, Hanover R, Liebowitz MR. A 12-Week Double-Blind, Placebo-Controlled, Flexible-Dose Trial of Vilazodone in Generalized Social Anxiety Disorder. Prim Care Companion CNS Disord. 2015 Nov 26;17(6):10.4088/PCC.15m01831. doi: 10.4088/PCC.15m01831. eCollection 2015.

Reference Type DERIVED
PMID: 27057414 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VII-IT-07

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Quetiapine in Social Anxiety Disorder
NCT00215254 COMPLETED PHASE2/PHASE3