NCT01712321

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 20, 2014

Status Verified

January 1, 2014

Enrollment Period

1.4 years

First QC Date

October 18, 2012

Last Update Submit

January 16, 2014

Conditions

Social Anxiety Disorder

Keywords

Social Anxiety DisorderSocial AnxietySocial PhobiaSAD

Outcome Measures

Primary Outcomes (1)

  • Change in Liebowitz Social Anxiety Scale (LSAS) - total score

    All subjects randomized to drug or placebo and returning for at least one subsequent visit will be included in the primary efficacy analyses.

    Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks

Secondary Outcomes (6)

  • Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2

    Study Endpoint: minimum 6 weeks - maximum 12 weeks

  • Change in the Clinical Global Impression of Severity of Illness score

    Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks

  • Change on the LSAS anxiety and avoidance subscales

    Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks

  • Change in Hamilton Depression scale total

    Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks

  • Change in Hamilton Anxiety scale total

    Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Vilazodone

EXPERIMENTAL

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

Drug: Vilazodone

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

VilazodoneDRUG

Vilazodone 20mg or 40mg taken once daily by mouth

Also known as: Viibryd
Vilazodone
PlaceboDRUG

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

Also known as: Matching placebo
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Lifetime history of Bipolar disorder or Schizophrenia
  • Current suicidal risk
  • Current unstable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Medical Research Network, LLC

New York, New York, 10128, United States

Location

Related Publications (1)

  • 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.

    PMID: 27057414DERIVED

MeSH Terms

Conditions

Phobia, Social

Interventions

Vilazodone Hydrochloride

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndoles

Study Officials

  • Michael R. Liebowitz, MD

    The Medical Research Network, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2012

First Posted

October 23, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2014

Study Completion

April 1, 2014

Last Updated

January 20, 2014

Record last verified: 2014-01

Locations

US(1)