Social Anxiety DisorderNCT01712321
Study of Vilazodone to Treat Social Anxiety Disorder
A study testing Vilazodone in people with Social Anxiety Disorder, run by The Medical Research Network at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Social 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Social Anxiety Disorder, generalized subtype
- LSAS total score of 70 at visits 1 and 2
Who cannot join
- Lifetime history of Bipolar disorder or Schizophrenia
- Current suicidal risk
- Current unstable medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical Research Network, LLC
New York, New York, 10128
About this study
Official title: Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study
The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.
Read the detailed description
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
- Social Anxiety Disorder
- Being tested
- Vilazodone, Placebo
- Keywords
- Social Anxiety Disorder, Social Anxiety, Social Phobia, SAD
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VilazodoneDrug
Also called Viibryd
Vilazodone 20mg or 40mg taken once daily by mouth
PlaceboDrug
Also called Matching placebo
Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth
| Study group | Role | What they receive |
|---|---|---|
| Vilazodone | Experimental | Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks Receives: Drug: Vilazodone |
| Placebo | Placebo comparator | Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Responder rate as defined by a CGI Improvement score of 1 (Very Much Improved) or 2 (Much Improved) at study endpoint.
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
Measured: Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in the Clinical Global Impression of Severity of Illness score
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
Measured: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change on the LSAS anxiety and avoidance subscales
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
Measured: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in Hamilton Depression scale total
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
Measured: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in Hamilton Anxiety scale total
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
Measured: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Subject-assessed responder rate
Subject-assessed responder rate, as defined by a Patient Global Impression of Change score of 1 (Very Much Improved) or 2 (Much Improved) at study endpoint.
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
Measured: Study Endpoint: minimum 6 weeks - maximum 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Social 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Medical Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor
- Investigators
- Michael R. Liebowitz, MD, Principal investigator, The Medical Research Network, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712321
- Sponsor's protocol ID
- VII-IT-07
- Status last verified
- Jan 2014
- First submitted
- 18 Oct 2012
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27057414
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study
- ClinicalTrials.gov ID
- NCT01712321
- Acronym / sponsor ID
- VII-IT-07
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety Disorder, Social Anxiety, Social Phobia, SAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Medical Research NetworkUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
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 determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.
Detailed description
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.
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 |
|---|---|---|
| Vilazodone | Experimental | Drug: VilazodoneVilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Social Anxiety Disorder, generalized subtype
- LSAS total score of 70 at visits 1 and 2
Key exclusion criteria (3 listed)
- Lifetime history of Bipolar disorder or Schizophrenia
- Current suicidal risk
- Current unstable medical condition
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 |
|---|---|---|
| VilazodoneAlso: ViibrydVilazodone 20mg or 40mg taken once daily by mouth | Drug | Vilazodone |
| PlaceboAlso: Matching placeboPlacebo matching Vilazodone 20mg or 40mg, taken once daily by mouth | Drug | Placebo |
Primary outcome
Change in Liebowitz Social Anxiety Scale (LSAS) - total score
Time frame: Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks
All subjects randomized to drug or placebo and returning for at least one subsequent visit will be included in the primary efficacy analyses.
6 secondary outcomes
Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2
Time frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in the Clinical Global Impression of Severity of Illness score
Time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change on the LSAS anxiety and avoidance subscales
Time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in Hamilton Depression scale total
Time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in Hamilton Anxiety scale total
Time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Subject-assessed responder rate
Time frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
- Derived from this study: PubMed 27057414Careri 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.
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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.
Michael R. Liebowitz, MD principal investigator
The Medical Research Network, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vilazodone in people with Social Anxiety Disorder, run by The Medical Research Network at 1 site 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Results are not available in the source record.
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 Liebowitz Social Anxiety Scale (LSAS) - total score (time frame: Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks). 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 NCT01712321, which also lists 1 linked publication.
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 20 Jan 2014.