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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vilazodone | Experimental | Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks |
|
| Placebo | Placebo Comparator | Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vilazodone | Drug | Vilazodone 20mg or 40mg taken once daily by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R. Liebowitz, MD | The Medical Research Network, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27057414 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 25, 2016 | |
| Reset | Oct 19, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 25, 2016 | Oct 19, 2016 |
| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069503 | Vilazodone Hydrochloride |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001572 | Benzofurans |
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| Placebo | Drug | Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth |
|
|
| 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. | 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. | 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. | 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. | 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. | Study Endpoint: minimum 6 weeks - maximum 12 weeks |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D007211 | Indoles |