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| ID | Type | Description | Link |
|---|---|---|---|
| WS1228302 | Other Grant/Funding Number | Pfizer, Inc. |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).
Social Anxiety Disorder (SAD) is recognized as a prevalent, chronic and disabling condition. Lifetime prevalence has been estimated at 13% in the National Comorbidity Survey. There is good reason to think that Pristiq® would be effective in Social Anxiety Disorder. Effexor XR, which is mechanistically similar to Pristiq®, was found effective for subjects with Generalized Social Anxiety Disorder in all five of the placebo controlled trials in which it was studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pristiq | Experimental | Flexible dose, 50-100mg QD |
|
| Placebo | Placebo Comparator | Matching placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pristiq | Drug | Flexible dose, 50-100mg QD, for 12 weeks. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms. | Baseline to study endpoint (Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impression of Improvement Scale (CGI-I) | CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint. | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael R. Liebowitz, MD | The Medical Research Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medical Research Network, LLC | New York | New York | 10128 | United States |
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| Label | URL |
|---|---|
| Click here for more information about The Medical Research Network. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pristiq | Flexible dose, 50-100mg QD Pristiq: Flexible dose, 50-100mg QD, for 12 weeks. |
| FG001 | Placebo | Matching placebo Placebo: Matching placebo, taken QD for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pristiq | Flexible dose, 50-100mg QD Pristiq: Flexible dose, 50-100mg QD, for 12 weeks. |
| BG001 | Placebo | Matching placebo Placebo: Matching placebo, taken QD for 12 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms. | The number of participants for analysis was 29 subjects per arm; data analyzed at Week 12 or Last Observation Carried Forward for the 16 subjects who dropped out before completion. Five other randomized subjects (1 on drug, 4 on placebo) were excluded from the ITT sample because of insufficient data (n = 4) or poor compliance (n = 1). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline to study endpoint (Week 12) |
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pristiq | Flexible dose, 50-100mg QD Pristiq: Flexible dose, 50-100mg QD, for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness/lightheadedness/feeling faint | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael R. Liebowitz, M.D. | The Medical Research Network, LLC | (212) 595-5012 | MLiebowitz@MedicalResearchNetwork.com |
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| ID | Term |
|---|---|
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D010698 | Phobic Disorders |
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069468 | Desvenlafaxine Succinate |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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| Placebo | Drug | Matching placebo, taken QD for 12 weeks. |
|
| Patient Global Impression of Change |
Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders. |
| Baseline to study endpoint (Week 12) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Placebo |
Matching placebo Placebo: Matching placebo, taken QD for 12 weeks. |
|
|
| Secondary | Clinical Global Impression of Improvement Scale (CGI-I) | CGI-I: one item, measuring overall improvement of illness; possible scores range from 1-7, with lower scores representing greater improvement. CGI-I responders: defined as having a CGI-I scores of 1 or 2 at Week 12/study endpoint. | Posted | Number | % of subjects who were CGI-I responders | Baseline to Week 12 |
|
|
|
| Secondary | Patient Global Impression of Change | Subject-rated global outcome scale. Subjects who rated themselves as 1 (Very Much Improved) or 2 (Much Improved) on the PGIC were considered self-rated responders. | Posted | Number | percentage of self-rated responders | Baseline to study endpoint (Week 12) |
|
|
|
| 0 |
| 30 |
| 26 |
| 30 |
| EG001 | Placebo | Matching placebo Placebo: Matching placebo, taken QD for 12 weeks. | 0 | 33 | 25 | 33 |
| nausea/queasiness | General disorders | Systematic Assessment |
|
| drowsiness | General disorders | Systematic Assessment |
|
| insomnia | Nervous system disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
| fatigue | General disorders | Systematic Assessment |
|
| decreased appetite | General disorders | Systematic Assessment |
|
| indigestion | Gastrointestinal disorders | Systematic Assessment |
|
| flu/flu symptoms | General disorders | Systematic Assessment |
|
| soft stools/diarrhea | General disorders | Systematic Assessment |
|
| dry mouth | General disorders | Systematic Assessment |
|
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| Organic Chemicals |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D008055 | Lipids |