Social Anxiety Disorder
Conditions
Keywords
Social Anxiety Disorder, Social Phobia, SAD
Brief summary
This study is designed to evaluate the efficacy and safety of Pristiq® in treatment of the symptoms of Generalized Social Anxiety Disorder (SAD).
Detailed description
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.
Interventions
DRUGPristiq
Flexible dose, 50-100mg QD, for 12 weeks.
DRUGPlacebo
Matching placebo, taken QD for 12 weeks.
Sponsors
Pfizer
The Medical Research Network
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must give written informed consent prior to any study procedures. * Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder, Generalized Subtype) according to DSM-IV-TR criteria, as determined by psychiatric evaluation with the Principal Investigator. * A minimum score of 60 on the LSAS total score at both Screening and Baseline visits. * A total HAM-D score of less than 15 at the Screening visit. * CGI Severity score of 4 or greater at both Screening and Baseline visits. * Female subjects of childbearing potential must commit to an effective form of contraception for the duration of the trial. Effective forms of contraception include: condoms with spermicide, diaphragm with spermicide, hormonal contraceptive agents (oral, transdermal, or injectable), and implantable contraceptive devices.
Exclusion criteria
* An Axis I disorder other than SAD (e.g., post-traumatic stress disorder, obsessive compulsive disorder, panic disorder) within 24 weeks of the Baseline visit. Subjects with co-morbid MDD, GAD, dysthymia, or specific phobias will be allowed if GSAD is the primary disorder in terms of clinical severity, as determined by the investigator. * Any history or complication of schizophrenia or bipolar disorder. * Any complication of body dysmorphic disorder. * Substance dependence, as defined by DSM-IV-TR criteria, within 24 weeks of the Baseline visit. * Subjects who are currently pregnant, lactating, or of childbearing potential and not practicing an effective method of contraception. * Subjects scoring \>2 on item #3 of the HAM-D, or who, in the opinion of the PI, are at a clinically significant risk for suicide. * Systolic blood pressure ≥165 and/or diastolic blood pressure ≥95. * Positive Urine Drug Screen at the Screening visit. * Any current unstable and/or clinically significant medical condition, based on history or as evidenced in Screening laboratory and ECG assessments. * Any history or complication of cancer or malignant tumor. * Fluoxetine within 28 days of Baseline * MAO inhibitors within 14 days of Baseline - Any other psychotropics (including SSRIs, SNRIs, and benzodiazepines) within 14 days of Baseline. Zolpidem (Ambien®) PRN is allowed for insomnia if not taken more than 3 times per week. * Subjects who started psychotherapy or cognitive-behavioral therapy within 24 weeks of the Baseline visit, except for supportive psychotherapy. * Electro-convulsive therapy (ECT) within 12 weeks of the Baseline visit. * Treatment refractory GSAD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Baseline to study endpoint (Week 12) | Liebowitz Social Anxiety Scale, measuring social anxiety symptoms; possible total scores ranging from 0-144, with higher scores indicating greater severity of symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Global Impression of Improvement Scale (CGI-I) | Baseline to Week 12 | 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. |
| Patient Global Impression of Change | Baseline to study endpoint (Week 12) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pristiq Flexible dose, 50-100mg QD
Pristiq: Flexible dose, 50-100mg QD, for 12 weeks. | 30 |
| Placebo Matching placebo
Placebo: Matching placebo, taken QD for 12 weeks. | 33 |
| Total | 63 |
Baseline characteristics
| Characteristic | Pristiq | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 33 Participants | 63 Participants |
| Age, Continuous | 39.9 years STANDARD_DEVIATION 14.6 | 41.9 years STANDARD_DEVIATION 13.7 | 40.0 years STANDARD_DEVIATION 19.9 |
| Region of Enrollment United States | 30 participants | 33 participants | 63 participants |
| Sex: Female, Male Female | 16 Participants | 13 Participants | 29 Participants |
| Sex: Female, Male Male | 14 Participants | 20 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 30 | 25 / 33 |
| serious Total, serious adverse events | 0 / 30 | 0 / 33 |
Outcome results
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.
Time frame: Baseline to study endpoint (Week 12)
Population: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pristiq | Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Mean baseline LSAS total | 93.4 Scores on a scale | Standard Deviation 17.1 |
| Pristiq | Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Endpoint LSAS total | 55.0 Scores on a scale | Standard Deviation 27.4 |
| Pristiq | Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Mean LSAS change from baseline | 38.4 Scores on a scale | Standard Deviation 28.8 |
| Placebo | Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Mean baseline LSAS total | 92.1 Scores on a scale | Standard Deviation 16.8 |
| Placebo | Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Endpoint LSAS total | 63.4 Scores on a scale | Standard Deviation 22.1 |
| Placebo | Change in the Liebowitz Social Anxiety Scale (LSAS) Total Score | Mean LSAS change from baseline | 28.7 Scores on a scale | Standard Deviation 24.2 |
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.
Time frame: Baseline to Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pristiq | Clinical Global Impression of Improvement Scale (CGI-I) | 69 % of subjects who were CGI-I responders |
| Placebo | Clinical Global Impression of Improvement Scale (CGI-I) | 48.3 % of subjects who were CGI-I responders |
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.
Time frame: Baseline to study endpoint (Week 12)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pristiq | Patient Global Impression of Change | 44.8 percentage of self-rated responders |
| Placebo | Patient Global Impression of Change | 40.7 percentage of self-rated responders |