A Phase 3 interventional study of Paroxetine and Cognitive behavioral therapy (CBT) in Social Anxiety Disorder, sponsored by Temple University. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-06-14.
Sponsored by Temple University · Phase 3, Interventional, and Treatment
This study will examine whether the addition of cognitive behavioral therapy can improve the efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder. Patients with social anxiety disorder will undergo a 12-week open trial with paroxetine. Those who complete the open trial having achieved only partial response will be randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to continue on paroxetine alone for an additional 16 weeks.
Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified. Paroxetine is effective in treating the acute symptoms of social anxiety, but many patients achieve less than optimal response. CBT has also been effective in treating social anxiety disorder; thus,it may also be effective in augmenting paroxetine response. This study will examine the effects of paroxetine treatment alone and in combination with CBT among patients who achieve less than optimal response after an open trial with paroxetine.
Participants in this study will receive paroxetine for 12 weeks (Phase 1). After 12 weeks, participants who have completed this open trial but have achieved some but less than optimal response will move forward to Phase 2. To be eligible to move forward to Phase 2, patients must have achieved at least a 10% improvement in their open-trial Liebowitz Social Anxiety Scale Scores (LSAS) but still have an LSAS score of 30 or greater. Patients meeting these criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. Social anxiety symptoms, rates of response and remission, fear of negative evaluation, disability and quality of life will be assessed.
4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.
This study's enrollment of 150 is above the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.
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Exclusion Criteria:
Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks.
Drug: Paroxetine
Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Drug: Paroxetine · Behavioral: Cognitive behavioral therapy (CBT)
Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day.
Also known as: Paxil
CBT will consist of 16 weekly treatment sessions.
Liebowitz Social Anxiety Scale (LSAS)
The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Time frame: Change measured from Week 12 to Week 28
Clinical Global Impression Improvement Scale (CGI-I)
The CGI-I is a 7-point clinician-administered scale measuring improvement in symptoms over time. Lower numbers represent greater improvement. We examined responder status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1 or 2) as well as remission status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1) as secondary outcomes.
Time frame: Responder and remitter status measured at Week 28
Social Interaction Anxiety Scale (SIAS)
The SIAS is a 20-item self-report measure of anxiety experienced while interacting in dyads or groups. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Time frame: Change measured from Week 12 to Week 28
Social Phobia Scale (SPS)
The SPS is a 20-item self-report measure of anxiety experienced when being observed by others. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Time frame: Change measured from Week 12 to Week 28
Brief Fear of Negative Evaluation Scale (BFNE)
The BFNE is a 12-item self-report measure of concern about negative evaluation by others. Items are rated on a 1-5 scale, yielding scores ranging from 12-60, with higher scores indicating greater fear of negative evaluation. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Time frame: Change measured from Week 12 to Week 28
Liebowitz Self-Report Disability Scale (LSRDS)
The LSRDS is an 11-item self-report measure of the degree to which one's emotional problems limit one's ability to function in a variety of domains. Items are rated on a 0-3 scale of severity, and 10 of the 11 items (choosing either school or work as one area and omitting the other) are summed to produce a total score, ranging from 0-30. Higher scores represent greater disability. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Time frame: Change measured from Week 12 to Week 28
Quality of Life Inventory (QOLI)
The QOLI is a 16-item self-report measure of life satisfaction. Each item is rated for importance (0-2) and satisfaction (-3 to +3), and these ratings are multiplied, summed, and divided by the number of non-zero entries to yield an average item score, which can range from -6 to +6. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
Time frame: Change measured from Week 12 to Week 28
Recruitment began in 2003 at the Adult Anxiety Clinic of Temple University and the Anxiety Disorders Clinic of the New York State Psychiatric Institute. 150 patients with Generalized Social Anxiety Disorder were enrolled in Phase I of the study (open treatment with the selective serotonin reuptake inhibitor paroxetine).
| Milestone | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Started | 29 | 32 |
| Completed | 20 | 25 |
| Not completed | 9 | 7 |
The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
| units on a scale | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Liebowitz Social Anxiety Scale (LSAS) | 7.77 ± 22.49 | 7.84 ± 17.15 |
The CGI-I is a 7-point clinician-administered scale measuring improvement in symptoms over time. Lower numbers represent greater improvement. We examined responder status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1 or 2) as well as remission status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1) as secondary outcomes.
| Participants | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Responder Status — Responder | 17 | 28 |
| Responder Status — Non-Responder | 12 | 4 |
| Remitter Status — Responder | 3 | 11 |
| Remitter Status — Non-Responder | 26 | 21 |
The SIAS is a 20-item self-report measure of anxiety experienced while interacting in dyads or groups. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
| units on a scale | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Social Interaction Anxiety Scale (SIAS) | 3.43 ± 9.58 | 5.67 ± 11.55 |
The SPS is a 20-item self-report measure of anxiety experienced when being observed by others. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
| units on a scale | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Social Phobia Scale (SPS) | 2.75 ± 10.29 | 5.83 ± 8.59 |
The BFNE is a 12-item self-report measure of concern about negative evaluation by others. Items are rated on a 1-5 scale, yielding scores ranging from 12-60, with higher scores indicating greater fear of negative evaluation. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
| units on a scale | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Brief Fear of Negative Evaluation Scale (BFNE) | 1.13 ± 4.59 | 3.91 ± 5.69 |
The LSRDS is an 11-item self-report measure of the degree to which one's emotional problems limit one's ability to function in a variety of domains. Items are rated on a 0-3 scale of severity, and 10 of the 11 items (choosing either school or work as one area and omitting the other) are summed to produce a total score, ranging from 0-30. Higher scores represent greater disability. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
| units on a scale | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Liebowitz Self-Report Disability Scale (LSRDS) | 1.25 ± 3.30 | -0.02 ± 2.72 |
The QOLI is a 16-item self-report measure of life satisfaction. Each item is rated for importance (0-2) and satisfaction (-3 to +3), and these ratings are multiplied, summed, and divided by the number of non-zero entries to yield an average item score, which can range from -6 to +6. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change.
| units on a scale | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Quality of Life Inventory (QOLI) | 0.25 ± 1.24 | -0.35 ± 1.72 |
Collected over Adverse events (AEs) were assessed from the beginning of the open trial phase of the study and throughout the randomized phase in which patients received paroxetine with or without CBT. Data presented in the Serious Adverse Events (SAE) and AE tables refer to events occurring during the randomized phase (Weeks 12, 16, 20, 24, and 28).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Paroxetine Continuation | 0/29 (0%) | 1/29 (3.4%) | 29/29 (100%) |
| Paroxetine With CBT Augmentation | 0/32 (0%) | 0/32 (0%) | 29/32 (90.6%) |
| Event | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| Heavy menstrual bleedingReproductive system and breast disorders | 1/29 | 0/32 |
| Event | Paroxetine Continuation | Paroxetine With CBT Augmentation |
|---|---|---|
| AnorgasmiaGeneral disorders | 20/29 | 18/32 |
| Weight GainGeneral disorders | 19/29 | 18/32 |
| Decreased LibidoGeneral disorders | 16/29 | 18/32 |
| SomnolenceGeneral disorders | 16/29 | 17/32 |
| ConstipationGeneral disorders | 15/29 | 5/32 |
| LightheadednessGeneral disorders | 15/29 | 9/32 |
| FatigueGeneral disorders | 14/29 | 15/32 |
| NervousnessGeneral disorders | 14/29 | 11/32 |
| Dry MouthGeneral disorders | 13/29 | 8/32 |
| SweatingGeneral disorders | 12/29 | 4/32 |
Patients included here were the subset of enrollees completing the open trial as partial responders.
| Age, Continuous(years) | Paroxetine Continuation | Paroxetine With CBT Augmentation | Total |
|---|---|---|---|
| Mean | 35.38 ± 12.30 | 32.22 ± 9.73 | 33.72 ± 11.05 |
| Sex: Female, Male(Participants) | Paroxetine Continuation | Paroxetine With CBT Augmentation | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 19 | 24 | 43 |
| Ethnicity (NIH/OMB)(Participants) | Paroxetine Continuation | Paroxetine With CBT Augmentation | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 4 | 7 |
| Not Hispanic or Latino | 26 | 28 | 54 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Paroxetine Continuation | Paroxetine With CBT Augmentation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 8 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 4 | 12 |
| White | 13 | 15 | 28 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 5 | 10 |
| Liebowitz Social Anxiety Scale(units on a scale) | Paroxetine Continuation | Paroxetine With CBT Augmentation | Total |
|---|---|---|---|
| Mean | 49.45 ± 19.23 | 44.63 ± 13.60 | 46.92 ± 16.55 |
| Social Interaction Anxiety Scale(units on a scale) | Paroxetine Continuation | Paroxetine With CBT Augmentation | Total |
|---|---|---|---|
| Mean | 39.30 ± 11.08 | 35.43 ± 12.35 | 37.19 ± 11.85 |
| Social Phobia Scale(units on a scale) | Paroxetine Continuation | Paroxetine With CBT Augmentation | Total |
|---|---|---|---|
| Mean | 20.04 ± 11.87 | 17.43 ± 10.85 | 18.62 ± 11.29 |
| Brief Fear of Negative Evaluation Scale(units on a scale) | Paroxetine Continuation | Paroxetine With CBT Augmentation | Total |
|---|---|---|---|
| Mean | 26.20 ± 7.34 | 21.83 ± 6.41 | 23.82 ± 7.13 |
2 further baseline measures are reported on the registry.
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