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| ID | Type | Description | Link |
|---|---|---|---|
| R01MH064481 | U.S. NIH Grant/Contract | View source | |
| DSIR 83-ATAS | |||
| R01MH064726 | U.S. NIH Grant/Contract | View source | |
| GSK ID: 101618 | Other Identifier | GlaxoSmithKline |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine Continuation | Experimental | Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. |
|
| Paroxetine with CBT Augmentation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug | Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change measured from Week 12 to Week 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Heimberg, PhD | Adult Anxiety Clinic of Temple University | Principal Investigator |
| Michael Liebowitz, MD | New York State Psychiatric Institute Anxiety Disorders Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute Anxiety Disorders Clinic | New York | New York | 10032 | United States | ||
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Among the 150 patients enrolled in Phase I, a total of 61 patients began Phase II These patients were classified as partial responders at week 12 (LSAS>29 but at least 10% improvement in LSAS score), and were therefore randomized to receive 16 weeks of continued treatment with paroxetine with or without CBT.
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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Paroxetine Continuation | Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. |
| FG001 | Paroxetine With CBT Augmentation | 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. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients included here were the subset of enrollees completing the open trial as partial responders.
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| ID | Title | Description |
|---|---|---|
| BG000 | Paroxetine Continuation | Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. |
| BG001 |
| 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 | 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. | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | Posted | Mean | Standard Deviation | units on a scale | Change measured from Week 12 to Week 28 |
|
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).
The pharmacotherapist used a checklist to inquire about the presence of 29 potential adverse effects at each visit and rated the severity of each on a scale from 0 to 3 (none, mild, moderate, or severe). Any event with a rating greater than 0 reported at any of the visits listed above is included here.
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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 | Paroxetine Continuation | Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heavy menstrual bleeding | Reproductive system and breast disorders | Systematic Assessment | 24 year old female reported heavy menstrual bleeding. It was determined that the bleeding was likely related to polycystic ovarian syndrome. Bleeding returned to normal levels after initiation of hormone treatment. SAE unrelated to study meds. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | General disorders | Systematic Assessment |
Limitations include the small size of the randomized sample and the lack of a placebo arm in the randomization phase of the study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard G. Heimberg, Ph.D. | Temple University | 215.204.7489 | heimberg@temple.edu |
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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 |
|---|---|
| D017374 | Paroxetine |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001521 | Behavior Therapy |
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Open trial of paroxetine (Phase 1) followed by randomization to either continued paroxetine or continued paroxetine plus cognitive behavioral therapy (Phase 2) for patients showing partial response to paroxetine in Phase 1.
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Independent evaluators were unaware of randomized condition in the augmentation phase (Phase 2).
|
| Cognitive behavioral therapy (CBT) | Behavioral | CBT will consist of 16 weekly treatment sessions. |
|
| 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. | 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. | 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. | 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. | 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. | Change measured from Week 12 to Week 28 |
| Adult Anxiety Clinic of Temple University |
| Philadelphia |
| Pennsylvania |
| 19122-6085 |
| United States |
| Paroxetine With CBT Augmentation |
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. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Liebowitz Social Anxiety Scale | The Liebowitz Social Anxiety Scale 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. | Mean | Standard Deviation | units on a scale |
|
| Social Interaction Anxiety Scale | The Social Interaction Anxiety Scale 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. | Mean | Standard Deviation | units on a scale |
|
| Social Phobia Scale | The Social Phobia Scale 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. | Mean | Standard Deviation | units on a scale |
|
| Brief Fear of Negative Evaluation Scale | The Brief Fear of Negative Evaluation Scale 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. | Mean | Standard Deviation | units on a scale |
|
| Liebowitz Self-Rated Disability Scale | The Liebowitz Self-Report Disability Scale 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. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life Inventory | The Quality of Life Inventory 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. Higher scores represent a higher quality of life. | Mean | Standard Deviation | units on a scale |
|
Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. |
| OG001 | Paroxetine With CBT Augmentation | 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. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions. |
|
|
|
| Secondary | 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. | Responders (CGI-I=1 or 2). Remitters (CGI-I=1). Analyses based on Week 28 observations if available. if not, Week 20 or Week 12 observations were substituted. Fisher's Exact Test used for analyses. | Posted | Count of Participants | Participants | Responder and remitter status measured at Week 28 |
|
|
|
|
| Secondary | 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. | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | Posted | Mean | Standard Deviation | units on a scale | Change measured from Week 12 to Week 28 |
|
|
|
|
| Secondary | 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. | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | Posted | Mean | Standard Deviation | units on a scale | Change measured from Week 12 to Week 28 |
|
|
|
|
| Secondary | 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. | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | Posted | Mean | Standard Deviation | units on a scale | Change measured from Week 12 to Week 28 |
|
|
|
|
| Secondary | 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. | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | Posted | Mean | Standard Deviation | units on a scale | Change measured from Week 12 to Week 28 |
|
|
|
|
| Secondary | 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. | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | Posted | Mean | Standard Deviation | units on a scale | Change measured from Week 12 to Week 28 |
|
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| 29 |
| 29 |
| EG001 | Paroxetine With CBT Augmentation | 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. Paroxetine: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. Cognitive behavioral therapy (CBT): CBT will consist of 16 weekly treatment sessions. | 0 | 32 | 0 | 32 | 29 | 32 |
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| Palpitations | General disorders | Systematic Assessment |
|
| Myalgia | General disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
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| Sweating | General disorders | Systematic Assessment |
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| Photophobia | General disorders | Systematic Assessment |
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| Tachycardia | General disorders | Systematic Assessment |
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| Bradycardia | General disorders | Systematic Assessment |
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| Constipation | General disorders | Systematic Assessment |
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| Diarrhea | General disorders | Systematic Assessment |
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| Lightheadedness | General disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
|
| Blurry Vision | General disorders | Systematic Assessment |
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| Parathesias | General disorders | Systematic Assessment |
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| Decreased Libido | General disorders | Systematic Assessment |
|
| Anorgasmia | General disorders | Systematic Assessment |
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| Impaired Coordination | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
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| Nervousness | General disorders | Systematic Assessment |
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| Insomnia | General disorders | Systematic Assessment |
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| Tremor | General disorders | Systematic Assessment |
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| Weight Gain | General disorders | Systematic Assessment |
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| Weight Loss | General disorders | Systematic Assessment |
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| Dermatitis | General disorders | Systematic Assessment |
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| Urinary Congestion | General disorders | Systematic Assessment |
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| Nasal Congestion | General disorders | Systematic Assessment |
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| Rigidity | General disorders | Systematic Assessment |
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| Somnolence | General disorders | Systematic Assessment |
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| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| Remitter Status |
|
| Fisher Exact |
| .034 |
Fisher's Exact Test used for analyses. |
| Superiority |