Trial Outcomes & Findings for Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder (NCT NCT00074802)
NCT ID: NCT00074802
Last Updated: 2017-06-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
Change measured from Week 12 to Week 28
Results posted on
2017-06-14
Participant Flow
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).
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
32
|
|
Overall Study
COMPLETED
|
20
|
25
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Paroxetine Continuation
n=29 Participants
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.
|
Paroxetine With CBT Augmentation
n=32 Participants
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.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.38 years
STANDARD_DEVIATION 12.30 • n=39 Participants
|
32.22 years
STANDARD_DEVIATION 9.73 • n=41 Participants
|
33.72 years
STANDARD_DEVIATION 11.05 • n=35 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=39 Participants
|
24 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
54 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
28 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Liebowitz Social Anxiety Scale
|
49.45 units on a scale
STANDARD_DEVIATION 19.23 • n=39 Participants
|
44.63 units on a scale
STANDARD_DEVIATION 13.60 • n=41 Participants
|
46.92 units on a scale
STANDARD_DEVIATION 16.55 • n=35 Participants
|
|
Social Interaction Anxiety Scale
|
39.30 units on a scale
STANDARD_DEVIATION 11.08 • n=39 Participants
|
35.43 units on a scale
STANDARD_DEVIATION 12.35 • n=41 Participants
|
37.19 units on a scale
STANDARD_DEVIATION 11.85 • n=35 Participants
|
|
Social Phobia Scale
|
20.04 units on a scale
STANDARD_DEVIATION 11.87 • n=39 Participants
|
17.43 units on a scale
STANDARD_DEVIATION 10.85 • n=41 Participants
|
18.62 units on a scale
STANDARD_DEVIATION 11.29 • n=35 Participants
|
|
Brief Fear of Negative Evaluation Scale
|
26.20 units on a scale
STANDARD_DEVIATION 7.34 • n=39 Participants
|
21.83 units on a scale
STANDARD_DEVIATION 6.41 • n=41 Participants
|
23.82 units on a scale
STANDARD_DEVIATION 7.13 • n=35 Participants
|
|
Liebowitz Self-Rated Disability Scale
|
8.42 units on a scale
STANDARD_DEVIATION 4.56 • n=39 Participants
|
6.58 units on a scale
STANDARD_DEVIATION 4.40 • n=41 Participants
|
7.42 units on a scale
STANDARD_DEVIATION 4.52 • n=35 Participants
|
|
Quality of Life Inventory
|
0.67 units on a scale
STANDARD_DEVIATION 1.65 • n=39 Participants
|
0.31 units on a scale
STANDARD_DEVIATION 1.67 • n=41 Participants
|
0.48 units on a scale
STANDARD_DEVIATION 1.66 • n=35 Participants
|
PRIMARY outcome
Timeframe: Change measured from Week 12 to Week 28Population: 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.
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.
Outcome measures
| Measure |
Paroxetine Continuation
n=29 Participants
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.
|
Paroxetine With CBT Augmentation
n=32 Participants
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.
|
|---|---|---|
|
Liebowitz Social Anxiety Scale (LSAS)
|
7.77 units on a scale
Standard Deviation 22.49
|
7.84 units on a scale
Standard Deviation 17.15
|
SECONDARY outcome
Timeframe: Responder and remitter status measured at Week 28Population: 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.
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.
Outcome measures
| Measure |
Paroxetine Continuation
n=29 Participants
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.
|
Paroxetine With CBT Augmentation
n=32 Participants
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.
|
|---|---|---|
|
Clinical Global Impression Improvement Scale (CGI-I)
Remitter Status · Responder
|
3 Participants
|
11 Participants
|
|
Clinical Global Impression Improvement Scale (CGI-I)
Responder Status · Responder
|
17 Participants
|
28 Participants
|
|
Clinical Global Impression Improvement Scale (CGI-I)
Responder Status · Non-Responder
|
12 Participants
|
4 Participants
|
|
Clinical Global Impression Improvement Scale (CGI-I)
Remitter Status · Non-Responder
|
26 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Change measured from Week 12 to Week 28Population: 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.
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.
Outcome measures
| Measure |
Paroxetine Continuation
n=29 Participants
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.
|
Paroxetine With CBT Augmentation
n=32 Participants
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.
|
|---|---|---|
|
Social Interaction Anxiety Scale (SIAS)
|
3.43 units on a scale
Standard Deviation 9.58
|
5.67 units on a scale
Standard Deviation 11.55
|
SECONDARY outcome
Timeframe: Change measured from Week 12 to Week 28Population: 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.
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.
Outcome measures
| Measure |
Paroxetine Continuation
n=29 Participants
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.
|
Paroxetine With CBT Augmentation
n=32 Participants
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.
|
|---|---|---|
|
Social Phobia Scale (SPS)
|
2.75 units on a scale
Standard Deviation 10.29
|
5.83 units on a scale
Standard Deviation 8.59
|
SECONDARY outcome
Timeframe: Change measured from Week 12 to Week 28Population: 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.
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.
Outcome measures
| Measure |
Paroxetine Continuation
n=29 Participants
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.
|
Paroxetine With CBT Augmentation
n=32 Participants
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.
|
|---|---|---|
|
Brief Fear of Negative Evaluation Scale (BFNE)
|
1.13 units on a scale
Standard Deviation 4.59
|
3.91 units on a scale
Standard Deviation 5.69
|
SECONDARY outcome
Timeframe: Change measured from Week 12 to Week 28Population: 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.
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.
Outcome measures
| Measure |
Paroxetine Continuation
n=29 Participants
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.
|
Paroxetine With CBT Augmentation
n=32 Participants
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.
|
|---|---|---|
|
Liebowitz Self-Report Disability Scale (LSRDS)
|
1.25 units on a scale
Standard Deviation 3.30
|
-0.02 units on a scale
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: Change measured from Week 12 to Week 28Population: 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.
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.
Outcome measures
| Measure |
Paroxetine Continuation
n=29 Participants
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.
|
Paroxetine With CBT Augmentation
n=32 Participants
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.
|
|---|---|---|
|
Quality of Life Inventory (QOLI)
|
0.25 units on a scale
Standard Deviation 1.24
|
-0.35 units on a scale
Standard Deviation 1.72
|
Adverse Events
Paroxetine Continuation
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Paroxetine With CBT Augmentation
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paroxetine Continuation
n=29 participants at risk
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.
|
Paroxetine With CBT Augmentation
n=32 participants at risk
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.
|
|---|---|---|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
3.4%
1/29 • Number of events 1 • 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.
|
0.00%
0/32 • 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.
|
Other adverse events
| Measure |
Paroxetine Continuation
n=29 participants at risk
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.
|
Paroxetine With CBT Augmentation
n=32 participants at risk
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.
|
|---|---|---|
|
General disorders
Headache
|
37.9%
11/29 • Number of events 25 • 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.
|
34.4%
11/32 • Number of events 23 • 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.
|
|
General disorders
Palpitations
|
34.5%
10/29 • Number of events 29 • 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.
|
15.6%
5/32 • Number of events 9 • 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.
|
|
General disorders
Myalgia
|
34.5%
10/29 • Number of events 20 • 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.
|
6.2%
2/32 • Number of events 6 • 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.
|
|
General disorders
Nausea
|
37.9%
11/29 • Number of events 16 • 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.
|
18.8%
6/32 • Number of events 10 • 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.
|
|
General disorders
Vomiting
|
13.8%
4/29 • Number of events 5 • 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.
|
12.5%
4/32 • Number of events 5 • 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.
|
|
General disorders
Sweating
|
41.4%
12/29 • Number of events 37 • 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.
|
12.5%
4/32 • Number of events 11 • 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.
|
|
General disorders
Photophobia
|
13.8%
4/29 • Number of events 15 • 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.
|
9.4%
3/32 • Number of events 11 • 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.
|
|
General disorders
Tachycardia
|
27.6%
8/29 • Number of events 24 • 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.
|
12.5%
4/32 • Number of events 6 • 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.
|
|
General disorders
Bradycardia
|
6.9%
2/29 • Number of events 8 • 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.
|
6.2%
2/32 • Number of events 2 • 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.
|
|
General disorders
Constipation
|
51.7%
15/29 • Number of events 38 • 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.
|
15.6%
5/32 • Number of events 9 • 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.
|
|
General disorders
Diarrhea
|
13.8%
4/29 • Number of events 14 • 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.
|
12.5%
4/32 • Number of events 6 • 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.
|
|
General disorders
Lightheadedness
|
51.7%
15/29 • Number of events 30 • 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.
|
28.1%
9/32 • Number of events 13 • 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.
|
|
General disorders
Dry Mouth
|
44.8%
13/29 • Number of events 24 • 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.
|
25.0%
8/32 • Number of events 16 • 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.
|
|
General disorders
Blurry Vision
|
13.8%
4/29 • Number of events 13 • 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.
|
6.2%
2/32 • Number of events 5 • 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.
|
|
General disorders
Parathesias
|
10.3%
3/29 • Number of events 5 • 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.
|
9.4%
3/32 • Number of events 4 • 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.
|
|
General disorders
Decreased Libido
|
55.2%
16/29 • Number of events 51 • 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.
|
56.2%
18/32 • Number of events 58 • 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.
|
|
General disorders
Anorgasmia
|
69.0%
20/29 • Number of events 73 • 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.
|
56.2%
18/32 • Number of events 65 • 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.
|
|
General disorders
Impaired Coordination
|
10.3%
3/29 • Number of events 5 • 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.
|
9.4%
3/32 • Number of events 7 • 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.
|
|
General disorders
Fatigue
|
48.3%
14/29 • Number of events 48 • 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.
|
46.9%
15/32 • Number of events 41 • 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.
|
|
General disorders
Nervousness
|
48.3%
14/29 • Number of events 32 • 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.
|
34.4%
11/32 • Number of events 30 • 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.
|
|
General disorders
Insomnia
|
34.5%
10/29 • Number of events 24 • 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.
|
28.1%
9/32 • Number of events 17 • 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.
|
|
General disorders
Tremor
|
17.2%
5/29 • Number of events 11 • 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.
|
21.9%
7/32 • Number of events 18 • 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.
|
|
General disorders
Weight Gain
|
65.5%
19/29 • Number of events 48 • 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.
|
56.2%
18/32 • Number of events 52 • 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.
|
|
General disorders
Weight Loss
|
17.2%
5/29 • Number of events 8 • 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.
|
21.9%
7/32 • Number of events 13 • 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.
|
|
General disorders
Dermatitis
|
20.7%
6/29 • Number of events 6 • 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.
|
12.5%
4/32 • Number of events 7 • 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.
|
|
General disorders
Urinary Congestion
|
20.7%
6/29 • Number of events 19 • 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.
|
18.8%
6/32 • Number of events 11 • 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.
|
|
General disorders
Nasal Congestion
|
24.1%
7/29 • Number of events 20 • 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.
|
28.1%
9/32 • Number of events 12 • 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.
|
|
General disorders
Rigidity
|
24.1%
7/29 • Number of events 19 • 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.
|
12.5%
4/32 • Number of events 4 • 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.
|
|
General disorders
Somnolence
|
55.2%
16/29 • Number of events 46 • 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.
|
53.1%
17/32 • Number of events 49 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place