Trial Outcomes & Findings for Improving Treatment Outcomes in Pharmacotherapy of Generalized Social Anxiety Disorder (NCT NCT00282828)
NCT ID: NCT00282828
Last Updated: 2013-10-14
Results Overview
The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
397 participants
Primary outcome timeframe
Measured at Week 22 (Endpoint)
Results posted on
2013-10-14
Participant Flow
Recruitment for this study began in 2006 at the Massachusetts General Hospital, the University of California San Diego, and the Anxiety Disorders Clinic, McMaster University Medical Centre. Through approved recruitment methods, 397 patients with Generalized Social Anxiety Disorder (GSAD) were enrolled in Phase I of the study (open sertraline).
Among the 397 patients enrolled in Phase I of the study, 295 patients entered Phase II. A total of 181 (61%) of the patients who began Phase II were non-responders at week 10 (LSAS\>50), and were therefore randomized to receive 12 weeks of treatment in one of three treatment arms (sertraline plus clonazepam, venlafaxine, or sertraline plus placebo).
Participant milestones
| Measure |
Sertraline and Clonazepam
Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
|
Venlafaxine
Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
|
Sertraline and Placebo
Phase I non-responders randomized to this group received prolonged sertraline and placebo.
|
|---|---|---|---|
|
Overall Study
STARTED
|
63
|
59
|
59
|
|
Overall Study
COMPLETED
|
57
|
47
|
50
|
|
Overall Study
NOT COMPLETED
|
6
|
12
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Treatment Outcomes in Pharmacotherapy of Generalized Social Anxiety Disorder
Baseline characteristics by cohort
| Measure |
Sertraline and Clonazepam
n=63 Participants
Participants will take both sertraline and clonazepam
|
Venlafaxine
n=59 Participants
Participants will take venlafaxine only
|
Sertraline and Placebo
n=59 Participants
Participants will take both sertraline and placebo
|
Total
n=181 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
34.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
33.7 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
34.6 years
STANDARD_DEVIATION 12.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
115 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
34 participants
n=7 Participants
|
34 participants
n=5 Participants
|
105 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
26 participants
n=5 Participants
|
25 participants
n=7 Participants
|
25 participants
n=5 Participants
|
76 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Measured at Week 22 (Endpoint)Population: The present analysis was conducted in the modified ITT population (n=181), with remission based on week 22 LSAS for study completers (n=154, and last Phase II LSAS for the 27 patients who terminated early.
The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.
Outcome measures
| Measure |
Sertraline and Clonazepam
n=63 Participants
Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
|
Venlafaxine
n=59 Participants
Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
|
Sertraline and Placebo
n=59 Participants
Phase I non-responders randomized to this group received prolonged sertraline and placebo.
|
|---|---|---|---|
|
Rates of Remission (LSAS≤30) After 12 Weeks of Randomized Treatment During Phase II, Among Phase I Non-responders
|
17 participants
|
11 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Change from Week 10 to Week 22Population: This analysis was conducted in Phase I non-responders, randomized to receive 12 weeks of continued sertraline plus the addition of clonazepam, switch to venlafaxine, or prolonged sertraline plus placebo.
The Liebowitz Social Anxiety Scale (LSAS) is a 24-item scale assessing fear and avoidance in social and performance situations; it is widely used in studies of pharmacological treatment of Generalized Social Anxiety Disorder (GSAD). We analyzed the overall change in LSAS (last Phase II LSAS minus Week 10 LSAS). Higher numbers reflect greater drops in social anxiety disorder severity. Scores on the LSAS range from 0 to 144, with higher scores indicating greater pathology.
Outcome measures
| Measure |
Sertraline and Clonazepam
n=63 Participants
Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
|
Venlafaxine
n=59 Participants
Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
|
Sertraline and Placebo
n=59 Participants
Phase I non-responders randomized to this group received prolonged sertraline and placebo.
|
|---|---|---|---|
|
Post-treatment Social Phobia Severity as Defined by Endpoint LSAS Scores
|
27 units on a scale
Standard Deviation 24.4
|
18 units on a scale
Standard Deviation 19
|
16 units on a scale
Standard Deviation 23
|
Adverse Events
Sertraline and Clonazepam
Serious events: 3 serious events
Other events: 51 other events
Deaths: 0 deaths
Venlafaxine
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Sertraline and Placebo
Serious events: 0 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sertraline and Clonazepam
n=63 participants at risk
Participants will take both sertraline and clonazepam
|
Venlafaxine
n=59 participants at risk
Participants will take venlafaxine only
|
Sertraline and Placebo
n=59 participants at risk
Participants will take both sertraline and placebo
|
|---|---|---|---|
|
General disorders
Shortness of Breath
|
1.6%
1/63 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
0.00%
0/59 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
0.00%
0/59 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
Panic Attack
|
1.6%
1/63 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
0.00%
0/59 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
0.00%
0/59 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
Pacemaker inserted
|
1.6%
1/63 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
0.00%
0/59 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
0.00%
0/59 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
Other adverse events
| Measure |
Sertraline and Clonazepam
n=63 participants at risk
Participants will take both sertraline and clonazepam
|
Venlafaxine
n=59 participants at risk
Participants will take venlafaxine only
|
Sertraline and Placebo
n=59 participants at risk
Participants will take both sertraline and placebo
|
|---|---|---|---|
|
General disorders
ASTHENIA
|
17.5%
11/63 • Number of events 14 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
13.6%
8/59 • Number of events 10 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
25.4%
15/59 • Number of events 16 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
HEADACHE
|
19.0%
12/63 • Number of events 14 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
13.6%
8/59 • Number of events 11 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
25.4%
15/59 • Number of events 28 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
ANOREXIA
|
12.7%
8/63 • Number of events 9 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
18.6%
11/59 • Number of events 11 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
13.6%
8/59 • Number of events 9 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
DRY MOUTH
|
12.7%
8/63 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
20.3%
12/59 • Number of events 12 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
13.6%
8/59 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
INSOMNIA
|
12.7%
8/63 • Number of events 10 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
35.6%
21/59 • Number of events 27 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
42.4%
25/59 • Number of events 31 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
LIBIDO DECREASED
|
14.3%
9/63 • Number of events 9 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
10.2%
6/59 • Number of events 6 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
23.7%
14/59 • Number of events 15 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
SOMNOLENCE
|
31.7%
20/63 • Number of events 26 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
15.3%
9/59 • Number of events 11 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
23.7%
14/59 • Number of events 18 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
ABNORMAL DREAMS
|
9.5%
6/63 • Number of events 6 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
15.3%
9/59 • Number of events 9 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
18.6%
11/59 • Number of events 11 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
ABNORMAL EJACULATION
|
11.1%
7/63 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
10.2%
6/59 • Number of events 6 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
5.1%
3/59 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
AMNESIA
|
1.6%
1/63 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
5.1%
3/59 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
1.7%
1/59 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
ANXIETY
|
4.8%
3/63 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
1.7%
1/59 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
5.1%
3/59 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
CONSTIPATION
|
1.6%
1/63 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
10.2%
6/59 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
6.8%
4/59 • Number of events 5 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
COUGH INCREASED
|
3.2%
2/63 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
0.00%
0/59 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
5.1%
3/59 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
DEPRESSION
|
3.2%
2/63 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
6.8%
4/59 • Number of events 4 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
3.4%
2/59 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
DIARRHEA
|
11.1%
7/63 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
8.5%
5/59 • Number of events 5 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
18.6%
11/59 • Number of events 14 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
DIZZINESS
|
9.5%
6/63 • Number of events 6 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
11.9%
7/59 • Number of events 7 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
10.2%
6/59 • Number of events 6 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
DYSPEPSIA
|
4.8%
3/63 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
1.7%
1/59 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
8.5%
5/59 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
INCREASED APPETITE
|
3.2%
2/63 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
1.7%
1/59 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
6.8%
4/59 • Number of events 4 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
INFECTION
|
6.3%
4/63 • Number of events 5 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
8.5%
5/59 • Number of events 5 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
5.1%
3/59 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
NAUSEA
|
12.7%
8/63 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
11.9%
7/59 • Number of events 7 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
15.3%
9/59 • Number of events 11 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
NERVOUSNESS
|
6.3%
4/63 • Number of events 5 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
15.3%
9/59 • Number of events 11 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
16.9%
10/59 • Number of events 14 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
PAIN
|
3.2%
2/63 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
1.7%
1/59 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
8.5%
5/59 • Number of events 5 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
PHARYNGITIS
|
6.3%
4/63 • Number of events 4 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
5.1%
3/59 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
5.1%
3/59 • Number of events 4 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
RASH
|
1.6%
1/63 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
3.4%
2/59 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
5.1%
3/59 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
SEXUAL FUNCTION ABNORMAL
|
12.7%
8/63 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
10.2%
6/59 • Number of events 7 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
20.3%
12/59 • Number of events 14 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
SWEATING
|
1.6%
1/63 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
13.6%
8/59 • Number of events 8 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
16.9%
10/59 • Number of events 10 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
THINKING ABNORMAL
|
4.8%
3/63 • Number of events 3 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
3.4%
2/59 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
6.8%
4/59 • Number of events 4 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
TOOTH DISORDER
|
3.2%
2/63 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
8.5%
5/59 • Number of events 5 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
10.2%
6/59 • Number of events 7 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
TREMOR
|
9.5%
6/63 • Number of events 6 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
10.2%
6/59 • Number of events 6 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
3.4%
2/59 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
TWITCHING
|
1.6%
1/63 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
3.4%
2/59 • Number of events 2 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
6.8%
4/59 • Number of events 4 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
|
General disorders
URINARY FREQUENCY
|
0.00%
0/63 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
1.7%
1/59 • Number of events 1 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
6.8%
4/59 • Number of events 4 • Phase II, consisting of 12 weeks of randomized treatment.
Patients were asked about the occurrence of adverse events during each visit. These will be recorded by the clinician on the Adverse Events form and rated as mild, moderate or severe.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place