Trial Outcomes & Findings for Anxiety and Recurrent Abdominal Pain in Children (NCT NCT00962039)
NCT ID: NCT00962039
Last Updated: 2020-06-11
Results Overview
Clinical Global Impression Scale - Improvement (CGI-I) is a 7-point scale, with lower values being more favorable, used to assess overall global illness improvement. The CGI is a clinician-completed measure, with values ranging from 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), to 7 (very much worse). CGI-I scores of 1 (very much improved) or 2 (much improved) were considered to indicate an acceptable treatment response. A global measure of functional status was chosen as a primary outcome due to the broad array of symptomatology seen in pediatric RAP and the ambiguous relationship between functional status and symptoms of pain, anxiety, and depression in pediatric RAP. The CGI-I is a dichotomous primary outcome measure of global clinical improvement with clinical response be defined as a CGI-I score of 1 or 2 for at least two consecutive weeks.
COMPLETED
PHASE2/PHASE3
81 participants
The CGI will be completed at weeks 2, 4, and 8
2020-06-11
Participant Flow
Subjects were clinically referred from primary care and specialty pediatric gastroenterology and were impaired as reflected by a score of less than 70 on the Children's Global Assessment Scale (CGAS).
Potential subjects with physical disease responsible for the abdominal pain, eating disorder, bipolar disorder, psychosis, alcohol/drug abuse, intellectual disability (IQ \< 70), pregnancy, or prior trial of SSRI antidepressant or venlafaxine were excluded.
Participant milestones
| Measure |
Citalopram
Citlaopram: Participants were randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects.
|
Placebo
Placebo: Participants were randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
35
|
37
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Anxiety and Recurrent Abdominal Pain in Children
Baseline characteristics by cohort
| Measure |
Citalopram
n=40 Participants
This double blind, placebo-controlled trial randomized 81 subjects ages 7 to 18 years in parallel groups to citalopram (n=40) or placebo (n=41) for 8 weeks. Citalopram was initiated at 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects. Subjects were recruited by clinical referral from both the primary care and specialty pediatric gastroenterology clinical settings. In addition to meeting criteria for FAP, subjects were required to be significantly impaired as reflected by a score of less than 70 on the Children's Global Assessment Scale (CGAS). Potential subjects with physical disease responsible for the observed abdominal pain, eating disorder, bipolar disorder, psychosis, alcohol/drug abuse, intellectual disability (IQ \< 70), pregnancy, or prior trial of SSRI antidepressant or venlafaxine were excluded.
|
Placebo
n=41 Participants
This double blind, placebo-controlled trial randomized 81 subjects ages 7 to 18 years in parallel groups to citalopram (n=40) or placebo (n=41) for 8 weeks. Citalopram was initiated at 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects. Subjects were recruited by clinical referral from both the primary care and specialty pediatric gastroenterology clinical settings. In addition to meeting criteria for FAP, subjects were required to be significantly impaired as reflected by a score of less than 70 on the Children's Global Assessment Scale (CGAS). Potential subjects with physical disease responsible for the observed abdominal pain, eating disorder, bipolar disorder, psychosis, alcohol/drug abuse, intellectual disability (IQ \< 70), pregnancy, or prior trial of SSRI antidepressant or venlafaxine were excluded.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
40 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: The CGI will be completed at weeks 2, 4, and 8Population: Analysis week 8
Clinical Global Impression Scale - Improvement (CGI-I) is a 7-point scale, with lower values being more favorable, used to assess overall global illness improvement. The CGI is a clinician-completed measure, with values ranging from 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), to 7 (very much worse). CGI-I scores of 1 (very much improved) or 2 (much improved) were considered to indicate an acceptable treatment response. A global measure of functional status was chosen as a primary outcome due to the broad array of symptomatology seen in pediatric RAP and the ambiguous relationship between functional status and symptoms of pain, anxiety, and depression in pediatric RAP. The CGI-I is a dichotomous primary outcome measure of global clinical improvement with clinical response be defined as a CGI-I score of 1 or 2 for at least two consecutive weeks.
Outcome measures
| Measure |
Citalopram
n=40 Participants
Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2).
Citalopram: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
Placebo
n=41 Participants
Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.
Placebo: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
|---|---|---|
|
Clinical Global Impression Scale - Improvement (CGI-I) Will be Used to Assess Overall Global Illness Improvement. CGI-I Scores of 1 (Very Much Improved) or 2 (Much Improved) Indicate an Acceptable Treatment Response.
CGI-I Week 4
|
3.03 units on a scale
Interval 2.78 to 3.28
|
3.38 units on a scale
Interval 3.09 to 3.67
|
|
Clinical Global Impression Scale - Improvement (CGI-I) Will be Used to Assess Overall Global Illness Improvement. CGI-I Scores of 1 (Very Much Improved) or 2 (Much Improved) Indicate an Acceptable Treatment Response.
CGI-I Week 8
|
2.65 units on a scale
Interval 2.23 to 3.07
|
3.24 units on a scale
Interval 2.88 to 3.61
|
|
Clinical Global Impression Scale - Improvement (CGI-I) Will be Used to Assess Overall Global Illness Improvement. CGI-I Scores of 1 (Very Much Improved) or 2 (Much Improved) Indicate an Acceptable Treatment Response.
CGI-I Week 2
|
3.48 units on a scale
Interval 3.25 to 3.72
|
3.68 units on a scale
Interval 3.44 to 3.93
|
PRIMARY outcome
Timeframe: Weeks 0, 2, 4, and 8Population: Analysis week 8
Clinical Global Impression Scale - Severity (CGI-S) is a 7-point scale is a clinician-completed measure that requires the clinician to rate the severity of the patient's illness at the time of assessment relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of illness at the time of rating, with values ranging from 1 (normal, not at all ill), 2 (borderline ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), to 7 (extremely ill).
Outcome measures
| Measure |
Citalopram
n=40 Participants
Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2).
Citalopram: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
Placebo
n=41 Participants
Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.
Placebo: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
|---|---|---|
|
Clinical Global Impression Scale - Severity (CGI-S)
CGI-S Week 0
|
4.31 units on a scale
Interval 3.93 to 4.69
|
4.39 units on a scale
Interval 4.14 to 4.64
|
|
Clinical Global Impression Scale - Severity (CGI-S)
CGI-S Week 2
|
3.83 units on a scale
Interval 3.45 to 4.21
|
4.03 units on a scale
Interval 3.7 to 4.35
|
|
Clinical Global Impression Scale - Severity (CGI-S)
CGI-S Week 4
|
3.56 units on a scale
Interval 3.25 to 3.87
|
3.86 units on a scale
Interval 3.54 to 4.19
|
|
Clinical Global Impression Scale - Severity (CGI-S)
CGI-S Week 8
|
2.76 units on a scale
Interval 2.38 to 3.13
|
3.51 units on a scale
Interval 3.07 to 3.96
|
PRIMARY outcome
Timeframe: Weeks 0, 2, 4, and 8Population: Analysis week 8
The API is a well-validated and reliable measure of abdominal pain assessing the frequency, duration, and intensity of abdominal pain consisting of five items assessing the frequency, duration, and intensity of abdominal pain experienced during the prior 2 weeks. Two of the items are scored from 0 to 5, one is scaled 0 to 8, and two are scaled 0 to 10, with lower scores considered to be better than higher scores. Item scores are standardized using Z-scores and then summed to yield an index of abdominal pain that has been sensitive to change in previous epidemiological and treatment studies of FAP. Alpha reliability ranged from 0.80 to 0.93. The API will be a continuous primary outcome measure of abdominal pain.
Outcome measures
| Measure |
Citalopram
n=40 Participants
Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2).
Citalopram: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
Placebo
n=41 Participants
Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.
Placebo: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
|---|---|---|
|
Abdominal Pain Index (API)
API-C Week 2
|
-0.14 score on a scale
Interval -0.43 to 0.14
|
0.06 score on a scale
Interval -0.19 to 0.31
|
|
Abdominal Pain Index (API)
API-C Week 4
|
-0.21 score on a scale
Interval -0.5 to 0.08
|
0.08 score on a scale
Interval -0.2 to 0.36
|
|
Abdominal Pain Index (API)
API-C Week 8
|
-0.36 score on a scale
Interval -0.65 to -0.06
|
-0.03 score on a scale
Interval -0.34 to 0.27
|
|
Abdominal Pain Index (API)
API-C Week 0
|
0.45 score on a scale
Interval 0.2 to 0.69
|
0.47 score on a scale
Interval 0.27 to 0.68
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, and 8Population: Analysis week 8
Pediatric Anxiety Rating Scale (PARS) is a clinician administered measure of anxiety in children and adolescents. The PARS is comprised of a 50-item symptom checklist used to determine the presence or absence of specific anxiety symptoms during the prior week and 7 severity/impairment items, each scored from 0 to 5 . The the score on the 7 items allows the clinician to rate symptom severity and associated impairment on a range from 0 to 35, with higher scores reflecting greater symptom severity and associated impairment. The PARS is characterized by high interrater reliability (ICC = 0.97), adequate internal consistency (α = 0.64), and fair test-retest reliability (ICC = 0.55). There is preliminary support for convergent and divergent validity, and the PARS has demonstrated sensitivity to treatment effects in previously conducted clinical trials.
Outcome measures
| Measure |
Citalopram
n=40 Participants
Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2).
Citalopram: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
Placebo
n=41 Participants
Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.
Placebo: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
|---|---|---|
|
Pediatric Anxiety Rating Scale (PARS)
PARS Week 8
|
2.69 units on a scale
Interval 1.66 to 3.73
|
5.55 units on a scale
Interval 3.71 to 7.39
|
|
Pediatric Anxiety Rating Scale (PARS)
PARS Week 4
|
2.57 units on a scale
Interval 1.55 to 3.59
|
5.76 units on a scale
Interval 3.79 to 7.72
|
|
Pediatric Anxiety Rating Scale (PARS)
PARS Week 0
|
7.38 units on a scale
Interval 5.66 to 9.11
|
9.73 units on a scale
Interval 7.76 to 11.7
|
|
Pediatric Anxiety Rating Scale (PARS)
PARS Week 2
|
4.00 units on a scale
Interval 2.81 to 5.19
|
6.78 units on a scale
Interval 4.8 to 8.75
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, and 8Population: Analysis week 8
Children's Depression Rating Scale - Revised (CDRS-R) is a clinician administered measure of depression in children and adolescents and provides data necessary to diagnose depressive disorder and rate the severity of depressive symptoms over time. The CDRS-R is composed of 17 items, most rated on a 1 to 7 scale, with a minimum score of 17 and a maximum of 113. Higher scores reflect greater depression severity, with scores of 40 and above generally considered to be reflective of a depressive diagnosis.
Outcome measures
| Measure |
Citalopram
n=40 Participants
Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2).
Citalopram: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
Placebo
n=41 Participants
Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.
Placebo: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
|---|---|---|
|
Children's Depression Rating Scale - Revised (CDRS-R)
CDRS-R Week 2
|
27.81 units on a scale
Interval 24.76 to 30.86
|
31.89 units on a scale
Interval 27.8 to 35.99
|
|
Children's Depression Rating Scale - Revised (CDRS-R)
CDRS-R Week 4
|
24.97 units on a scale
Interval 22.31 to 27.62
|
28.35 units on a scale
Interval 25.01 to 31.69
|
|
Children's Depression Rating Scale - Revised (CDRS-R)
CDRS-R Week 0
|
34.50 units on a scale
Interval 30.32 to 38.68
|
39.23 units on a scale
Interval 35.02 to 43.44
|
|
Children's Depression Rating Scale - Revised (CDRS-R)
CDRS-R Week 8
|
23.88 units on a scale
Interval 21.17 to 26.6
|
28.39 units on a scale
Interval 23.32 to 33.47
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, and 8Population: Analysis week 8
Children's Global Assessment Scale (C-GAS) is an interview-based adaptation of the Global Assessment Scale developed to assess child and adolescent functioning during a specified time period. Scores range from one to 100, with scores of 70 or below reflecting abnormally low functioning and higher scores reflecting better functioning. The C-GAS has demonstrated reliability, as well as discriminant and concurrent validity. A CGAS score of \< 70 will be a requirement at study entry.
Outcome measures
| Measure |
Citalopram
n=40 Participants
Citalopram was initiated at 10 mg daily for one week, with dosage increased to 20 mg daily during week 2, with an optional increase to 40 mg daily at week 4 or thereafter if response was judged to be suboptimal (CGI-I or CGI-S \> 2).
Citalopram: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
Placebo
n=41 Participants
Placebo administered in capsules identical to those containing citalopram using microcrystalline cellulose.
Placebo: Participants will be randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response is suboptimal and there are no significant side effects.
|
|---|---|---|
|
Children's Global Assessment Scale (C-GAS)
CGAS Week 0
|
54.42 units on a scale
Interval 51.95 to 56.89
|
54.07 units on a scale
Interval 51.77 to 56.38
|
|
Children's Global Assessment Scale (C-GAS)
CGAS Week 2
|
59.24 units on a scale
Interval 55.98 to 62.49
|
58.05 units on a scale
Interval 54.61 to 61.49
|
|
Children's Global Assessment Scale (C-GAS)
CGAS Week 4
|
63.27 units on a scale
Interval 60.05 to 66.5
|
59.14 units on a scale
Interval 56.1 to 62.17
|
|
Children's Global Assessment Scale (C-GAS)
CGAS Week 8
|
66.72 units on a scale
Interval 62.74 to 70.7
|
61.22 units on a scale
Interval 57.47 to 64.97
|
Adverse Events
Citalopram
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Citalopram
n=40 participants at risk
Citlaopram: Participants were randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects.
|
Placebo
n=41 participants at risk
Placebo: Participants were randomly assigned to citalopram or placebo in a parallel groups design for 8 weeks of double-blind treatment beginning with 10 mg per day week 1, 20 mg per day week 2, and 40 mg per day week 4 or thereafter if response was suboptimal and there were no significant side effects.
|
|---|---|---|
|
Gastrointestinal disorders
gastric distress
|
32.5%
13/40 • 8 weeks
|
34.1%
14/41 • 8 weeks
|
|
Metabolism and nutrition disorders
appetite or weight change
|
27.5%
11/40 • 8 weeks
|
48.8%
20/41 • 8 weeks
|
|
Eye disorders
vision disturbance
|
5.0%
2/40 • 8 weeks
|
7.3%
3/41 • 8 weeks
|
|
Nervous system disorders
dizziness
|
40.0%
16/40 • 8 weeks
|
39.0%
16/41 • 8 weeks
|
|
Nervous system disorders
headache
|
77.5%
31/40 • 8 weeks
|
87.8%
36/41 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
itching
|
27.5%
11/40 • 8 weeks
|
19.5%
8/41 • 8 weeks
|
|
General disorders
fatigue
|
50.0%
20/40 • 8 weeks
|
68.3%
28/41 • 8 weeks
|
|
Gastrointestinal disorders
nausea or vomiting
|
52.5%
21/40 • 8 weeks
|
58.5%
24/41 • 8 weeks
|
|
General disorders
body aches
|
72.5%
29/40 • 8 weeks
|
75.6%
31/41 • 8 weeks
|
|
Cardiac disorders
palpitations
|
30.0%
12/40 • 8 weeks
|
29.3%
12/41 • 8 weeks
|
|
Gastrointestinal disorders
bowel movement disturbance
|
50.0%
20/40 • 8 weeks
|
51.2%
21/41 • 8 weeks
|
|
Eye disorders
eye irritation
|
7.5%
3/40 • 8 weeks
|
4.9%
2/41 • 8 weeks
|
|
General disorders
dry mouth
|
12.5%
5/40 • 8 weeks
|
4.9%
2/41 • 8 weeks
|
|
Ear and labyrinth disorders
earache
|
12.5%
5/40 • 8 weeks
|
9.8%
4/41 • 8 weeks
|
|
General disorders
nosebleed
|
10.0%
4/40 • 8 weeks
|
9.8%
4/41 • 8 weeks
|
|
Ear and labyrinth disorders
hearing disturbance
|
12.5%
5/40 • 8 weeks
|
9.8%
4/41 • 8 weeks
|
|
General disorders
throat pain
|
27.5%
11/40 • 8 weeks
|
24.4%
10/41 • 8 weeks
|
|
Nervous system disorders
motor disturbances (tics, twitches)
|
12.5%
5/40 • 8 weeks
|
7.3%
3/41 • 8 weeks
|
|
Renal and urinary disorders
urinary disturbance
|
17.5%
7/40 • 8 weeks
|
24.4%
10/41 • 8 weeks
|
|
Infections and infestations
upper respiratory infection
|
25.0%
10/40 • 8 weeks
|
26.8%
11/41 • 8 weeks
|
|
General disorders
sweating
|
5.0%
2/40 • 8 weeks
|
4.9%
2/41 • 8 weeks
|
|
General disorders
accidental injuries
|
7.5%
3/40 • 8 weeks
|
4.9%
2/41 • 8 weeks
|
|
Nervous system disorders
hyperactive
|
27.5%
11/40 • 8 weeks
|
43.9%
18/41 • 8 weeks
|
|
Psychiatric disorders
aggression
|
7.5%
3/40 • 8 weeks
|
2.4%
1/41 • 8 weeks
|
|
Psychiatric disorders
nightmares
|
10.0%
4/40 • 8 weeks
|
2.4%
1/41 • 8 weeks
|
|
Psychiatric disorders
irritability
|
20.0%
8/40 • 8 weeks
|
41.5%
17/41 • 8 weeks
|
|
General disorders
sleep disturbance
|
52.5%
21/40 • 8 weeks
|
68.3%
28/41 • 8 weeks
|
|
Psychiatric disorders
anxiety and panic
|
17.5%
7/40 • 8 weeks
|
36.6%
15/41 • 8 weeks
|
|
Psychiatric disorders
mood lability
|
7.5%
3/40 • 8 weeks
|
4.9%
2/41 • 8 weeks
|
|
Psychiatric disorders
sadness, depression
|
22.5%
9/40 • 8 weeks
|
24.4%
10/41 • 8 weeks
|
|
Nervous system disorders
memory disturbance
|
7.5%
3/40 • 8 weeks
|
2.4%
1/41 • 8 weeks
|
|
General disorders
fever
|
5.0%
2/40 • 8 weeks
|
4.9%
2/41 • 8 weeks
|
|
General disorders
hair loss
|
5.0%
2/40 • 8 weeks
|
0.00%
0/41 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place