Trial Outcomes & Findings for Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder (NCT NCT00149799)
NCT ID: NCT00149799
Last Updated: 2017-12-05
Results Overview
We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
100 participants
Primary outcome timeframe
Phase II: Biweekly for six months after randomization
Results posted on
2017-12-05
Participant Flow
A total of 100 participants received open-label escitalopram in Phase I. Only those who completed Phase I, met criteria for response, and were willing to continue on in the study were subsequently randomized in Phase II (n=58).
Participant milestones
| Measure |
Phase I: Open-Label Escitalopram
Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
|
Phase II: Double-blind Escitalopram
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
|
Phase II: Double-blind Placebo
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
|
|---|---|---|---|
|
Open Label Escitalopram (Phase I)
STARTED
|
100
|
0
|
0
|
|
Open Label Escitalopram (Phase I)
COMPLETED
|
74
|
0
|
0
|
|
Open Label Escitalopram (Phase I)
NOT COMPLETED
|
26
|
0
|
0
|
|
Discontinuation (Phase II)
STARTED
|
0
|
28
|
30
|
|
Discontinuation (Phase II)
COMPLETED
|
0
|
25
|
21
|
|
Discontinuation (Phase II)
NOT COMPLETED
|
0
|
3
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Escitalopram in the Treatment of Body Dysmorphic Disorder
Baseline characteristics by cohort
| Measure |
Phase II: Escitalopram
n=28 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
|
Phase II: Placebo
n=30 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
|
Total
n=58 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
30 participants
n=7 Participants
|
58 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Phase II: Biweekly for six months after randomizationPopulation: Intent-to-treat analysis of all 58 patients randomized to Phase II.
We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II.
Outcome measures
| Measure |
Phase II: Escitalopram
n=28 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
|
Phase II: Placebo
n=30 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
|
|---|---|---|
|
Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)
|
18 percentage of subjects who relapsed
|
40 percentage of subjects who relapsed
|
SECONDARY outcome
Timeframe: Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14We calculated the proportion of patients who achieved response in Phase I, defined as a \>=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit.
Outcome measures
| Measure |
Phase II: Escitalopram
n=100 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
|
Phase II: Placebo
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
|
|---|---|---|
|
Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)
|
67 percentage of subjects who responded
|
—
|
SECONDARY outcome
Timeframe: Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40Population: A total of 58 participants who had responded to open-label Escitalopram (phase 1) were randomized to receive either Escitalopram (n=28) or placebo (n=30) in the double-blind relapse prevent trial (phase 2). Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below.
Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression.
Outcome measures
| Measure |
Phase II: Escitalopram
n=28 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
|
Phase II: Placebo
n=30 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
|
|---|---|---|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 32
|
2.9565217 units on a scale
Standard Deviation 3.067102
|
4.2 units on a scale
Standard Deviation 4.007887
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 14
|
3.5357143 units on a scale
Standard Deviation 4.4010280
|
3.3793103 units on a scale
Standard Deviation 3.3744184
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 16
|
3.8928571 units on a scale
Standard Deviation 4.1840906
|
4.2333333 units on a scale
Standard Deviation 3.9799786
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 18
|
5.2857143 units on a scale
Standard Deviation 5.5099717
|
6.3703704 units on a scale
Standard Deviation 6.4875511
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 20
|
4.8461538 units on a scale
Standard Deviation 5.5403416
|
5.4285714 units on a scale
Standard Deviation 4.7798076
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 22
|
4.2307692 units on a scale
Standard Deviation 3.5922995
|
3.7407407 units on a scale
Standard Deviation 3.0457106
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 24
|
3.625 units on a scale
Standard Deviation 3.3337862
|
3.7727273 units on a scale
Standard Deviation 3.0539875
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 26
|
3.8695652 units on a scale
Standard Deviation 4.0486176
|
4.04 units on a scale
Standard Deviation 3.8457769
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 28
|
4.48 units on a scale
Standard Deviation 5.0259327
|
4.4090909 units on a scale
Standard Deviation 3.4731499
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 30
|
2.85 units on a scale
Standard Deviation 3.9373381
|
4.5454545 units on a scale
Standard Deviation 4.0676104
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 34
|
3.375 units on a scale
Standard Deviation 3.2412088
|
4.7 units on a scale
Standard Deviation 4.5664682
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 36
|
4.0416667 units on a scale
Standard Deviation 3.9943348
|
5.4 units on a scale
Standard Deviation 5.2555735
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 38
|
3.8181818 units on a scale
Standard Deviation 3.8623502
|
3.4666667 units on a scale
Standard Deviation 3.8705235
|
|
Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 40
|
4.2400000 units on a scale
Standard Deviation 4.8500859
|
4.1578947 units on a scale
Standard Deviation 5.0250833
|
SECONDARY outcome
Timeframe: Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)Population: 28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.
Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning.
Outcome measures
| Measure |
Phase II: Escitalopram
n=28 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
|
Phase II: Placebo
n=30 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
|
|---|---|---|
|
Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 14
|
9.0000000 units on a scale
Standard Deviation 2.6943013
|
8.2413793 units on a scale
Standard Deviation 2.3551641
|
|
Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 28
|
9.8000000 units on a scale
Standard Deviation 3.3040379
|
9.0000000 units on a scale
Standard Deviation 2.7961012
|
|
Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 40
|
9.7600000 units on a scale
Standard Deviation 3.6887215
|
8.8947368 units on a scale
Standard Deviation 3.1428002
|
SECONDARY outcome
Timeframe: Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)Population: 28 in Escitalopram and 30 were randomized to Placebo after phase-1 open label. Some of the assessments visits were missed due to patient cancellations or study dropouts. The exact numbers analyzed are as specified below. Note: each participant included (28 Escitalopram, 30 placebo) was assessed at least once during phase 2.
Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES\_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction.
Outcome measures
| Measure |
Phase II: Escitalopram
n=28 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
|
Phase II: Placebo
n=30 Participants
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
|
|---|---|---|
|
Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 14
|
74.1785714 Percentage score
Standard Deviation 12.9930282
|
70.9259259 Percentage score
Standard Deviation 16.0166402
|
|
Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 28
|
70.2727273 Percentage score
Standard Deviation 14.1528453
|
67.3684211 Percentage score
Standard Deviation 16.0665648
|
|
Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
Week 40
|
69.0833333 Percentage score
Standard Deviation 18.5376624
|
68.6470588 Percentage score
Standard Deviation 15.2436100
|
Adverse Events
Phase I: Open-Label Escitalopram
Serious events: 0 serious events
Other events: 89 other events
Deaths: 0 deaths
Phase II: Escitalopram
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Phase II: Placebo
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase I: Open-Label Escitalopram
n=100 participants at risk
Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
|
Phase II: Escitalopram
n=28 participants at risk
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
|
Phase II: Placebo
n=30 participants at risk
At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
0.00%
0/100 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/30 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Gastrointestinal disorders
Vomiting
|
1.0%
1/100 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 3 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/30 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Endocrine disorders
Hot Flashes
|
0.00%
0/100 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/28 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
6.7%
2/30 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
General disorders
Yawning
|
5.0%
5/100 • Number of events 5 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/28 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
6.7%
2/30 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.0%
2/100 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/28 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
6.7%
2/30 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Cardiac disorders
Heart Palpitations
|
2.0%
2/100 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.6%
1/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
6.7%
2/30 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Skin and subcutaneous tissue disorders
Poison Ivy
|
0.00%
0/100 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/28 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
6.7%
2/30 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
General disorders
Restless Sleep / Not Insomnia
|
0.00%
0/100 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/28 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
6.7%
2/30 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
General disorders
Fatigue
|
42.0%
42/100 • Number of events 55 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
21.4%
6/28 • Number of events 7 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
13.3%
4/30 • Number of events 4 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Gastrointestinal disorders
Nausea
|
36.0%
36/100 • Number of events 43 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
10.7%
3/28 • Number of events 4 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
13.3%
4/30 • Number of events 4 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Reproductive system and breast disorders
Sexual Dysfunction
|
31.0%
31/100 • Number of events 33 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.3%
1/30 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Psychiatric disorders
Insomnia
|
34.0%
34/100 • Number of events 37 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
10.7%
3/28 • Number of events 4 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
23.3%
7/30 • Number of events 7 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
General disorders
Dry Mouth
|
28.0%
28/100 • Number of events 30 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.6%
1/28 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
10.0%
3/30 • Number of events 3 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
General disorders
Headache
|
41.0%
41/100 • Number of events 58 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
32.1%
9/28 • Number of events 18 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
30.0%
9/30 • Number of events 16 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Metabolism and nutrition disorders
Change in Appetite
|
23.0%
23/100 • Number of events 25 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.6%
1/28 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
10.0%
3/30 • Number of events 3 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Psychiatric disorders
Agitation
|
12.0%
12/100 • Number of events 13 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/28 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.3%
1/30 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
General disorders
Dizziness
|
6.0%
6/100 • Number of events 6 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.6%
1/28 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
20.0%
6/30 • Number of events 6 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Psychiatric disorders
Irritability
|
6.0%
6/100 • Number of events 6 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
13.3%
4/30 • Number of events 4 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
General disorders
Sweating
|
8.0%
8/100 • Number of events 11 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.6%
1/28 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.3%
1/30 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Gastrointestinal disorders
Flatulence
|
10.0%
10/100 • Number of events 10 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 4 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.3%
1/30 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Psychiatric disorders
Somnolence
|
8.0%
8/100 • Number of events 9 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/28 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.3%
1/30 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
10/100 • Number of events 11 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
17.9%
5/28 • Number of events 9 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/30 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.0%
7/100 • Number of events 7 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.3%
1/30 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Psychiatric disorders
Anxiety
|
6.0%
6/100 • Number of events 9 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.6%
1/28 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
6.7%
2/30 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Cold Symptoms
|
7.0%
7/100 • Number of events 10 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
14.3%
4/28 • Number of events 6 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
10.0%
3/30 • Number of events 4 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Gastrointestinal disorders
Indigestion
|
4.0%
4/100 • Number of events 5 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/30 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
General disorders
Vivid Dreams
|
5.0%
5/100 • Number of events 5 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/30 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Reproductive system and breast disorders
Menstrual Cramps
|
3.0%
3/100 • Number of events 4 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
3.3%
1/30 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
1.0%
1/100 • Number of events 1 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
7.1%
2/28 • Number of events 2 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
0.00%
0/30 • Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14; Phase II: Biweekly for six months after randomization
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place