Trial Outcomes & Findings for A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD (NCT NCT01372150)
NCT ID: NCT01372150
Last Updated: 2019-01-15
Results Overview
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
340 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2019-01-15
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Desvenlafaxine Succinate Sustained Release (DVS SR)
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
|---|---|---|---|
|
Overall Study
STARTED
|
112
|
113
|
115
|
|
Overall Study
Treated
|
112
|
112
|
115
|
|
Overall Study
COMPLETED
|
99
|
99
|
99
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
16
|
Reasons for withdrawal
| Measure |
Placebo
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Desvenlafaxine Succinate Sustained Release (DVS SR)
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
6
|
|
Overall Study
Protocol Violation
|
1
|
0
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
2
|
|
Overall Study
Other
|
1
|
0
|
2
|
|
Overall Study
Adverse Event
|
2
|
1
|
2
|
|
Overall Study
Randomized but not treated
|
0
|
1
|
0
|
Baseline Characteristics
A Study Of DVS SR In Treatment Of Children And Adolescent Outpatients With MDD
Baseline characteristics by cohort
| Measure |
Placebo
n=112 Participants
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
n=112 Participants
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
|
DVS SR
n=115 Participants
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
Total
n=339 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.6 Years
STANDARD_DEVIATION 2.89 • n=99 Participants
|
12.6 Years
STANDARD_DEVIATION 2.89 • n=107 Participants
|
12.9 Years
STANDARD_DEVIATION 3.12 • n=206 Participants
|
12.7 Years
STANDARD_DEVIATION 2.96 • n=7 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
184 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
155 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Intention-To-Treat (ITT) Population - included all randomized participants who received at least 1 dose of study drug, had a baseline primary efficacy assessment, and had at least one post-baseline primary efficacy assessment.
Clinician-rated interview-based scale (with both child and parent or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses were resolved by using most impaired rating given by valid informant. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Total score calculated as sum of the 17 items (range 1 to 119); higher score indicates greater impairment. Adjusted mean presented.
Outcome measures
| Measure |
Placebo
n=99 Participants
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
n=101 Participants
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
|
DVS SR
n=99 Participants
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the Children's Depression Rating Scale, Revised (CDRS-R) Total Score
|
-23.07 Score on a Scale
Standard Error 1.18
|
-24.79 Score on a Scale
Standard Error 1.17
|
-22.61 Score on a Scale
Standard Error 1.17
|
SECONDARY outcome
Timeframe: Baseline and Week 8Population: ITT Population
A 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline. Adjusted mean presented.
Outcome measures
| Measure |
Placebo
n=99 Participants
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
n=101 Participants
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
|
DVS SR
n=99 Participants
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
|---|---|---|---|
|
Change From Baseline to Week 8 in the Clinical Global Impression of Severity (CGI-S) Score
|
-1.71 Score on a Scale
Standard Error 0.12
|
-1.88 Score on a Scale
Standard Error 0.12
|
-1.70 Score on a Scale
Standard Error 0.11
|
SECONDARY outcome
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, and 8Population: ITT Population
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Outcome measures
| Measure |
Placebo
n=105 Participants
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
n=105 Participants
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
|
DVS SR
n=111 Participants
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
|---|---|---|---|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 3, Very Much Improved (n=105, 102, 107)
|
13.3 Percentage of Participants
|
14.7 Percentage of Participants
|
7.5 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 3, Very Much Worse (n=105, 102, 107)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 4, Very Much Improved (n=101, 101, 100)
|
15.8 Percentage of Participants
|
13.9 Percentage of Participants
|
20.0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 1, Very Much Improved (n=102, 101, 111)
|
1.0 Percentage of Participants
|
3.0 Percentage of Participants
|
2.7 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 1, Much Improved (n=102, 101, 111)
|
7.8 Percentage of Participants
|
11.9 Percentage of Participants
|
6.3 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 1, Minimally Improved (n=102, 101, 111)
|
46.1 Percentage of Participants
|
35.6 Percentage of Participants
|
43.2 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 1, No Change (n=102, 101, 111)
|
43.1 Percentage of Participants
|
47.5 Percentage of Participants
|
45.9 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 1, Minimally Worse (n=102, 101, 111)
|
2.0 Percentage of Participants
|
2.0 Percentage of Participants
|
1.8 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 1, Much Worse (n=102, 101, 111)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 1, Very Much Worse (n=102, 101, 111)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 2, Very Much Improved (n=103, 105, 110)
|
3.9 Percentage of Participants
|
6.7 Percentage of Participants
|
3.6 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 2, Much Improved (n=103, 105, 110)
|
25.2 Percentage of Participants
|
26.7 Percentage of Participants
|
31.8 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 2, Minimally Improved (n=103, 105, 110)
|
38.8 Percentage of Participants
|
42.9 Percentage of Participants
|
44.5 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 2, No Change (n=103, 105, 110)
|
30.1 Percentage of Participants
|
22.9 Percentage of Participants
|
19.1 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 2, Minimally Worse (n=103, 105, 110)
|
1.9 Percentage of Participants
|
1.0 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 2, Much Worse (n=103, 105, 110)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 2, Very Much Worse (n=103, 105, 110)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 3, Much Improved (n=105, 102, 107)
|
29.5 Percentage of Participants
|
36.3 Percentage of Participants
|
42.1 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 3, Minimally Improved (n=105, 102, 107)
|
41.0 Percentage of Participants
|
36.3 Percentage of Participants
|
38.3 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 3, No Change (n=105, 102, 107)
|
15.2 Percentage of Participants
|
11.8 Percentage of Participants
|
11.2 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 3, Minimally Worse (n=105, 102, 107)
|
1.0 Percentage of Participants
|
1.0 Percentage of Participants
|
0.9 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 3, Much Worse (n=105, 102, 107)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 4, Much Improved (n=101, 101, 100)
|
38.6 Percentage of Participants
|
47.5 Percentage of Participants
|
44.0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 4, Minimally Improved (n=101, 101, 100)
|
29.7 Percentage of Participants
|
27.7 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 4, No Change (n=101, 101, 100)
|
13.9 Percentage of Participants
|
9.9 Percentage of Participants
|
10.0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 4, Minimally Worse (n=101, 101, 100)
|
2.0 Percentage of Participants
|
1.0 Percentage of Participants
|
1.0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 4, Much Worse (n=101, 101, 100)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 4, Very Much Worse (n=101, 101, 100)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 6, Very Much Improved (n=100, 100, 102)
|
18.0 Percentage of Participants
|
26.0 Percentage of Participants
|
23.5 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 6, Much Improved (n=100, 100, 102)
|
41.0 Percentage of Participants
|
45.0 Percentage of Participants
|
45.1 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 6, Minimally Improved (n=100, 100, 102)
|
34.0 Percentage of Participants
|
24.0 Percentage of Participants
|
20.6 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 6, No Change (n=100, 100, 102)
|
6.0 Percentage of Participants
|
5.0 Percentage of Participants
|
9.8 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 6, Minimally Worse (n=100, 100, 102)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
1.0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 6, Much Worse (n=100, 100, 102)
|
1.0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 6, Very Much Worse (n=100, 100, 102)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 8, Very Much Improved (n=99, 101, 99)
|
27.3 Percentage of Participants
|
30.7 Percentage of Participants
|
23.2 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 8, Much Improved (n=99, 101, 99)
|
35.4 Percentage of Participants
|
47.5 Percentage of Participants
|
45.5 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 8, Minimally Improved (n=99, 101, 99)
|
32.3 Percentage of Participants
|
16.8 Percentage of Participants
|
21.2 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 8, No Change (n=99, 101, 99)
|
4.0 Percentage of Participants
|
4.0 Percentage of Participants
|
9.1 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 8, Minimally Worse (n=99, 101, 99)
|
1.0 Percentage of Participants
|
1.0 Percentage of Participants
|
1.0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 8, Much Worse (n=99, 101, 99)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants by Clinical Global Impression Improvement (CGI-I) Score at Weeks 1, 2, 3, 4, 6, and 8
Week 8, Very Much Worse (n=99, 101, 99)
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 3, 4, 6, and 8Population: ITT Population
A 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Outcome measures
| Measure |
Placebo
n=105 Participants
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
n=105 Participants
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
|
DVS SR
n=111 Participants
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
|---|---|---|---|
|
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Week 1 (n=102, 101, 111)
|
8.82 Percentage of Participants
|
14.85 Percentage of Participants
|
9.01 Percentage of Participants
|
|
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Week 2 (n=103, 105, 110)
|
29.13 Percentage of Participants
|
33.33 Percentage of Participants
|
35.45 Percentage of Participants
|
|
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Week 3 (n=105, 102, 107)
|
42.86 Percentage of Participants
|
50.98 Percentage of Participants
|
49.53 Percentage of Participants
|
|
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Week 4 (n=101, 101, 100)
|
54.46 Percentage of Participants
|
61.39 Percentage of Participants
|
64.00 Percentage of Participants
|
|
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Week 6 (n=100, 100, 102)
|
59.00 Percentage of Participants
|
71.00 Percentage of Participants
|
68.63 Percentage of Participants
|
|
Percentage of Participants With a CGI-I Response Defined as a Score of 'Very Much Improved' or 'Much Improved'
Week 8 (n=99, 101, 99)
|
62.63 Percentage of Participants
|
78.22 Percentage of Participants
|
68.69 Percentage of Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Fluoxetine
Serious events: 2 serious events
Other events: 39 other events
Deaths: 0 deaths
DVS SR
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=112 participants at risk
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
n=112 participants at risk
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
|
DVS SR
n=115 participants at risk
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
|---|---|---|---|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.87%
1/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.89%
1/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.87%
1/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.89%
1/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
0.00%
0/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Other adverse events
| Measure |
Placebo
n=112 participants at risk
Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
|
Fluoxetine
n=112 participants at risk
Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
|
DVS SR
n=115 participants at risk
DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
7/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
8.0%
9/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
13.0%
15/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
8.9%
10/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
11.6%
13/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
7.0%
8/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
3.6%
4/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
7/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
4.3%
5/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
General disorders
Fatigue
|
1.8%
2/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.4%
6/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.7%
2/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
1.8%
2/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.2%
6/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
8/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.2%
7/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.2%
6/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.4%
6/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
3.6%
4/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
5.2%
6/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
5.4%
6/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
2.7%
3/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
6.1%
7/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
|
Nervous system disorders
Headache
|
18.8%
21/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
14.3%
16/112 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
16.5%
19/115 • Adverse events (AEs) were recorded from informed consent and assent through the first follow up visit (Week 11) for non-serious AEs; the second follow up visit (Week 13) for serious AEs (SAEs); or at Week 9 for participants entering the extension study.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another participant, or 1 participant may have experienced both a serious and non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60