Trial Outcomes & Findings for Effects of Sertraline on Brain Connectivity in Adolescents With OCD (NCT NCT02797808)
NCT ID: NCT02797808
Last Updated: 2021-01-05
Results Overview
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) a clinician-rated semi-structured instrument assessing OCD severity over the previous 7 days in children ages 6 to 17 years. Items are scored from 0 (none) to 4 (extreme) and total score ranges from 0 to 40 with higher scores indicating greater impairment. All 19 items are rated, but only items 1-10 are used to determine the total score. The total CY-BOCS score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. At this time, items 1A and 6A are not being used in the scoring. Items 17 (global severity) and 18 (global improvement) are adapted from the Clinical Global Impression Scale to provide measures of overall functional impairment associated with the presence of obsessive-compulsive symptoms.
COMPLETED
PHASE1/PHASE2
41 participants
12 weeks
2021-01-05
Participant Flow
Participant milestones
| Measure |
Obsessive-compulsive Disorder
Sertraline: Impact of sertraline on functional brain connectivity
|
Healthy Controls
No Intervention: Healthy control non-intervention
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
18
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Obsessive-compulsive Disorder
Sertraline: Impact of sertraline on functional brain connectivity
|
Healthy Controls
No Intervention: Healthy control non-intervention
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Physician Decision
|
6
|
2
|
Baseline Characteristics
Effects of Sertraline on Brain Connectivity in Adolescents With OCD
Baseline characteristics by cohort
| Measure |
Obsessive-compulsive Disorder
n=23 Participants
Sertraline: Impact of sertraline on functional brain connectivity
|
Healthy Controls
n=18 Participants
No Intervention: Healthy control non-intervention
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
23 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
13.4 years
STANDARD_DEVIATION 2.6 • n=93 Participants
|
13.4 years
STANDARD_DEVIATION 2.9 • n=4 Participants
|
13.4 years
STANDARD_DEVIATION 2.75 • n=27 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
CY-BOCS Total Score at Baseline
|
24.8 units on a scale
STANDARD_DEVIATION 6.9 • n=93 Participants
|
0 units on a scale
STANDARD_DEVIATION 0 • n=4 Participants
|
24.8 units on a scale
STANDARD_DEVIATION 6.9 • n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 2 additional participants with OCD and 1 Healthy Control were removed from this analysis due to motion effects in the neuroimaging data.
The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) a clinician-rated semi-structured instrument assessing OCD severity over the previous 7 days in children ages 6 to 17 years. Items are scored from 0 (none) to 4 (extreme) and total score ranges from 0 to 40 with higher scores indicating greater impairment. All 19 items are rated, but only items 1-10 are used to determine the total score. The total CY-BOCS score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. At this time, items 1A and 6A are not being used in the scoring. Items 17 (global severity) and 18 (global improvement) are adapted from the Clinical Global Impression Scale to provide measures of overall functional impairment associated with the presence of obsessive-compulsive symptoms.
Outcome measures
| Measure |
Children With OCD
n=14 Participants
Sertraline: Impact of sertraline on functional brain connectivity
|
Healthy Control Children
n=14 Participants
No Intervention: Healthy control non-intervention
|
|---|---|---|
|
CY-BOCS Total Score at 12-weeks
|
14.1 units on a scale
Standard Deviation 8.5
|
0 units on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 2 additional participants with OCD and 1 Healthy Control were removed from this analysis due to motion effects in the neuroimaging data.
Participants had whole brain fMRI at baseline \&12 weeks. Whole brain connectivity in 6 striatal ROIs was performed. Two-way mixed effects ANOVAs were performed with FEAT. Clusters were significant if p \<.0042 based on .05/(6 ROIs x 2 tests/ROI). Mean z-score was found for each time point in each subject's connectivity map in each significant cluster. Within-group paired-sample t tests examined RSFC change over time in these metrics for each group. To investigate group X time interactions from the 2-way ANOVA, we compared mean z-scores within each significant cluster at baseline \& 12 weeks. Resulting numbers represented striatal connectivity for each individual at each time point. Within group paired sample t-tests examined RSFC change over time for each group. Bonferroni correction was applied to alpha level (2-tailed, p\<0.5/6 =.0083) for multiple testing. We do not have an a priori hypothesis as to whether increase or decrease in RSFC is a better outcome. Unit of measure is z-score.
Outcome measures
| Measure |
Children With OCD
n=14 Participants
Sertraline: Impact of sertraline on functional brain connectivity
|
Healthy Control Children
n=14 Participants
No Intervention: Healthy control non-intervention
|
|---|---|---|
|
Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses
Connectivity z-scores for right putamen at baseline
|
0.15 z score
Standard Deviation 1.04
|
1.44 z score
Standard Deviation 1.06
|
|
Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses
Connectivity z-scores for left putamen at baseline
|
1.46 z score
Standard Deviation 1.14
|
2.41 z score
Standard Deviation 1.19
|
|
Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses
Connectivity z-scores for right putamen at 12 weeks
|
1.89 z score
Standard Deviation 0.85
|
0.60 z score
Standard Deviation 0.98
|
|
Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses
Connectivity z-scores for left putamen at week 12
|
3.03 z score
Standard Deviation 1.54
|
0.89 z score
Standard Deviation 0.99
|
Adverse Events
Obsessive-compulsive Disorder
Healthy Controls
Serious adverse events
| Measure |
Obsessive-compulsive Disorder
n=23 participants at risk
Sertraline: Impact of sertraline on functional brain connectivity
|
Healthy Controls
n=18 participants at risk
No Intervention: Healthy control non-intervention
|
|---|---|---|
|
Nervous system disorders
Seizure
|
4.3%
1/23 • Number of events 1 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
Other adverse events
| Measure |
Obsessive-compulsive Disorder
n=23 participants at risk
Sertraline: Impact of sertraline on functional brain connectivity
|
Healthy Controls
n=18 participants at risk
No Intervention: Healthy control non-intervention
|
|---|---|---|
|
General disorders
Medication Side Effect
|
34.8%
8/23 • Number of events 21 • 12 weeks
|
0.00%
0/18 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place