Trial Outcomes & Findings for Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep (NCT NCT02189213)
NCT ID: NCT02189213
Last Updated: 2021-10-11
Results Overview
The CGI-I score at the final visit will determine treatment response. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment.
TERMINATED
NA
14 participants
Final visit, at 12 weeks of treatment
2021-10-11
Participant Flow
Participant milestones
| Measure |
Sertraline
Sertraline was administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:
Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks, or, the titration was stopped at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration.
|
Healthy Control
Healthy control will not be treated.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
1
|
|
Overall Study
COMPLETED
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep
Baseline characteristics by cohort
| Measure |
Sertraline
n=13 Participants
Sertraline will be administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:
Sertraline will be titrated from 25mg once a day orally up to 200mg once a day orally, for 12 weeks, or the titration will stop at the dose in which the participant shows a full response to the medication or experiences side effects that will inhibit titration.
|
Control
n=1 Participants
There will be no intervention in this arm.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
5 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
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 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
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
11 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
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
1 participants
n=4 Participants
|
14 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Final visit, at 12 weeks of treatmentPopulation: There were two males and two females in the responder group and two females and one male in the non-responder group.
The CGI-I score at the final visit will determine treatment response. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale. The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment.
Outcome measures
| Measure |
Sertraline Responders
n=4 Participants
Responders will have either a score of 1 or 2 on the Clinical Global Impressions (CGI) Improvement Scale. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale.
The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment.
|
Sertraline Non-Responders
n=3 Participants
Non-Responders will have a score of 3 or greater than 3 on the Clinical Global Impressions (CGI) Improvement Scale. The CGI-Improvement scale comprises a one-item measures evaluating the following change from the initiation of treatment on a seven-point scale.
The following one query is rated on a seven-point scale: "Compared to the patient's condition at admission to the project \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.
CGI-I scale of 1-2 is considered response to treatment. Anything below that is considered non-response to sertraline treatment.
|
|---|---|---|
|
Clinical Global Impression-Improvement (CGI-I) Score
|
1.00 units on a scale
Standard Deviation 1.40
|
3.66 units on a scale
Standard Deviation 2.12
|
Adverse Events
Sertraline
Healthy Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place