Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep
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|ClinicalTrials.gov Identifier: NCT02189213|
Recruitment Status : Terminated (Insufficient funding)
First Posted : July 14, 2014
Results First Posted : October 11, 2021
Last Update Posted : October 11, 2021
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder Separation Anxiety Disorder Social Phobia||Drug: Sertraline||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
Active Comparator: Sertraline
Sertraline will be administered PO to treat anxiety disorders in children and adolescents. he 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. 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.
Sertraline will be administered to treat anxiety disorders in children and adolescents.
Other Name: Zoloft
No Intervention: Control
There will be no intervention in this arm.
- Clinical Global Impression-Improvement (CGI-I) Score [ Time Frame: Final visit, at 12 weeks of treatment ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189213
|United States, New York|
|New York, New York, United States, 10032|
|Principal Investigator:||Amir Levine||New York State Psychiatric Institue|