Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep
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|ClinicalTrials.gov Identifier: NCT02189213|
Recruitment Status : Active, not recruiting
First Posted : July 14, 2014
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Generalized Anxiety Disorder Separation Anxiety Disorder Social Phobia||Drug: Sertraline Drug: Fluoxetine Drug: Escitalopram||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 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|
|Estimated Study Completion Date :||December 2020|
Active Comparator: Sertraline, Fluoxetine, or Escitalopram
Sertraline, Fluoxetine, or Escitalopram will be administered PO to treat anxiety disorders in children and adolescents. One of the following dosing schedules will be used:
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
Fluoxetine will be administered to treat anxiety disorders in children and adolescents.
Other Name: Prozac
Lexapro will be administered to treat anxiety disorders in children and adolescents.
Other Name: Lexapro
No Intervention: Control
There will be no intervention in this arm.
- Clinical Global Impression-Improvement (CGI-I) Score [ Time Frame: 12 weeks ]The CGI-I score at the final visit (week 12) will determine treatment response.
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|