Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02189213|
Recruitment Status : Terminated
First Posted : July 14, 2014
Last Update Posted : March 10, 2021
|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)|
|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, 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|