Acute and Long-Term Antidepressant Treatment Success in Adolescents With Anxiety (AtLAS-A) (AtLAS-A)
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|ClinicalTrials.gov Identifier: NCT04245436|
Recruitment Status : Not yet recruiting
First Posted : January 29, 2020
Last Update Posted : January 31, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depressive Symptoms||Drug: Duloxetine Drug: Escitalopram||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double Blind|
|Official Title:||Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up.|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||August 2024|
Active Comparator: Duloxetine
Patients randomized to duloxetine, treatment will be initiated at 30 mg qAM through Week 4 (V5) (consistent with the registration trial for duloxetine in pediatric patients with generalized anxiety disorder). Then, duloxetine will be increased to 60 mg qAM at Week 4 (V5) and will be continued at this dose until Week 6 (V6) or the end of the acute phase of the study. Beginning at Week 6 (V6), duloxetine may be increased to 90 mg daily and at Week 8 (V7), may be increased to 120 mg daily.
Encapsulated duloxetine 30 mg, 60 mg; once-daily
Active Comparator: Escitalopram
Patients randomized to escitalopram, will initiate treatment at 5 mg qAM for 1 week and then 10 mg qAM (the recommended starting dose for adolescents 12-17 years and the dose used in the pediatric registration trials). After Week 4 (V5), escitalopram will be increased to 15 mg and this dose will be continued until either Week 6 (V6) or the end of the acute phase of the study; however, at Week 6 (V6), escitalopram may be increased to 20 mg qAM based on efficacy.
Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily
Other Name: Lexapro
- Change from Baseline in Pediatric Anxiety Rating Scale (PARS) severity score [ Time Frame: Baseline to Week 24 months (Early Term) ]The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders in children and adolescents. The PARS score is derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7)
- Change from Baseline in the Clinical Global Impression of Severity (CGI-S) [ Time Frame: Baseline to Week 10 (Early Term) ]CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.
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): NCT04245436
|Contact: Jeffrey R Strawn, MDemail@example.com|
|Contact: Sara T Varneyfirstname.lastname@example.org|
|Principal Investigator:||Jeffrey R Strawn, MD||University of Cincinnati|