This is a study in minors (7 to 17 years old) diagnosed with generalized anxiety disorder (GAD) and evaluated using standard questionnaires as having at least moderate severity of GAD. Participating minors will be assigned to receive either the study drug escitalopram or a pill without any drug in it called a placebo. The purpose of this research is to study the safety and effectiveness of escitalopram in minors with GAD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
273
8-weeks of treatment followed by 1-week taper down period
Matching oral administration of inactive substance once daily
Change in Pediatric Anxiety Rating Scale (PARS) Severity Score
The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including generalized anxiety disorder (GAD) in children. The PARS severity score for GAD will be assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7) each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity.
Time frame: Baseline to Week 8
Response Rate on the PARS
Response is defined as a 50% improvement on the PARS severity score for GAD
Time frame: Week 8
Remission Rate on the PARS
Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7)
Time frame: Week 8
Change on the Clinical Global Impression of Severity (CGI-S)
Remission rate on CGI-S at acute treatment endpoint (Week 8). Remission rate is defined as the percentage of subjects having a CGI-S score ≤2 at endpoint. CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients.
Time frame: Week 8
Change on the Children's Global Assessment Scale (CGAS)
Remission rate on the CGAS at acute treatment endpoint (Week 8). Functional remission is defined as CGAS \>70. The CGAS used is a 100-point scale ranging from 1 to 100, with higher scores indicating better functioning.
Time frame: Week 8
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