A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder

Conditions
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Anxiety Disorders,Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: Escitalopram
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's parent/legal representative must give written informed consent, including privacy authorization, prior to study participation. The subject will complete an informed assent prior to study participation. Subject meets DSM-5 criteria for a primary diagnosis of GAD at screening established by a comprehensive psychiatric evaluation and confirmed/supported using the Mini-International Neuropsychiatric Interview for children and adolescents (MINI Kid). Male subjects who are sexually active with a partner of childbearing potential must use, with their partner, a condom plus an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug. Female subjects who are sexually active and are of childbearing potential must use, with their partner, an approved method of highly effective contraception from the time of informed consent until 14 days after the last dose of study drug. Female subjects who are not of childbearing potential do not need to use any methods of contraception. This includes preadolescent and adolescent females who have not reached menarche. - Subject must have venous access enough to allow blood sampling and be compliant with blood draws as per the protocol. Exclusion Criteria: Current diagnosis of MDD, attention-deficit/hyperactivity disorder, or lifetime diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, feeding and/or eating disorder, obsessive-compulsive disorder, conduct disorder, oppositional defiant disorder, post-traumatic stress disorder, panic disorder, or pervasive development disorder. Suspected or previously diagnosed intellectual disability disorder. One or more first-degree relatives with diagnosed bipolar I disorder. History of seizure disorder (other than febrile seizures). History of electroconvulsive therapy at any time during the subject's lifetime. Known hypersensitivity to escitalopram (escitalopram oxalate) or citalopram or any of the inactive ingredients or had frequent or severe allergic reactions to multiple medications. Taking any medications that are contraindicated to escitalopram (escitalopram oxalate). Inability to speak, read, or understand English well enough to complete the assessments. No active suicidal ideation or lifetime history of suicidal behavior as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram 10 mg/day<br>Oral administration with the possibility of dose escalation to 20 mg/day at the investigator's discretion | Drug: Escitalopram<br>* 8-weeks of treatment followed by 1-week taper down period<br>|
| Placebo Comparator: Placebo<br>Matching oral administration of placebo once daily | Other: Placebo<br>* Matching oral administration of inactive substance once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate on the PARS | Response is defined as a 50% improvement on the PARS severity score for GAD | 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) | 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. | 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. | Week 8 |