A Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder
Condition: Anxiety Disorders,Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Intervention: Escitalopram; Placebo
Intervention description: 8-weeks of treatment followed by 1-week taper down period; Matching oral administration of inactive substance once daily
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 273.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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).