Treatment of Pediatric Anxiety Disorders by Predicting Treatment Response Through Biocellular Markers and Sleep

This is an interventional diagnostic trial for Generalized Anxiety Disorder focused on measuring anxiety, SSRI, biomarker, sleep, children, adolescents, young adults Read More

Inclusion Criteria:

1. Participants aged 8-25 years inclusive at the time of the consent/assent, either outpatient or inpatient if hospitalization is required for one of the following reasons:

   • It is presently unsafe for subject to stay at home because he/she may run away
   • Subject needs closer monitoring while being started on medications
   • Subject needs a level of care that is greater than once a week outpatient treatment and is willing to participate in the study.
2. Participant's parent or legally authorized representative (LAR) must provide signature of informed consent, and there must be documentation of assent by the participant.
3. Participant meets Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) or Fifth Edition (DSM-V) criteria for a clinically impairing anxiety disorder based on detailed psychiatric evaluation at screening including completion of the Anxiety Disorders Interview Schedule for DSM-IV or DSM-V Child Version (ADIS-C) and a Children's Global Assessment Scale (CGAS) score less than 65.

4. Participants who are female of child-bearing potential (defined as ≥9 years of age or if <9 years of age are post-menarchal) must have a negative urine pregnancy test at the Baseline Visit. Females of child-bearing potential must abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception. Condoms should be used with the following acceptable contraceptives:

   • Intrauterine devices,
   • Hormonal contraceptives (oral, depot, patch, injectable, or vaginal ring).
   • Other acceptable contraceptive methods are double barrier methods (e.g., condoms and diaphragms with spermicidal gel or foam).

Exclusion Criteria:

1. Participant has a current co-morbid psychiatric diagnosis of bipolar disorder, psychosis, a pervasive developmental disorder other than Asperger's Syndrome, an eating disorder, substance abuse disorder, or a sleep disorder of narcolepsy and/or sleep apnea.
2. Participant has any condition or illness which, in the opinion of the study doctor, represents as an inappropriate risk to the participant and/or could confound the interpretation of the study.
3. Participant has received any evidence-based psychosocial intervention in the past 6 weeks i.e. Individual Cognitive Behavioral Therapy, Group Cognitive Behavioral Therapy, or Social Effectiveness Training.
4. Participant is unwilling or unable to provide blood, urine, and/or saliva samples at designated visits.
5. Participant is female and is pregnant or is currently lactating.
6. Participant is currently considered at risk for suicide in the opinion of the study doctor, has made a suicide attempt within the past 6 months, or is currently reporting active suicidal ideation. Participants with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the study doctor. Control participants with any suicidal ideation will not be eligible for the study.
7. Participant has had a substance use disorder within the past 6 months.
8. Participant has a clinically important abnormality on drug and alcohol screen.
9. Participant has started or changed the dosage of medication (including herbal supplements) that has anxiolytic, anxiogenic, or central nervous system (CNS) effects within the past 3 months.
10. Participant has a known or suspected allergy, hypersensitivity, or clinically significant intolerance to any components found in the study drug.
11. Participant has had several failed attempts with SSRI treatment.
12. Participant has an acute illness and/or is taking short term medication at the time of initiation of the study.
13. Participant failed screening or was previously enrolled in this study
14. Participant is unable to read.