Fluoxetine vs CBT in Childhood Anxiety Disorders

Inclusion Criteria:

• Patients ages 8-17

• Patients screening positive (score ≥3) on the SCARED-5 (possible range 0-10, higherscores indicate greater severity) and positive (score ≥25) on the SCARED-41 (possible range 0-82, higher scores indicate greater severity).

• Patients with an anxiety disorder (generalized anxiety, separation anxiety, panic,or social anxiety) on the Schedule for Affective Disorders and Schizophrenia forSchool-Aged Children, computerized version (KSADS-COMP).

• Patients with a score of >8 on the Child Anxiety Impact Scale (CAIS- possible rangeof scores is 0-81, higher scores indicate greater impact) representing at leastmoderately severe illness.

• Patients and at least one parent/caregiver of all ages, who are fluent in eitherEnglish or Spanish.

• Patient and their parent agree for the child to be randomized to either fluoxetineor CBT.

Exclusion Criteria:

• Patients with a neurological disorder or unstable medical condition, as determinedby medical chart and medical history review by the site director and PI.

• Females who are pregnant or sexually active but not using an effective method ofbirth control (potential adverse fetal effects of medication).

• Patients with any of the following characteristics/conditions on theColumbia-Suicide Severity Rating Scale (CSSRS- possible range of scores 0-5, higherscores representing greater severity):

1. Patients scoring a 3 AND access to crisis level support is unavailable OR

2. Patients scoring a 4 if frequency, duration, and deterrent all = 1 ANDtreatment in a specialty mental health clinic is not available OR

3. Patients scoring a 4 if frequency, duration, OR deterrents are > 1

4. Patients scoring a 5 4. Due to the cognitive and socio-emotional demands of theCBT protocol, we will exclude youths who are likely to be functioning at adevelopmental level outside the minimum age for the treatment manual (age 8):Youths who are placed outside of a general education (GE) classroom for > 50%of the school day or require a one-on-one classroom aide to maintain placementin a GE class, or are performing academically below the 2nd grade level inreading and language arts.

• Patients with a current obsessive-compulsive disorder (OCD) diagnosis, for whichthis study's treatments would be inappropriate clinically and ethically, on theKSADS-COMP.

• Patients with a current post-traumatic stress disorder (PTSD) diagnosis, for whichthis study's treatments would be inappropriate clinically and ethically, with thefollowing characteristics/conditions on the Child Trauma Screen (CTS) andKSADS-COMP: a. Patients scoring at least 1 past trauma on the events portion of the CTS AND areaction score ≥10 (possible range of scores 0-18, with higher scores representingmore severe reactions) on the parent report.

• Patients currently receiving fluoxetine. Those who are currently receiving any otherselective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptakeinhibitor (SNRI), other antidepressant, or benzodiazepine for the treatment ofeither anxiety or sleep disturbance and who otherwise meet all eligibilityrequirement will be permitted to taper and discontinue their medication to enter thestudy if they wish to do so and if they otherwise still meet all eligibilityrequirements after the taper.

Psychopharmacologists on the study team will provide guidelines for the medication taper and discontinuation, but the patient's previously prescribing clinician must first agree that the taper is clinically reasonable and agree to conduct the taper after first discussing the risks and benefits of the taper and discontinuation with the child and parent(s). The study term will not conduct or oversee the medication taper.

• Patients who have taken Monoamine Oxidase Inhibitors (MAOIs), Pimozide,Thioridazine, Olanzapine, Tricyclic Antidepressants (TCAs), Antipsychotics such asHaloperidol and Clozapine, Anticonvulsants such as Phenytoin and Carbamazepinewithin 2 weeks prior to starting the study.

• Patients currently in foster care.

• Patients currently receiving psychotherapy. a. Patients who are receiving psychotherapy and who, together with their parents andtreating clinician, agree that it is reasonable either to pause or discontinue theirpsychotherapy for the duration of the 24-week trial, will be permitted to do so andmay then enroll in our SMART study.

• Patients with a past diagnosis of Bipolar Disorder, as determined by medical chartand medical history review by the site director and PI OR Patients who score ≥18 onthe Parent General Behavior Inventory-10-Item Mania Scale (PGBI-10M) (possible range 0-30, higher scores representing an increased likelihood of diagnosis).

• Patients with a current/active psychotic diagnosis (schizophrenia, schizoaffective,schizophreniform, psychosis not otherwise specified (NOS), or depression withpsychotic features), as determined by medical chart and medical history review bythe site director and PI.