Fluoxetine vs CBT in Childhood Anxiety Disorders (SMART)

This is an interventional treatment trial for Anxiety Disorders Read More

Inclusion Criteria:

1. Patients ages 8-17.
2. Patients screening positive (score ≥3) on the SCARED-5 (possible range 0-10, higher scores indicate greater severity) and positive (score ≥25) on the SCARED-41 (possible range 0-82, higher scores indicate greater severity).
3. Patients with an anxiety disorder (generalized anxiety, separation anxiety, panic, or social anxiety) on the Schedule for Affective Disorders and Schizophrenia for School-Aged Children, computerized version (KSADS-COMP).
4. Patients with a score of >8 on the Child Anxiety Impact Scale (CAIS- possible range of scores is 0-81, higher scores indicate greater impact) representing at least moderately severe illness.
5. Patients and at least one parent/caregiver of all ages, who are fluent in either English or Spanish.
6. Patient and their parent agree for the child to be randomized to either fluoxetine or CBT.

Exclusion Criteria:

1. Patients with a neurological disorder or unstable medical condition, as determined by medical chart and medical history review by the site director and PI.
2. Females who are pregnant or sexually active but not using an effective method of birth control (potential adverse fetal effects of medication).

3. Patients with any of the following characteristics/conditions on the Columbia-Suicide Severity Rating Scale (CSSRS- possible range of scores 0-5, higher scores 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 AND treatment 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 the CBT protocol, we will exclude youths who are likely to be functioning at a developmental 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 placement in a GE class, or are performing academically below the 2nd grade level in reading and language arts.
5. Patients with a current obsessive-compulsive disorder (OCD) diagnosis, for which this study's treatments would be inappropriate clinically and ethically, on the KSADS-COMP.

6. Patients with a current post-traumatic stress disorder (PTSD) diagnosis, for which this study's treatments would be inappropriate clinically and ethically, with the following characteristics/conditions on the Child Trauma Screen (CTS) and KSADS-COMP:

   a. Patients scoring at least 1 past trauma on the events portion of the CTS AND a reaction score ≥10 (possible range of scores 0-18, with higher scores representing more severe reactions) on the parent report.

7. Patients currently receiving fluoxetine. Those who are currently receiving any other selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI), other antidepressant, or benzodiazepine for the treatment of either anxiety or sleep disturbance and who otherwise meet all eligibility requirement will be permitted to taper and discontinue their medication to enter the study if they wish to do so and if they otherwise still meet all eligibility requirements 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 team will not conduct or oversee the medication taper.

8. Patients who have taken Monoamine Oxidase Inhibitors (MAOIs), Pimozide, Thioridazine, Olanzapine, Tricyclic Antidepressants (TCAs), Antipsychotics such as Haloperidol and Clozapine, Anticonvulsants such as Phenytoin and Carbamazepine within 2 weeks prior to starting the study.
9. Patients currently in foster care.

10. Patients currently receiving psychotherapy.

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

11. Patients with a past diagnosis of Bipolar Disorder, as determined by medical chart and medical history review by the site director and PI OR Patients who score ≥18 on the Parent General Behavior Inventory-10-Item Mania Scale (PGBI-10M) (possible range 0-30, higher scores representing an increased likelihood of diagnosis).
12. Patients with a current/active psychotic diagnosis (schizophrenia, schizoaffective, schizophreniform, psychosis not otherwise specified (NOS), or depression with psychotic features), as determined by medical chart and medical history review by the site director and PI.