Anxiety Disorders (Pediatric) Research Study

This study uses functional magnetic resonance imaging (fMRI) to learn how the brain functions in adolescents receiving fluoxetine (Prozac) or cognitive behavioral therapy (CBT) for anxiety or depression in children/adolescents. All participants will receive interviews to assess how they are doing in general, including his or her general mood, degree of nervousness and behavior. Each participant and one of his or her parents will be interviewed separately and together.

All those enrolled in the study will have a physical examination. They will undergo tests involving problem-solving and memory and perform tasks that involve looking at pictures, remembering things, testing reaction times, and making simple choices. Participants with anxiety or depression will first meet with a psychiatrist or psychologist for two weekly sessions of talk therapy.

Those who remain anxious or depressed after these 2 weeks will have the 3 options based on their choice: 1) treatment with fluoxetine daily for 8 weeks 2) cognitive-behavioral therapy (a talk therapy) once a week for 8 weeks 3) a random assignment (50% chance) to either placebo or fluoxetine for 8 weeks. All participants will be seen approximately weekly for 8 weeks by a doctor to talk and complete verbal and written exercises. Blood samples will be drawn for laboratory tests before drug treatment and after it ends. Those who have not improved by the end of the study will be offered other treatment for 1 to 3 months, and the clinicians will help with finding subsequent aftercare. Those who improve with treatment will continue therapy at NIH until an outside physician is able to assume responsibility for monitoring medication.

Organization: 
NIMH
Principal Investigator: 
Daniel S. Pine, MD; 301-594-9960, Daniel.Pine@nih.hhs.gov
Eligibility Criteria: 

JUVENILE SUBJECTS

Age: 8 to 17

Consent: Can give consent/assent. (Parents will provide consent; minors will provide assent.)

IQ: All subjects will have IQ greater than 70 (Assessment relies on WASI)

SUBJECTS WITH AN ANXIETY DISORDER

Diagnosis: Current Diagnosis of Social Phobia, Separation Anxiety, or Generalized Anxiety Disorder (Based on K-SADS)

Symptom Severity: Score greater than 9 on PARS (This score was used to enroll subjects in previous trial demonstrating efficacy of an SSRI in pediatric anxiety.)

Clinical Impairment: CGAS less than 60

SUBJECTS WITH A MOOD DISORDER

Diagnosis: Current Diagnosis of Major Depression (Based on K-SADS (juveniles) or SCID (adults))

Clinical Impairment: CGAS less than 60 (juveniles) GAS less than 70 (adults)

Symptom Severity: CDRS Score greater than 39 (juveniles) (This score was used to enroll subjects in previous trials demonstrating efficacy of an SSRI in pediatric depression.)

ADULT SUBJECTS

Age: 20-40

Consent: Can give consent/assent.

IQ: All subjects will have IQ greater than 70. Assessment relies on WASI.

Exclusion Criteria: 

ALL SUBJECTS:

Any serious medical condition or condition that interferes with fMRI scanning, and for patients electing medication, any condition that increases risk of SSRI treatment. All patients will have complete physical examination. Healthy volunteer participants will be medication-free and have no current serious medical conditions, based on a review of their medical history.

Pregnancy

Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy. These factors could complicate treatment with an SSRI. No subject on medication will be accepted into the trial. Subjects will not be taken off of medications to enter the trial.

Current diagnoses: Tourette's, OCD, posttraumatic distress disorder, conduct disorder. These factors may be effected by SSRI treatment, influencing ability to detect effects on anxiety/depression

Past or current history of mania, psychosis, or pervasive developmental disorder. These factors may be effected by SSRI treatment, influencing ability to detect effects on anxiety/depression

Recent use of an SSRI: All subjects must have been free of any SSRI use for at least one month (fluoxetine six months) and must not have been treated with an SSRI for their current depressive episode. This is designed to exclude subjects who have failed a trial of an SSRI for their current episode of major depression.

HEALTHY ADULT SUBJECTS

Any current psychiatric diagnosis. Assessment relies on SCID.

SUBJECTS WITH AN ANXIETY DISORDER

Current Major Depressive Disorder

Contact: 
Allison M. Detloff, 301-451-6817, detloffa@mail.nih.gov
Location: 
Bethesda
State: 
Maryland
Study End Date: 
Tue, 2013-12-31

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