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Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes

Sponsored by National Institutes of Health Clinical Center (CC)

Phase Quota
Phase N/A

This study uses functional magnetic resonance imaging (fMRI) to learn how the brain functions in adolescents receiving fluoxetine (Prozac) cognitive behavioral therapy (CBT) or interpersonal therapy (IPT) for anxiety or depression in children/adolescents. All participants will receive interviews to assess how they are doing in general, including general mood, degree of nervousness and behavior. Each participant and one of his or her parents will be interviewed separately and together. Those electing the medication study will also receive a physical examination. Participants are asked to complete tasks involving problem-solving and memory 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 or interpersonal therapy (two kinds of talk therapy) once a week for 8 weeks 3) a random assignment (50% chance) to either placebo or fluoxetine for 8 weeks. During and after the 8 weeks of treatment, each participant will complete verbal and written symptom ratings. 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. FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645

Study Start Date: June 2001

Estimated Completion Date: Not specified

Specialties: Pediatrics: Child/Adolescent Psych Psychiatry: Child/Adolescent Psych,Mood Disorders,Neuropsych Sciences Neurology: Neuroradiology Radiology: MRI

Interventions

No interventions cited

Inclusion criteria

  • JUVENILE SUBJECTS:
    • Age: 8 - 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 Disorder, OCD, post-traumatic 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

Study Locations And Contact Information

  • National Institutes of Health Clinical Center 9000 Rockville Pike, Bethesda Maryland
    Contact: Stefanie Sequeira 301-402-8225 sequeirasl@mail.nih.gov
  • National Institutes of Health Clinical Center 9000 Rockville Pike, Bethesda Maryland

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