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Home > "C" Clinical Trials Conditions > Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes  Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
For Condition: Healthy,Mood Disorder,Depression,Anxiety Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: This study will determine if fluoxetine (Prozac® (Registered Trademark)) is effective for treating anxiety or depression in children and adolescents. The study will also use functional magnetic resonance imaging (fMRI) to learn more about how the brain functions in children/adolescents taking this medication for anxiety or depression.
Details: Boys and girls ages 9 to 17 with anxiety and/or depression may be eligible for this outpatient treatment study. Participants will first meet with a psychiatrist or psychologist for 2 weekly sessions of talk therapy. Those who remain anxious or depressed after these 2 weeks can choose to receive treatment for 8 weeks with one of the following: 1) fluoxetine daily, 2) cognitive-behavioral therapy once a week, or 3) a double-blind, placebo-controlled trial. All patients will be seen by a doctor approximately weekly to talk and complete verbal and written exercises. Participants will be interviewed both individually and together with a parent to assess general mood, degree of nervousness, and behavior. Functional magnetic resonance imaging is performed before and after the 8-week study period. Those who have not improved by the end of the study will be offered other, non-research treatment for up to 3 months, and NIMH clinicians will help find aftercare. Those who improve with treatment continue therapy at NIMH until an outside physician can assume responsibility for monitoring medication. All procedures and medications associated with the research are provided at no cost to participants, and transportation expenses are reimbursed by NIMH.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: ELIGIBILITY CRITERIA: Children or adolescents between 9-17 years old with anxiety and/or depression Able to provide assent and parent is able to give informed consent. IQ greater than 70 Must not have any medical condition that increases risk for SSRI treatment No pregnancy No current use of any psychoactive substance (particularly substance abuse) No current suicidal ideation If attention deficit hyperactivity disorder (ADHD) is present it cannot be so severe as to require pharmacotherapy No current diagnoses of Tourette's Disorder, OCD, post-traumatic distress disorder, conduct disorder, or history of mania, psychosis, or pervasive developmental disorder. No 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.
Total Enrollment: 708
Location and Contact Information:
National Institute of Mental Health (NIMH) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 010192; 01-M-0192
Study Start Date: June 26, 2001
Record last reviewed: July 14, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00018057
Other Anxiety Disorder Studies:
1. Study of the Psychological Development of Children of Parents with and without Affective Disorders
2. Treatment of Mid-Life-Related Mood Disorders
3. Examination of Brain Serotonin Receptors in Patients with Mood Disorders
4. The Effects of Hormones in Postpartum Mood Disorders
5. Clinical Trial of Leuprolide Acetate for the Treatment of PMS
Related Studies:
Other Anxiety Disorder Clinical Trials
Other Maryland Clinical Trials
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Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
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