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View Clinical Trial (Medical Research Study)
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Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes - NCT00018057-10016 (Clinical Trial 113508)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy113508.aspx
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| City: |
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New York |
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State:
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NY |
| Zip Code: |
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10016 |
| Conditions: |
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Depression - Mood Disorder - Anxiety Disorder - Healthy |
| Purpose: |
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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
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| Study summary: |
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This protocol uses functional magnetic resonance imaging (fMRI) to examine neurocognitive
correlates of pediatric and adult mood and anxiety disorders. The primary goal of the
project is to document in pediatric anxiety disorders and major depression perturbations in
brain systems mediating attention biases, fear conditioning, emotional memory, and response
to various forms of motivational stimuli. As one secondary goal, the project measures the
relationship between these factors and treatment response to either fluoxetine, a specific
serotonin reuptake inhibitor (SSRI), cognitive behavioral therapy (CBT), or interpersonal
psychotherapy (IPT). Another secondary goal examines similar associations in adults.
A total of 630 children, adolescents, and adults will be recruited and comprehensively
studied. This will include 150 juveniles with only a current anxiety disorder, 60 juveniles
with current major depression, 150 juveniles with no psychiatric disorder, 60 adults with
major depression, 60 adults with an anxiety disorder, and 150 adults with no psychiatric
disorder. Subjects will be tested using fMRI paradigms designed to examine brain regions
engaged when processing motivationally salient stimuli, as assessed during attention,
memory, social interaction, reward, and fear-conditioning paradigms. After these initial
fMRI tests, subjects with depression or an anxiety disorder receive treatment. Adolescent
subjects then will be re-tested after eight-weeks using only the attention, memory, and
conditioning paradigms.
Prior studies note that mood and anxiety disorders are associated with deficits in attention
and emotional memory. Prior imaging studies note that tasks requiring attention modulation,
emotional memory, social interchange, and fear conditioning engage brain regions previously
implicated in adult mood and anxiety disorders. These regions include most consistently the
amygdala and ventral prefrontal cortex. Moreover, imaging studies of reward function
implicate the striatum and prefrontal cortex in adult mood disorders. As a result, we
hypothesize that attention, memory, social interaction, reward, and conditioning paradigms
will engage the amygdala, ventral prefrontal cortex and striatum in both psychiatrically
healthy and impaired subjects. Moreover, we hypothesize that these healthy and
psychiatrically impaired groups will differ in the degree of engagement.
Prior studies suggest that SSRIs, CBT, and IPT effectively treat symptoms of mood and
anxiety disorders. Moreover, prior studies in adults also suggest that fMRI response
patterns predict response to these treatments. In the current protocol, juvenile subjects
will be treated for eight-weeks using either SSRIs, CBT, or IPT. Subjects also may elect to
receive attention-retraining as part of their treatment with one of these agents. A subset
of subjects will be re-tested with fMRI. We predict that pre-treatment abnormalities in
neural circuitry will predict response to treatment, such that increased amygdala and
prefrontal activation will occur in individuals who show the strongest response to
treatment. Moreover, we hypothesize that effective treatment will normalize abnormalities
in attention and emotional memory, as manifest in fMRI. |
| Criteria: |
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- INCLUSION CRITERIA:
ALL 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)
ALL 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.
ALL ADULT SUBJECTS:
Any current psychiatric diagnosis. Assessment relies on SCID.
SUBJECTS WITH AN ANXIETY DISORDER:
Current Major Depressive Disorder |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 15, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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