Protocol Details

Fluoxetine's Effects on Attention and Emotional Memory in Anxious and Depressed Youth and Adults

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number	01-M-0192
Sponsoring Institute	National Institute of Mental Health (NIMH)
Recruitment Detail	Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 8 Max Age: 40
Referral Letter Required	No
Population Exclusion(s)	None
Special Instructions	Call the CORE phone number for more information: 301-496-5645
Keywords	fMRI; SSRI; Neuropsychological; Evaluative Learning; Adolescent; Normal Volunteers; Magnetic Resonance Imaging; CBT; IPT; Anxiety
Recruitment Keyword(s)	Adolescent; Anxiety Disorder; Mood Disorder; Depression; Healthy Volunteer; Normal Control
Condition(s)	Depression; Mood Disorder; Anxiety Disorder; Healthy
Investigational Drug(s)	None
Investigational Device(s)	None
Intervention(s)	None
Supporting Site	National Institute of Mental Health

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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Eligibility

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

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Citations:

Vulnerability factors among children at risk for anxiety disorders

Behavioral inhibition in childood: a risk factor for anxiety disorders

The risk for early-adulthood anxiety and depressive disorders in adolescents with anxiety and depressive disorders

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Contacts:

Principal Investigator	Referral Contact	For more information http://clinicalstudies.info.nih.gov.
Daniel S. Pine, M.D. National Institute of Mental Health (NIMH) National Institutes of Health Building 15K Room 113 1K North Drive Bethesda, Maryland 20892 (301) 594-2894 grillonc@mail.nih.gov	Daniel S. Pine, M.D. National Institute of Mental Health (NIMH) National Institutes of Health Building 15K Room 113 1K North Drive Bethesda, Maryland 20892 (301) 594-2894 grillonc@mail.nih.gov	Rista Plate National Institutes of Health Building 10 Room B1D43K7 10 Center Drive Bethesda, Maryland 20892 (301) 451-6817 platerc@mail.nih.gov

Clinical Trials Number:

NCT00018057

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