Clinical Trial of Fluoxetine in Anxiety and Depression in Children, and Associated Brain Changes
Anxiety Disorders, Major Depressive Disorder
About this trial
This is an interventional treatment trial for Anxiety Disorders focused on measuring fMRI, Emotion, Normal Volunteers, Magnetic Resonance Imaging, CBT
Eligibility Criteria
INCLUSION CRITERIA: ALL JUVENILE SUBJECTS: Age: 8 - 17 (subjects who consent as 17- year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17- year- olds but do not turn 18). Consent: can give consent/assent (Parents will provide consent; minors will provide assent) IQ: all subjects will have IQ > 70 (Assessment relies on WASI) Language: all subjects will speak English ALL ADULT SUBJECTS Age: 18-65 Consent: can give consent IQ: all subjects will have IQ>70 (Assessment relies on WASI) Language: all subjects will speak English ALL SUBJECTS WITH AN ANXIETY DISORDER Diagnosis: Current Diagnosis of Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder (Based on K-SADS (juveniles) or SCID (adults)) Symptom Severity: Clinically significant, ongoing anxiety symptoms Clinical Impairment: Clinically significant, ongoing distress or impairment from anxiety ALL SUBJECTS WITH A MOOD DISORDER Diagnosis: Current Diagnosis of Major Depression (Based on K-SADS (juveniles) or SCID (adults)) Clinical Impairment: Clinically significant, ongoing distress or impairment from depressive symptoms Symptom Severity: Clinically significant, ongoing depressive symptoms ALL PREVIOUSLY ENROLLED ADOLESCENT PATIENTS, HEALTHY VOLUNTEERS, AND HEALTHY VOLUNTEERS TURNED PATIENTS Diagnosis: Current Diagnosis of Social Phobia, Separation Anxiety, Generalized Anxiety Disorder, or Panic Disorder; No current diagnosis (Based on K-SADS (juveniles) or SCID (adults)) Clinical Impairment (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.) Symptom Severity (as applicable): Clinically significant, ongoing symptoms (This will be documented by clinician review with patients and their families during at least two visits with families.) 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 complete a medical history. 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. Current diagnoses Tourette s Disorder, OCD, post-traumatic distress disorder, conduct disorder Past or current history of mania, psychosis, or severe pervasive developmental disorder 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. NIMH employees and staff and their immediate family members will be excluded from the study per NIMH policy HEALTHY ADULT SUBJECTS Any current psychiatric diagnosis (Assessment relis on SCID)
Sites / Locations
- National Institutes of Health Clinical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Active
Control
Subjects in both treatment arms receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete either the active-intervention arm or the control invention arm. In these arms, either the active or control treatment is administered immediately before a CBT session.
Subjects in both treatment arms receive cognitive behavioral therapy (CBT) for a 12-week period. In the final eight weeks of the trial, the subjects complete either the active-intervention arm or the control invention arm. In these arms, either the active or control treatment is administered immediately before a CBT session.