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Social Phobia | Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents

Social Phobia research study

What is the primary objective of this study?

This study will attempt to identify gene and brain activity markers that predict whether children and adolescents with anxiety disorders will respond to selective serotonin reuptake inhibitor medications or Cognitive Behavioral Therapy (CBT).

Who is eligible to participate?

Inclusion Criteria: For anxiety disorder group: - 7-19 years of age - Current diagnosis of social anxiety disorder, generalized anxiety disorder and/or separation anxiety disorder - Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing For healthy control group: - 7-19 years of age - Never been diagnosed with either Axis I or Axis II mental disorders - Physically healthy, as confirmed by comprehensive medical history, physical exam, and laboratory testing Exclusion Criteria for all: - Clinically significant medical or neurologic condition - Life history of bipolar disorder, schizophrenia, mental retardation, or pervasive developmental disorder or current alcohol/drug abuse or dependence - Severe current depression, as indicated by the Child Depression Inventory, or by the clinical decision of the rater or doctor - Current suicidal ideation - Treatment with psychotropic/psychoactive medications in the past two weeks (4 weeks for fluoxetine and monoamine oxidase inhibitors) before screening - Positive urine drug screen results - Pregnancy - Clinically significant medical condition that interferes with metabolism of sertraline - Multiple drug allergies - Prior failure of response to sertraline for anxiety, as defined by adequate duration to achieve a clinical response - Refusing to attend school because of anxiety Additional exclusion criteria for the functional MRI studies: - Presence of ferrous-containing metals within the body, such as aneurysm clips, shrapnel, or retained particles - Claustrophobia

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Social Phobia

Generalized Anxiety Disorder

Separation Anxiety Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:SertralineOral sertraline will be started at 25 mg/day, increasing on subsequent visits to 50, 75, 100, 125, 150, and 200mg/day) Unless adverse effects become problematic, the goal is for subjects to reach 200mg/day. Dosing of sertraline is flexible, based on tolerance (absence of side effects) and clinical response.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Sertraline treatmentParticipants with Generalized Anxiety Disorder, and/or Social Anxiety Disorder, and/or Separation Anxiety Disorder will undergo MRI scanning, EEG's, and sertraline treatment.

Healthy ControlsHealthy control participants will undergo MRI scanning and EEG's.

Cognitive Behavioral TherapyParticipants with Generalized Anxiety Disorder, and/or Social Anxiety Disorder, and/or Separation Anxiety Disorder will undergo MRI scanning, EEG's, and talk therapy (CBT).

Study Status

Completed

Start Date: July 2010

Completed Date: March 2015

Phase:

Type: Observational

Design:

Primary Outcome: Clinical Global Impression (CGI) Scale

Secondary Outcome: Liebowitz Social Anxiety Scale (LSAS)

Study sponsors, principal investigator, and references

Principal Investigator: K. Luan Phan, M.D.

Lead Sponsor: University of Michigan

Collaborator: National Institute of Mental Health (NIMH)

More information:https://clinicaltrials.gov/show/NCT01160588

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