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

NCT01160588 | Completed DMC

• 1 other identifier: R01MH086517
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Social Phobia; Generalized Anxiety Disorder; Separation Anxiety Disorder

Keywords

Anxiety; Social Phobia; Social Anxiety; Generalized Anxiety; Separation Anxiety

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression (CGI) Scale

  Change from Baseline in CGI score at 12 or 16 weeks after treatment SSRI or CBT, respectively). Measured before treatment, at each treatment study visits, and after treatment

Secondary Outcomes (1)

• Liebowitz Social Anxiety Scale (LSAS)

  Change from Baseline in LSAS score at 12 or 16 weeks after treatment SSRI or CBT, respectively). Measured before treatment, at each treatment study visits, and after treatment

Study Arms (3)

Sertraline treatment

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

Drug: Sertraline

Healthy Controls

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

Cognitive Behavioral Therapy

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

Interventions

Sertraline DRUG

Oral 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.

Also known as: Zoloft

Sertraline treatment

Eligibility Criteria

• Age: 7 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with one or more of the following anxiety disorders (diagnosed by our study): Generalized Anxiety Disorder, Social Anxiety Disorder, Separation Anxiety Disorder.

You may qualify if:

• For anxiety disorder group:
• 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:
• 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

You may not qualify if:

• 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
• Presence of ferrous-containing metals within the body, such as aneurysm clips, shrapnel, or retained particles
• Claustrophobia

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Phobia, Social; Generalized Anxiety Disorder; Anxiety, Separation; Anxiety Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• K. Luan Phan, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator; Associate Professor

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 12, 2010
• Study Start: July 1, 2010
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)