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

May 26, 2015 updated by: K. Luan Phan, University of Michigan
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anxiety disorders are common and highly disabling conditions of children and adolescence that often do not remit, and increase the risk of depression, anxiety, substance abuse, and suicide in adulthood. Available treatments are only modestly successful. When they are effective, however, early treatment of anxiety disorders can reduce subsequent morbidity.

This study will examine variations in genetics and brain reactivity among children and adolescents who do and do not respond to SSRIs and Cognitive Behavioral Therapy. Through this, the study will identify neurological and genetic biomarkers that can predict responsiveness to SSRI/CBT treatment in those with anxiety disorders.

For SSRI/medication treatment arm:

Although selective serotonin reuptake inhibitors (SSRI) are medications widely prescribed for children and adolescents with anxiety disorders, little is known about the neurobiological factors that predict which patients respond to treatment. Current theory suggests that neurological functioning and genetics may influence a patient's response to treatment.

Participation in this study will last approximately 14 weeks. Both healthy participants and participants with anxiety disorders will be recruited to participate. All participants will complete similar study visits at entry, within 2 weeks of entry, and 12 weeks after that. The first visit, which will occur at study entry, will include screening questionnaires, an interview with research staff, a medical screening, and collection of saliva samples for genotyping. The second visit and the last visit, which will be separated by 12 weeks, will involve MRI scans and behavioral tasks to be conducted inside and outside the MRI scanner. Over the 12 weeks between MRI scanning sessions, participants with anxiety disorders will take sertraline, a common SSRI, on a daily basis. They will also attend nine additional visits during this time to complete assessments of their symptoms. These visits will occur 0, 1, 2, 3, 4, 6, 8, 10 and 12 weeks after the first scan. Participants with anxiety disorders will therefore be completing a symptom assessment, MRI scans, and behavioral tasks all on the final visit, 12 weeks after the second visit. In addition, participants will complete tasks while connected to an Electroencephalography(EEG) machine before and after the 12 weeks of treatment, and will have the option of additional EEG's at weeks 2, 4, and 8.

For CBT arm:

Participation in this study will last 16 weeks. All participants will complete similar study visits at entry, within 2 weeks of entry, and approximately 16 weeks after that. The first visit, which will occur at study entry, will include screening questionnaires, an interview with research staff, a medical screening, and collection of saliva samples for genotyping. The second visit and the last visit, which will be separated by approximately 16 weeks, will involve MRI scans and behavioral tasks to be conducted inside and outside the MRI scanner. Over the 16 weeks between MRI scanning sessions, participants with anxiety disorders will participate in type of talk therapy--Cognitive Behavioral Therapy--on a weekly basis. In addition, participants will complete tasks while connected to an Electroencephalography(EEG)machine before and after the 16 weeks of treatment, and will have the option of additional EEG's at weeks 2, 4, and 8.

Study Type

Observational

Enrollment (Actual)

156

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • Zoloft
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression (CGI) Scale
Time Frame: 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
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 Outcome Measures

Outcome Measure
Time Frame
Liebowitz Social Anxiety Scale (LSAS)
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: K. Luan Phan, M.D., University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

July 9, 2010

First Submitted That Met QC Criteria

July 9, 2010

First Posted (ESTIMATE)

July 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH086517 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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