We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01160588
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Social Phobia Generalized Anxiety Disorder Separation Anxiety Disorder Drug: Sertraline Phase 4

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 Design

Study Type : Observational
Actual Enrollment : 156 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents
Study Start Date : July 2010
Primary Completion Date : March 2015
Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Groups and Cohorts

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 Name: 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).


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
saliva

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160588


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: K. Luan Phan, M.D. University of Michigan
More Information

Responsible Party: K. Luan Phan, Principal Investigator; Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01160588     History of Changes
Other Study ID Numbers: R01MH086517 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015

Keywords provided by K. Luan Phan, University of Michigan:
Anxiety
Social Phobia
Social Anxiety
Generalized Anxiety
Separation Anxiety

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Anxiety, Separation
Pathologic Processes
Mental Disorders
Phobic Disorders
Neurodevelopmental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs