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

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ClinicalTrials.gov Identifier: NCT01160588
Recruitment Status : Completed
First Posted : July 12, 2010
Last Update Posted : May 27, 2015
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
K. Luan Phan, University of Michigan

Tracking Information
First Submitted Date July 9, 2010
First Posted Date July 12, 2010
Last Update Posted Date May 27, 2015
Study Start Date July 2010
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 23, 2011)
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 ]
Original Primary Outcome Measures
 (submitted: July 9, 2010)
Clinical Global Impression (CGI) Scale [ Time Frame: Measured before treatment, at nine treatment study visits, and 12 weeks after starting treatment ]
Change History Complete list of historical versions of study NCT01160588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 23, 2011)
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 ]
Original Secondary Outcome Measures
 (submitted: July 9, 2010)
Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Measured before treatment, at nine treatment study visits, and 12 weeks after starting treatment ]
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents
Official Title Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents
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).
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
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
saliva
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.
Condition
  • Social Phobia
  • Generalized Anxiety Disorder
  • Separation Anxiety Disorder
Intervention 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
Study Groups/Cohorts
  • 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.
    Intervention: 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 26, 2015)
156
Original Estimated Enrollment
 (submitted: July 9, 2010)
160
Actual Study Completion Date March 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 7 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01160588
Other Study ID Numbers R01MH086517( U.S. NIH Grant/Contract )
R01MH086517 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party K. Luan Phan, University of Michigan
Study Sponsor University of Michigan
Collaborators National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: K. Luan Phan, M.D. University of Michigan
PRS Account University of Michigan
Verification Date May 2015