Trial record 16 of 2262 for:    ANXIETY

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
K. Luan Phan, University of Michigan
ClinicalTrials.gov Identifier:
NCT01160588
First received: July 9, 2010
Last updated: November 23, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Social Phobia
Generalized Anxiety Disorder
Separation Anxiety Disorder
Drug: Sertraline
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

saliva


Estimated Enrollment: 240
Study Start Date: July 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   7 Years to 19 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160588

Contacts
Contact: Kelly Kreger, M.S.W. 734-763-3134 kkreger@med.umich.edu
Contact: K. Luan Phan, M.D. 734-936-9275 luan@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: K. Luan Phan, M.D.         
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: K. Luan Phan, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: K. Luan Phan, Principal Investigator; Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01160588     History of Changes
Other Study ID Numbers: R01MH086517, R01MH086517
Study First Received: July 9, 2010
Last Updated: November 23, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Michigan:
Anxiety
Social Phobia
Social Anxiety
Generalized Anxiety
Separation Anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Anxiety, Separation
Mental Disorders
Phobic Disorders
Mental Disorders Diagnosed in Childhood
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014