Generalized Anxiety Disorder Clinical Trial
Official title:
Brain Markers of Anxiety Disorders and SSRI/CBT Treatment in Children and Adolescents
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).
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.
;
Observational Model: Case Control, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03420456 -
Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study
|
N/A | |
| Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
| Withdrawn |
NCT02382224 -
Worry Exposure for Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT02306356 -
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
|
N/A | |
| Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
| Completed |
NCT01958788 -
Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT01681329 -
Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT01337713 -
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
|
N/A | |
| Completed |
NCT01342120 -
PHARMO Institute Seroquel Safety Study
|
N/A | |
| Completed |
NCT01201967 -
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
|
Phase 4 | |
| Completed |
NCT01971203 -
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
|
N/A | |
| Completed |
NCT00961298 -
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
|
Phase 4 | |
| Completed |
NCT01203293 -
Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
|
Phase 1 | |
| Completed |
NCT00744627 -
Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.
|
Phase 3 | |
| Terminated |
NCT01244711 -
Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
|
Phase 4 | |
| Completed |
NCT00711737 -
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
|
N/A | |
| Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
| Completed |
NCT00515242 -
Therapeutic Massage for Generalized Anxiety Disorder
|
Phase 1/Phase 2 | |
| Completed |
NCT00537615 -
An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT00368745 -
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
|
Phase 3 |