Effects of Sertraline on Brain Connectivity in Adolescents With OCD
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|ClinicalTrials.gov Identifier: NCT02797808|
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|OCD||Drug: Sertraline Other: No Intervention||Phase 1 Phase 2|
To examine FSTC using advanced multi-modal imaging techniques, including resting-state functional magnetic resonance imaging (R-fMRI) and high angular resolution diffusion imaging (HARDI), in 25 medication-free adolescents youths with OCD (ages 8-17) in comparison with 25 matched healthy controls.
Hypotheses: (A) Based on the pilot data, adolescents youths with OCD will show lower functional connectivity in FSTC at baseline when compared with controls, and , lower functional connectivity in FSTC will correlate with greater severity on CY-BOCS. (B) Adolescents Youths with OCD will also show abnormalities in structural connectivity in FSTC at baseline when compared with controls, and structural and functional connectivity will be related. (C) The investigators will explore relations between OCD dimensions and functional connectivity measures, and predict that the repeating/ordering dimension will correlate with orbitofrontal cortex (OFC) connections, hoarding will correlate with rostral anterior cingulate cortex (ACC) connections, and forbidden thoughts will correlate with caudal ACC connections.
To investigate how sertraline impacts functional connectivity in FSTC in adolescents with OCD.
Hypothesis: After 12 weeks of sertraline treatment, functional connectivity measures within FSTC for the OCD group will (on average) increase compared to baseline and will no longer be significantly different when compared with controls. Non-responders may show a different pattern (i.e. failure to show these changes).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects of Sertraline on Brain Connectivity in Adolescents With OCD (Obsessive-Compulsive Disorder)|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||January 31, 2017|
|Actual Study Completion Date :||January 31, 2017|
Impact of sertraline on functional brain connectivity
|Active Comparator: Healthy Controls||
Other: No Intervention
Healthy control non-intervention
- Change in brain connectivity [ Time Frame: Baseline, 12 weeks ]MRI of brain
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): NCT02797808
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55454|
|Principal Investigator:||Gail A Bernstein, MD||University of Minnesota - Clinical and Translational Science Institute|