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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The investigators will examine how treatment with sertraline for 12 weeks impacts frontal-striatal-thalamic circuitry (FSTC) in this OCD sample.

Condition or disease Intervention/treatment Phase
OCD Drug: Sertraline Other: No Intervention Phase 1 Phase 2

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OCD Drug: Sertraline
Impact of sertraline on functional brain connectivity

Active Comparator: Healthy Controls Other: No Intervention
Healthy control non-intervention




Primary Outcome Measures :
  1. Change in brain connectivity [ Time Frame: Baseline, 12 weeks ]
    MRI of brain



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (OCD):

  • OCD as the primary Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) diagnosis based on the Anxiety Disorders Interview Schedule (ADIS) for DSM-IV, Child Version
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) score of greater than 15

Exclusion Criteria (OCD):

  • lifetime diagnosis of bipolar disorder, schizophrenia, or substance abuse/dependence on ADIS
  • Intelligence Quotient (IQ) < 80 on Wechsler Abbreviated Scales of Intelligence (WASI)
  • positive urine drug screen
  • MRI-incompatible features (e.g., metal implants, claustrophobia)
  • current or recent trial of psychotropic medication (within the past 4 8 weeks or past 6 12 weeks for fluoxetine)
  • non-response in > 2 selective serotonin reuptake inhibitor (SSRI) trials of adequate dose/duration
  • positive pregnancy test
  • history of seizure disorder or serious head injury

Inclusion Criteria (Controls):

  • Healthy 8-17 year olds

Exclusion criteria (controls):

  • No psychiatric diagnoses
  • No immediate family history of OCD

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): NCT02797808


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Gail A Bernstein, MD University of Minnesota - Clinical and Translational Science Institute

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02797808     History of Changes
Other Study ID Numbers: 1105M99532
5R21MH101395-02 ( U.S. NIH Grant/Contract )
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
OCD

Additional relevant MeSH terms:
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Obsessive-Compulsive Disorder
Anxiety Disorders
Mental 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