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Completed

NCT Number: NCT02797808

Effects of Sertraline on Brain Connectivity in Adolescents With OCD

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

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Key information

Conditions

OCD

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sertraline

Drug

Impact of sertraline on functional brain connectivity

Other names: Zoloft

No intervention

Other

Healthy control non-intervention

Primary outcomes

  1. CY-BOCS Total Score at 12-weeks

    Time frame: 12 weeks

    The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) a clinician-rated semi-structured instrument assessing OCD severity over the previous 7 days in children ages 6 to 17 years. Items are scored from 0 (none) to 4 (extreme) and total score ranges from 0 to 40 with higher scores indicating greater impairment. All 19 items are rated, but only items 1-10 are used to determine the total score. The total CY-BOCS score is the sum of items 1-10; the obsession and compulsion subtotals are the sums of items 1-5 and 6-10, respectively. At this time, items 1A and 6A are not being used in the scoring. Items 17 (global severity) and 18 (global improvement) are adapted from the Clinical Global Impression Scale to provide measures of overall functional impairment associated with the presence of obsessive-compulsive symptoms.

  2. Longitudinal 2-Group Resting State Functional Conectivity (RSFC) Analyses

    Time frame: 12 weeks

    Participants had whole brain fMRI at baseline &12 weeks. Whole brain connectivity in 6 striatal ROIs was performed. Two-way mixed effects ANOVAs were performed with FEAT. Clusters were significant if p <.0042 based on .05/(6 ROIs x 2 tests/ROI). Mean z-score was found for each time point in each subject's connectivity map in each significant cluster. Within-group paired-sample t tests examined RSFC change over time in these metrics for each group. To investigate group X time interactions from the 2-way ANOVA, we compared mean z-scores within each significant cluster at baseline & 12 weeks. Resulting numbers represented striatal connectivity for each individual at each time point. Within group paired sample t-tests examined RSFC change over time for each group. Bonferroni correction was applied to alpha level (2-tailed, p<0.5/6 =.0083) for multiple testing. We do not have an a priori hypothesis as to whether increase or decrease in RSFC is a better outcome. Unit of measure is z-score.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Effects of Sertraline on Brain Connectivity in Adolescents With OCD (Obsessive-Compulsive Disorder)

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jun 13, 2016
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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