Effects of Sertraline on Brain Connectivity in Adolescents With OCD

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2017-01-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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OCD

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Children with OCD

Children with obsessive compulsive disorder, not currently on medication for OCD

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

Impact of sertraline on functional brain connectivity

Healthy Control Children

Children without obsessive compulsive disorder

Group Type ACTIVE_COMPARATOR

No Intervention

Intervention Type OTHER

Healthy control non-intervention

Interventions

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Sertraline

Impact of sertraline on functional brain connectivity

Intervention Type DRUG

No Intervention

Healthy control non-intervention

Intervention Type OTHER

Other Intervention Names

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Zoloft

Eligibility Criteria

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Inclusion Criteria

* 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

* Healthy 8-17 year olds

Exclusion Criteria

* 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

* No psychiatric diagnoses
* No immediate family history of OCD

Minimum Eligible Age

8 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes