Effects of Sertraline on Brain Connectivity in Adolescents With OCD

University of Minnesota (UMN)

Status and phase: Completed; Phase 2; Phase 1

Conditions: OCD

Treatments: Other: No Intervention; Drug: Sertraline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02797808

5R21MH101395-02 (U.S. NIH Grant/Contract)

1105M99532

Details and patient eligibility

About

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

Full 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).

Enrollment: 41 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 2 patient groups

Children with OCD

Experimental group

Description:

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

Treatment:

Drug: Sertraline

Healthy Control Children

Active Comparator group

Description:

Children without obsessive compulsive disorder

Treatment:

Other: No Intervention