Effects of Sertraline on Brain Connectivity in Adolescents With OCD

NCT02797808 | Completed Phase 1 Results DMC

• 2 other identifiers: 1105M995325R21MH101395-02
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

OCD

Keywords

OCD

Outcome Measures

Primary Outcomes (2)

• CY-BOCS Total Score at 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.

  12 weeks

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

  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.

  12 weeks

Study Arms (2)

Children with OCD

EXPERIMENTAL

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

Drug: Sertraline

Healthy Control Children

ACTIVE COMPARATOR

Children without obsessive compulsive disorder

Other: No Intervention

Interventions

Sertraline DRUG

Impact of sertraline on functional brain connectivity

Also known as: Zoloft

Children with OCD

No Intervention OTHER

Healthy control non-intervention

Healthy Control Children

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Healthy 8-17 year olds
• No psychiatric diagnoses
• No immediate family history of OCD

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (2)

• Bernstein GA, Mueller BA, Schreiner MW, Campbell SM, Regan EK, Nelson PM, Houri AK, Lee SS, Zagoloff AD, Lim KO, Yacoub ES, Cullen KR. Abnormal striatal resting-state functional connectivity in adolescents with obsessive-compulsive disorder. Psychiatry Res Neuroimaging. 2016 Jan 30;247:49-56. doi: 10.1016/j.pscychresns.2015.11.002. Epub 2015 Nov 19.

  PMID: 26674413 RESULT

• Bernstein GA, Cullen KR, Harris EC, Conelea CA, Zagoloff AD, Carstedt PA, Lee SS, Mueller BA. Sertraline Effects on Striatal Resting-State Functional Connectivity in Youth With Obsessive-Compulsive Disorder: A Pilot Study. J Am Acad Child Adolesc Psychiatry. 2019 May;58(5):486-495. doi: 10.1016/j.jaac.2018.07.897. Epub 2018 Oct 30.

  PMID: 30768407 DERIVED

MeSH Terms

Interventions

Sertraline

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Gail Bernstein
• Organization: University of Minnesota

berns001@umn.edu

612-625-1632

Study Officials

• Gail A Bernstein, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2016
• First Posted: June 13, 2016
• Study Start: August 1, 2013
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)