Clinical trial NCT02421315: Overlapping Neural Circuits in Pediatric OCD
Official title: Overlapping Neural Circuits Implicated in Pediatric OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive Compulsive Disorder
Keywords: OCD
Functional Magnetic Resonance Imaging (fMRI)
Magnetic Resonance Imaging (MRI)
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2015-04-20
Enrollment: 55
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to examine the brain functioning of children and adolescent with OCD before and after treatment with Exposure and Response Prevention (EXRP) therapy.

Detailed description: The capacity to coordinate thoughts and actions to execute goal-directed behaviors (cognitive control) and the capacity to anticipate, respond to, and learn from reward (reward processing) are key processes for human behavior. Dysfunction in these processes has been hypothesized to contribute to repetitive thoughts and behaviors in many disorders, including obsessive-compulsive disorder (OCD), Tourette Syndrome (TS), and eating disorders. The investigators will use multimodal imaging to investigate neural circuits that support cognitive control and reward processing, using pediatric OCD as a model system. The short-term goal is to clarify how circuit-based abnormalities contribute to repetitive thoughts/behaviors; these data will inform future trans-diagnostic studies. The long-term goal is to identify control and reward circuit-abnormalities as targets for new trans-diagnostic treatments.

Eligibility criteria: Patient Inclusion Criteria:

* Participants must be 5-17 at the time of consent
* Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Diagnosis of OCD as the principal problem
* Not on psychotropic medication and not receiving current psychotherapy for OCD
* Written informed assent by the participants (8 and older) and consent by the parent
* Participants and a parent/guardian must be able to read and understand English

Patient Exclusion Criteria:

* DSM-IV current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
* DSM-IV lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
* Active suicidal ideation
* Females who are pregnant or nursing
* Major medical or neurological problems
* Presence of metallic device or dental braces
* IQ\<80
* A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
* Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
* Individuals who have received a full course of CBT in the past
* A positive pregnancy test
* Positive urine screen for illicit drugs
* Inability of participant or parent/guardian to read or understand English

Healthy Control Inclusion Criteria:

* Participants must be 5-17 at the time of consent
* Written informed assent by the participants (8 and older) and consent by the parent
* Participants and a parent/guardian must be able to read and understand English

Healthy Control Exclusion Criteria:

* Any current or lifetime psychiatric diagnosis
* Active suicidal ideation
* Females who are pregnant or nursing
* Major medical or neurological problems
* Presence of metallic device or dental braces
* IQ\<80
* A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
* A positive pregnancy test
* Positive urine screen for illicit drugs
* Inability of participant or parent/guardian to read or understand English

Primary outcomes:
measure: Brain Activation Associated With the Resolution of Cognitive Conflict
timeFrame: single time point: baseline
Secondary outcomes:
measure: Functional Connectivity
timeFrame: single time point: Baseline
measure: Brain Gray Matter Thickness
timeFrame: Single time point: Baseline
measure: Structural Connectivity (Streamline Counts)
timeFrame: Single time point (baseline)
Other outcomes:
Locations:
city: New York
country: United States
facility: NY State Psychiatric Institute
state: New York
Study officials:
affiliation: New York Psychiatric Institute
name: Rachel Marsh, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang Z, Fontaine M, Cyr M, Rynn MA, Simpson HB, Marsh R, Pagliaccio D. Subcortical shape in pediatric and adult obsessive-compulsive disorder. Depress Anxiety. 2022 Jun;39(6):504-514. doi: 10.1002/da.23261. Epub 2022 Apr 29.
citation: Lv D, Ou Y, Wang Y, Ma J, Zhan C, Yang R, Chen Y, Shang T, Jia C, Sun L, Zhang G, Sun Z, Li J, Wang X, Guo W, Li P. Altered Functional Connectivity Strength at Rest in Medication-Free Obsessive-Compulsive Disorder. Neural Plast. 2021 Sep 8;2021:3741104. doi: 10.1155/2021/3741104. eCollection 2021.
citation: Cyr M, Pagliaccio D, Yanes-Lukin P, Fontaine M, Rynn MA, Marsh R. Altered network connectivity predicts response to cognitive-behavioral therapy in pediatric obsessive-compulsive disorder. Neuropsychopharmacology. 2020 Jun;45(7):1232-1240. doi: 10.1038/s41386-020-0613-3. Epub 2020 Jan 17.
citation: Pagliaccio D, Cha J, He X, Cyr M, Yanes-Lukin P, Goldberg P, Fontaine M, Rynn MA, Marsh R. Structural neural markers of response to cognitive behavioral therapy in pediatric obsessive-compulsive disorder. J Child Psychol Psychiatry. 2020 Dec;61(12):1299-1308. doi: 10.1111/jcpp.13191. Epub 2019 Dec 31.