Clinical trial NCT03584945: Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Official title: Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-compulsive Disorders and Symptoms in Children
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Columbia University
name: National Institute of Mental Health (NIMH)
First posted: 2018-07-12
Enrollment: 169
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Children ages 6-14 with OCD, obsessive compulsive symptoms, or healthy controls
Primary purpose: TREATMENT

Brief summary: This study will use magnetic resonance imaging (MRI) to assess the function and structure of overlapping task control circuits in children with a range of Obsessive-Compulsive symptoms (OCS). The functioning of task control circuits will be assessed using the well-validated Multisource interference task (MSIT). This study will also assess functional and anatomical connectivity within task control circuits in the same children, and determine whether disturbances in these overlapping circuits are associated with Obsessive-Compulsive Disorder (OCD) symptom severity. Behavioral measures will be administered to further assess regulatory, learning and memory functions. Children with OCD will then be offered a standard course of up to 12 cognitive behavioral therapy (CBT), either via remote video conference sessions or in person visits when clinically indicated, before scanning (along with age-and gender-matched control participants) in order to assess how these circuits may change with treatment. Children with subclinical OC symptoms will be offered referral for treatment on an as-needed basis. In addition, de-identified data may be used in the future to conduct secondary data analyses. As more about OC symptoms and neurobiological mechanisms of interest in the current study are understood, data may be used to answer questions beyond those described in this protocol. All study procedures will be conducted on-site at Columbia University/the New York State Psychiatric Institute (New York, NY) and the University of Michigan's outpatient Child and Adolescent Psychiatry (Ann Arbor, Michigan).

Detailed description: Recruitment is complete. U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume analysis of results from its two sites for results reporting after OHRP and the IRB has approved the resumption of research.

Eligibility criteria: Obsessive-Compulsive Disorder (OCD) patient group

INCLUSION:

1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnosis of OCD as the principal problem
2. Not on psychotropic medication and not receiving current psychotherapy for OCD
3. Written informed assent by the participants and consent by the parent
4. Participants and a parent/guardian must be able to read and understand English

EXCLUSION

1. DSM-5 current diagnosis of major depressive disorder, or substance/alcohol abuse
2. DSM-5 lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
3. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications (stable doses of stimulants or other types of ADHD medications - e.g. Guanfacine - are allowable for OCD subjects with comorbid attention deficit hyperactivity disorder following investigator review of medication; on day of study scan, subjects must be willing to refrain from taking medication until after scan is completed)
4. Active suicidal ideation
5. Females who are pregnant or nursing
6. Major medical or neurological problems
7. Presence of metallic device or dental braces
8. Intelligence Quotient (IQ)\<80
9. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
10. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
11. Individuals who have received a full course of CBT in the past
12. A positive pregnancy test
13. Positive urine screen for illicit drugs

Healthy controls

INCLUSION:

1. Written informed assent by the participants and consent by the parent
2. Participants and a parent/guardian must be able to read and understand English

EXCLUSION:

1. Any current or lifetime psychiatric diagnosis
2. Active suicidal ideation
3. Females who are pregnant or nursing
4. Major medical or neurological problems
5. Presence of metallic device or dental braces
6. IQ \<80
7. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
8. A positive pregnancy test
9. Positive urine screen for illicit drugs

Obsessive Compulsive Symptoms

INCLUSION:

1. Presence of obsession(s) and/or compulsion(s) but no current diagnosis of OCD (i.e.,\<1 hour/day, no more than mild interference or distress)
2. Not on psychotropic medication and not receiving current psychotherapy for OCD
3. Written informed assent by the participants and consent by the parent
4. Participants and a parent/guardian must be able to read and understand English

EXCLUSION:

1. DSM-5 current diagnosis of major depressive disorder, attention-deficit hyperactivity disorder, Tourette's/Tic Disorder, or substance/alcohol abuse
2. DSM-5 lifetime diagnosis of psychotic disorder, bipolar disorder, eating disorder, pervasive developmental disorder, or substance/alcohol abuse
3. Active suicidal ideation
4. Females who are pregnant or nursing
5. Major medical or neurological problems
6. Presence of metallic device or dental braces
7. IQ\<80
8. A current or past diagnosis of pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS)
9. Individuals who are currently receiving CBT, other forms of psychotherapy, or psychotropic medications
10. Individuals who have received a full course of CBT in the past
11. Positive urine screen for illicit drugs

Primary outcomes:
measure: Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task
timeFrame: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups); approximately 15-20 minutes
Secondary outcomes:
measure: Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits
timeFrame: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 10 minutes
measure: Child Yale-Brown Obsessive Compulsive Scale
timeFrame: up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 1 hour
measure: Obsessive Compulsive Inventory - Child Version (OCI-CV)
timeFrame: baseline assessment of all participants (OCD, subclinical OCS and HC)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
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.