Obsessive-compulsive Disorders and Symptoms in Children Clinical Trial
Official title:
Task Control Circuit Targets for Obsessive Compulsive Behaviors in Children
| Verified date | August 2023 |
| Source | University of Michigan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 169 |
| Est. completion date | June 3, 2023 |
| Est. primary completion date | June 3, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 6 Years to 14 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Michigan | Ann Arbor | Michigan |
| United States | New York State Psychiatric Institute | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| University of Michigan | Columbia University, National Institute of Mental Health (NIMH) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Blood oxygen-level dependent (BOLD) functional MRI signal during a cognitive conflict task | up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups); approximately 15-20 minutes | ||
| Secondary | Blood oxygen-level dependent (BOLD) functional connectivity MRI of task control circuits | up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 10 minutes | ||
| Secondary | Child Yale-Brown Obsessive Compulsive Scale | Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) is scored on a scale of 0 to 40, with 40 being the most severe. | up to 16 weeks after baseline (following 12 weeks of therapy for intervention groups);approximately 1 hour | |
| Secondary | Obsessive Compulsive Inventory - Child Version (OCI-CV) | Self-report assessment of obsessive compulsive symptoms, non-clinical to clinical range. | baseline assessment of all participants (OCD, subclinical OCS and HC) |