N/A
N=55
Overlapping Neural Circuits in Pediatric OCD
Obsessive Compulsive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02421315 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Brain Activation Associated With the Resolution of Cognitive Conflict — .7; .59 Arbitrary units — p=0.0585
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBT treatment for OCD based on Exposure & Response Prevention (EX/RP) and when indicated medication treatment (Behavioral)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Activation Associated With the Resolution of Cognitive Conflict |
.7; .59 | 0.0585 |
| SECONDARY Functional Connectivity |
-0.312768356; 0.182360856 | .037 sig |
| SECONDARY Brain Gray Matter Thickness |
3; 2.89 | 0.0464 sig |
| SECONDARY Structural Connectivity (Streamline Counts) |
227.688; 328.224 | <0.025 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT02421315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.