ClinicalTrials.Veeva

Menu

Overlapping Neural Circuits in Pediatric OCD

N

New York State Psychiatric Institute

Status

Completed

Conditions

Obsessive Compulsive Disorder

Treatments

Behavioral: CBT treatment for OCD based on Exposure & Response Prevention (EX/RP) and when indicated medication treatment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02421315
R21MH101441 (U.S. NIH Grant/Contract)
7006

Details and patient eligibility

About

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.

Full 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.

Enrollment

55 patients

Sex

All

Ages

5 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

55 participants in 2 patient groups

Participants With Obsessive-compulsive Disorder (OCD)
Experimental group
Description:
Children and adolescents who meet DSM-IV diagnostic criteria for OCD and had clinically significant obsessive-compulsive symptoms (CY-BOCS score>15). Comorbid anxiety disorders, but no other lifetime psychiatric diagnoses, were permitted in the OCD group as long as OCD was the primary diagnosis. Participants were unmedicated and had not received a full course of CBT with exposure and response prevention for OCD prior to their participation in the study. Following baseline assessment and scan, patients with OCD underwent a course of manualized treatment of CBT with E/RP adapted for pediatric OCD delivered by a licensed clinical psychologist or advanced supervised graduate student in clinical psychology at the NYSPI.
Treatment:
Behavioral: CBT treatment for OCD based on Exposure & Response Prevention (EX/RP) and when indicated medication treatment
Healthy Control (HC) Participants
No Intervention group
Description:
Healthy control (HC) participants matched on age and sex with the OCD group. HC participants had no lifetime psychiatric disorders. HC participants were assessed and scanned at baseline and again after 12-16 weeks.

Trial documents
1

Trial contacts and locations

1

Loading...

Central trial contact

Sarah Pieper, B.A.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems