Obsessive-Compulsive DisorderNCT07570108
Precision Brain Mapping to Predict and Track Response to Exposure and Response Prevention Therapy in Youth With Obsessive-Compulsive Disorder
A study testing Exposure and Response Prevention Therapy, Clinical Assessments and Research MRI Sessions in people with Obsessive-Compulsive Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether brain scan results can help predict and track changes in obsessive-compulsive disorder, or OCD, symptoms in children and teens ages 10 to 17 who receive Exposure and Response Prevention therapy, also called ERP. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- Exposure and Response Prevention Therapy, Clinical Assessments and Research MRI Sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2031
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 10 to 17 years at the time of initial consent. Participants who reach age 18 while enrolled may remain in the study after completing the adult re-consent process; no new participants age 18 years or older will be recruited.
- DSM-5 diagnosis of obsessive-compulsive disorder, established through a clinical interview by a clinician.
- Parent or guardian able to provide informed consent and participant able to provide assent.
- Participant has sufficient English fluency to complete cognitive tasks and assessments. Parent or guardian English fluency is not required; interpreter support is available.
Who cannot join
- History or current evidence of a significant neurological disorder, including but not limited to seizure disorder, stroke, or traumatic brain injury with loss of consciousness.
- Any standard MRI contraindication identified during initial screening or on the MRI safety checklist, including but not limited to ferromagnetic implants, certain medical devices or metal fragments, severe claustrophobia, or pregnancy.
- Pregnancy at screening or pregnancy identified during study participation.
- Active suicidal ideation.
- Any psychiatric condition that, in the investigator's judgment, would interfere with study participation or data interpretation, including but not limited to psychotic disorders, bipolar disorders, severe neurodevelopmental disorders, intellectual disability, severe eating disorders, or recent significant substance use disorders within the past 6 months. Stable psychiatric comorbidities, including anxiety disorders, depressive disorders, ADHD, or tic disorders, are permitted if OCD remains the primary diagnosis.
- Any medical, psychiatric, or situational factor judged by the investigator as likely to compromise participant safety, adherence, or data integrity.
Trial locations and contacts
1 site in 1 country.
United States1 site
NewYork-Presbyterian Hospital / Weill Cornell Medicine
New York, New York, 10065
About this study
Official title: Precision Functional Mapping to Predict and Track ERP Response in Pediatric Obsessive-Compulsive Disorder: A Longitudinal fMRI Study
The goal of this clinical trial is to learn whether brain scan results can help predict and track changes in obsessive-compulsive disorder, or OCD, symptoms in children and teens ages 10 to 17 who receive Exposure and Response Prevention therapy, also called ERP. ERP is a type of therapy in which participants practice facing OCD-related fears while resisting rituals or compulsions.
The main question this study aims to answer is:
Read more
Can each participant's pattern of brain connections, measured with functional MRI brain scans, help predict and track weekly changes in OCD symptoms during and after a 14-week course of ERP, including during planned monthly booster sessions and additional booster sessions offered if symptoms worsen?
All participants will receive ERP. There is no placebo and no comparison group.
Participants will:
- Complete screening, consent or assent, interviews, questionnaires, and MRI safety checks
- Receive 14 weekly ERP sessions
- Complete OCD symptom assessments and functional MRI brain scans before, during, and after ERP
- Receive planned monthly ERP booster sessions after the 14 weekly sessions
- Receive additional brief ERP booster sessions if OCD symptoms worsen during follow-up
- Take part for up to about 62 weeks
Read the detailed description
This study examines whether individualized brain-connectivity measures obtained with repeated functional magnetic resonance imaging can help predict and track symptom change during exposure and response prevention, an evidence-based cognitive-behavioral therapy for pediatric obsessive-compulsive disorder.
OCD is characterized by obsessions, compulsions, or both, and in youth it can substantially interfere with school, family life, social development, and daily functioning. Although ERP and serotonin reuptake inhibitor medications are standard treatments for pediatric OCD, clinical outcomes vary. Some youth respond robustly, while others have partial improvement, persistent residual symptoms, or symptom recurrence after initial gains. Current clinical practice lacks individualized biological markers that can track treatment response over time or help identify which patients may require more intensive or alternative intervention strategies.
The scientific rationale for this study is that OCD symptoms have been linked to dysfunction in cortico-striato-thalamo-cortical brain circuits, including orbitofrontal cortex and striatal regions. However, these circuits vary across individuals, and group-average neuroimaging findings have not yet yielded clinically useful biomarkers for individual patients. Precision functional mapping uses repeated fMRI scans from the same person to generate individualized estimates of functional brain networks. By pairing ERP with longitudinal clinical assessment and repeated neuroimaging, this study will evaluate whether participant-specific functional connectivity features, particularly resting-state functional connectivity between orbitofrontal cortex and ventral striatum, are associated with changes in OCD symptom severity over time.
The broader anticipated benefit is scientific: the study may help clarify how individualized brain-connectivity patterns change during ERP and how those changes relate to symptom trajectory, treatment response, and maintenance or recurrence of symptoms. Findings may inform future approaches to personalized pediatric OCD care, including earlier identification of youth who may benefit from treatment augmentation or alternative strategies.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- Exposure and Response Prevention Therapy, Clinical Assessments, Research MRI Sessions
- Keywords
- Obsessive-compulsive disorder, Pediatric obsessive-compulsive disorder, OCD, Pediatric OCD, Exposure and response prevention, ERP, Cognitive behavioral therapy, Functional magnetic resonance imaging, Resting-state functional connectivity, Precision functional mapping, Longitudinal neuroimaging, Treatment response biomarker
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and Response Prevention TherapyBehavioural
Also called Exposure and Response Prevention, ERP
Exposure and response prevention (ERP) is an evidence-based form of cognitive behavioral therapy for obsessive-compulsive disorder. ERP involves graded exposure to obsession-triggering cues while supporting participants in refraining from compulsive responses. In this study, participants receive 14 planned weekly ERP sessions of approximately 60 minutes each, followed by three scheduled monthly booster sessions and optional symptom-triggered booster sessions during the maintenance phase. ERP may be delivered in person or by HIPAA-compliant telehealth.
Clinical AssessmentsOther
Participants complete repeated clinical assessments according to the study schedule to evaluate obsessive-compulsive disorder symptom severity, symptom change, functioning, safety, and related clinical outcomes over time. Assessments may include clinician-administered ratings, participant-report measures, and other study outcome measures. These assessments are conducted for research and clinical monitoring purposes and are not intended as a therapeutic intervention.
Research MRI SessionsDiagnostic test
Participants complete research magnetic resonance imaging sessions at scheduled study time points to acquire structural and functional MRI data, including functional MRI measures used to evaluate brain connectivity over time. Imaging sessions are used to examine changes in brain circuitry in relation to obsessive-compulsive disorder symptoms and treatment course. These sessions are conducted for research measurement purposes and are not intended to provide clinical diagnosis or treatment.
| Study group | Role | What they receive |
|---|---|---|
| Exposure and Response Prevention Therapy | Experimental | Participants receive exposure and response prevention (ERP) therapy, an evidence-based form of cognitive behavioral therapy for obsessive-compulsive disorder. Participants also receive repeated clinical assessments and research MRI sessions. ERP consists of 14 weekly sessions of approximately 60 minutes each, followed by three scheduled monthly booster sessions and optional symptom-triggered booster sessions during the maintenance phase. ERP may be delivered in person or by HIPAA-compliant telehealth. Clinical assessments are used to measure OCD symptoms and related outcomes over time, and MRI sessions are used to evaluate brain connectivity. Receives: Behavioral: Exposure and Response Prevention Therapy; Other: Clinical Assessments; Diagnostic Test: Research MRI Sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between CY-BOCS-II Total Score and Orbitofrontal Cortex-Ventral Striatum Resting-State Functional Connectivity During Acute ERP
The primary outcome is the within-participant association between obsessive-compulsive disorder symptom severity and resting-state functional connectivity during the acute ERP phase. OCD symptom severity will be measured using the Children's Yale-Brown Obsessive Compulsive Scale, Second Edition total score. OFC-ventral striatum resting-state functional connectivity will be measured using Fisher z-transformed resting-state fMRI connectivity. The association will be estimated using visit-level linear mixed-effects models. CY-BOCS-II total scores range from 0 to 50, with higher scores indicating greater OCD symptom severity.
Measured: Baseline through end-of-acute ERP assessment visit, targeted Week 14
Secondary outcomes (4)
Change From Baseline in CY-BOCS-II Total Score at End of Acute ERP
Clinical symptom change will be measured as the change in Children's Yale-Brown Obsessive Compulsive Scale, Second Edition total score from baseline to the end-of-acute ERP assessment visit. CY-BOCS-II total scores range from 0 to 50, with higher scores indicating greater OCD symptom severity. A decrease in score indicates improvement.
Measured: Baseline to end-of-acute ERP assessment visit, targeted Week 14
Number of Participants With Treatment-Emergent Adverse Events
Safety and tolerability will be assessed by the number and proportion of participants with treatment-emergent adverse events during study participation. Adverse events include unfavorable or unintended signs, symptoms, diseases, or worsening of pre-existing conditions temporally associated with study procedures, whether or not considered related to ERP, MRI/fMRI, symptom-reactivity tasks, or other study procedures.
Measured: From first study procedure through last study visit, up to 62 weeks
Change in CY-BOCS-II Total Score From End of Acute ERP to Last Booster or Maintenance Visit
Maintenance of clinical gains will be assessed as the change in Children's Yale-Brown Obsessive Compulsive Scale, Second Edition total score from the end-of-acute ERP assessment visit to the last booster or maintenance clinical assessment visit. CY-BOCS-II total scores range from 0 to 50, with higher scores indicating greater OCD symptom severity. A decrease in score indicates improvement, while an increase indicates symptom worsening.
Measured: End-of-acute ERP assessment visit, targeted Week 14, to last booster or maintenance clinical assessment visit, up to Week 62
Change in OFC-Ventral Striatum Resting-State Functional Connectivity From End of Acute ERP to Last Booster or Maintenance Imaging Visit
Maintenance of neural change will be assessed as the change in orbitofrontal cortex-ventral striatum resting-state functional connectivity from the end-of-acute ERP imaging visit to the last booster or maintenance imaging visit. Resting-state functional connectivity will be derived from fMRI data and Fisher z-transformed for analysis.
Measured: End-of-acute ERP imaging visit, targeted Week 14, to last booster or maintenance imaging visit, up to Week 62
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2031 (estimated)
Why it stopped: Study withdrawn before participant enrollment because the research team does not plan to initiate the study at this time. The protocol may be reconsidered in the future.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label behavioral intervention study in which all enrolled participants receive exposure and response prevention therapy and undergo repeated clinical and neuroimaging assessments. There is no randomization, comparator group, crossover, or factorial assignment.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Conor Liston, MD, PhD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07570108
- Sponsor's protocol ID
- 25-12029657
- Status last verified
- Aug 2026
- First submitted
- 29 Apr 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because this study enrolls minors and collects sensitive psychiatric, treatment-context, longitudinal clinical, and MRI/fMRI data. Given the small single-site sample and the potentially identifiable nature of repeated neuroimaging and clinical data, public sharing of participant-level data could create an unacceptable risk of re-identification or unintended disclosure. Aggregate results will be reported. Any future external data sharing would require separate IRB approval, consent/assent authorization or waiver as applicable, institutional data-use agreements, and appropriate de-identification or controlled-access safeguards.
Publications
Jaspers-Fayer F, Lin SY, Chan E, Ellwyn R, Lim R, Best J, Belschner L, Lang D, Heran MKM, Woodward TS, Stewart SE. Neural correlates of symptom provocation in pediatric obsessive-compulsive disorder. Neuroimage Clin. 2019;24:102034. doi: 10.1016/j.nicl.2019.102034. Epub 2019 Oct 23.
PubMed 31734533Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.
PubMed 9183141Lynch CJ, Elbau IG, Ng T, Ayaz A, Zhu S, Wolk D, Manfredi N, Johnson M, Chang M, Chou J, Summerville I, Ho C, Lueckel M, Bukhari H, Buchanan D, Victoria LW, Solomonov N, Goldwaser E, Moia S, Caballero-Gaudes C, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Blumberger DM, Kay K, Aloysi A, Gordon EM, Bhati MT, Williams N, Power JD, Zebley B, Grosenick L, Gunning FM, Liston C. Frontostriatal salience network expansion in individuals in depression. Nature. 2024 Sep;633(8030):624-633. doi: 10.1038/s41586-024-07805-2. Epub 2024 Sep 4.
PubMed 39232159Gordon EM, Laumann TO, Gilmore AW, Newbold DJ, Greene DJ, Berg JJ, Ortega M, Hoyt-Drazen C, Gratton C, Sun H, Hampton JM, Coalson RS, Nguyen AL, McDermott KB, Shimony JS, Snyder AZ, Schlaggar BL, Petersen SE, Nelson SM, Dosenbach NUF. Precision Functional Mapping of Individual Human Brains. Neuron. 2017 Aug 16;95(4):791-807.e7. doi: 10.1016/j.neuron.2017.07.011. Epub 2017 Jul 27.
PubMed 28757305Pauls DL, Abramovitch A, Rauch SL, Geller DA. Obsessive-compulsive disorder: an integrative genetic and neurobiological perspective. Nat Rev Neurosci. 2014 Jun;15(6):410-24. doi: 10.1038/nrn3746.
PubMed 24840803McGuire JF, Piacentini J, Lewin AB, Brennan EA, Murphy TK, Storch EA. A META-ANALYSIS OF COGNITIVE BEHAVIOR THERAPY AND MEDICATION FOR CHILD OBSESSIVE-COMPULSIVE DISORDER: MODERATORS OF TREATMENT EFFICACY, RESPONSE, AND REMISSION. Depress Anxiety. 2015 Aug;32(8):580-93. doi: 10.1002/da.22389. Epub 2015 Jun 30.
PubMed 26130211Pediatric OCD Treatment Study (POTS) Team. Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial. JAMA. 2004 Oct 27;292(16):1969-76. doi: 10.1001/jama.292.16.1969.
PubMed 15507582Practice parameter for the assessment and treatment of children and adolescents with obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):98-113. doi: 10.1016/j.jaac.2011.09.019.
PubMed 22176943
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Functional Mapping to Predict and Track ERP Response in Pediatric Obsessive-Compulsive Disorder: A Longitudinal fMRI Study
- ClinicalTrials.gov ID
- NCT07570108
- Acronym / sponsor ID
- 25-12029657
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- Obsessive-compulsive disorder, Pediatric obsessive-compulsive disorder, OCD, Pediatric OCD, Exposure and response prevention, ERP, Cognitive behavioral therapy, Functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn before participant enrollment because the research team does not plan to initiate the study at this time. The protocol may be reconsidered in the future.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether brain scan results can help predict and track changes in obsessive-compulsive disorder, or OCD, symptoms in children and teens ages 10 to 17 who receive Exposure and Response Prevention therapy, also called ERP. ERP is a type of therapy in which participants practice facing OCD-related fears while resisting rituals or compulsions.
The main question this study aims to answer is:
Can each participant's pattern of brain connections, measured with functional MRI brain scans, help predict and track weekly changes in OCD symptoms during and after a 14-week course of ERP, including during planned monthly booster sessions and additional booster sessions offered if symptoms worsen?
All participants will receive ERP. There is no placebo and no comparison group.
Participants will:
- Complete screening, consent or assent, interviews, questionnaires, and MRI safety checks
- Receive 14 weekly ERP sessions
- Complete OCD symptom assessments and functional MRI brain scans before, during, and after ERP
- Receive planned monthly ERP booster sessions after the 14 weekly sessions
- Receive additional brief ERP booster sessions if OCD symptoms worsen during follow-up
- Take part for up to about 62 weeks
Detailed description
This study examines whether individualized brain-connectivity measures obtained with repeated functional magnetic resonance imaging can help predict and track symptom change during exposure and response prevention, an evidence-based cognitive-behavioral therapy for pediatric obsessive-compulsive disorder.
OCD is characterized by obsessions, compulsions, or both, and in youth it can substantially interfere with school, family life, social development, and daily functioning. Although ERP and serotonin reuptake inhibitor medications are standard treatments for pediatric OCD, clinical outcomes vary. Some youth respond robustly, while others have partial improvement, persistent residual symptoms, or symptom recurrence after initial gains. Current clinical practice lacks individualized biological markers that can track treatment response over time or help identify which patients may require more intensive or alternative intervention strategies.
The scientific rationale for this study is that OCD symptoms have been linked to dysfunction in cortico-striato-thalamo-cortical brain circuits, including orbitofrontal cortex and striatal regions. However, these circuits vary across individuals, and group-average neuroimaging findings have not yet yielded clinically useful biomarkers for individual patients. Precision functional mapping uses repeated fMRI scans from the same person to generate individualized estimates of functional brain networks. By pairing ERP with longitudinal clinical assessment and repeated neuroimaging, this study will evaluate whether participant-specific functional connectivity features, particularly resting-state functional connectivity between orbitofrontal cortex and ventral striatum, are associated with changes in OCD symptom severity over time.
The broader anticipated benefit is scientific: the study may help clarify how individualized brain-connectivity patterns change during ERP and how those changes relate to symptom trajectory, treatment response, and maintenance or recurrence of symptoms. Findings may inform future approaches to personalized pediatric OCD care, including earlier identification of youth who may benefit from treatment augmentation or alternative strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label behavioral intervention study in which all enrolled participants receive exposure and response prevention therapy and undergo repeated clinical and neuroimaging assessments. There is no randomization, comparator group, crossover, or factorial assignment.
| Arm | Type | Receives |
|---|---|---|
| Exposure and Response Prevention Therapy | Experimental | Behavioral: Exposure and Response Prevention Therapy, Other: Clinical Assessments, Diagnostic Test: Research MRI SessionsParticipants receive exposure and response prevention (ERP) therapy, an evidence-based form of cognitive behavioral therapy for obsessive-compulsive disorder. Participants also receive repeated clinical assessments and research MRI sessions. ERP consists of 14 weekly sessions of approximately 60 minutes each, followed by three scheduled monthly booster sessions and optional symptom-triggered booster sessions during the maintenance phase. ERP may be delivered in person or by HIPAA-compliant telehealth. Clinical assessments are used to measure OCD symptoms and related outcomes over time, and MRI sessions are used to evaluate brain connectivity. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 10 to 17 years at the time of initial consent. Participants who reach age 18 while enrolled may remain in the study after completing the adult re-consent process; no new participants age 18 years or older will be recruited.
- DSM-5 diagnosis of obsessive-compulsive disorder, established through a clinical interview by a clinician.
- Parent or guardian able to provide informed consent and participant able to provide assent.
- Participant has sufficient English fluency to complete cognitive tasks and assessments. Parent or guardian English fluency is not required; interpreter support is available.
Key exclusion criteria (6 listed)
- History or current evidence of a significant neurological disorder, including but not limited to seizure disorder, stroke, or traumatic brain injury with loss of consciousness.
- Any standard MRI contraindication identified during initial screening or on the MRI safety checklist, including but not limited to ferromagnetic implants, certain medical devices or metal fragments, severe claustrophobia, or pregnancy.
- Pregnancy at screening or pregnancy identified during study participation.
- Active suicidal ideation.
- Any psychiatric condition that, in the investigator's judgment, would interfere with study participation or data interpretation, including but not limited to psychotic disorders, bipolar disorders, severe neurodevelopmental disorders, intellectual disability, severe eating disorders, or recent significant substance use disorders within the past 6 months. Stable psychiatric comorbidities, including anxiety disorders, depressive disorders, ADHD, or tic disorders, are permitted if OCD remains the primary diagnosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure and Response Prevention TherapyAlso: Exposure and Response Prevention, ERPExposure and response prevention (ERP) is an evidence-based form of cognitive behavioral therapy for obsessive-compulsive disorder. ERP involves graded exposure to obsession-triggering cues while supporting participants in refraining from compulsive responses. In this study, participants receive 14 planned weekly ERP sessions of approximately 60 minutes each, followed by three scheduled monthly booster sessions and optional symptom-triggered booster sessions during the maintenance phase. ERP may be delivered in person or by HIPAA-compliant telehealth. | Behavioural | Exposure and Response Prevention Therapy |
| Clinical AssessmentsParticipants complete repeated clinical assessments according to the study schedule to evaluate obsessive-compulsive disorder symptom severity, symptom change, functioning, safety, and related clinical outcomes over time. Assessments may include clinician-administered ratings, participant-report measures, and other study outcome measures. These assessments are conducted for research and clinical monitoring purposes and are not intended as a therapeutic intervention. | Other | Exposure and Response Prevention Therapy |
| Research MRI SessionsParticipants complete research magnetic resonance imaging sessions at scheduled study time points to acquire structural and functional MRI data, including functional MRI measures used to evaluate brain connectivity over time. Imaging sessions are used to examine changes in brain circuitry in relation to obsessive-compulsive disorder symptoms and treatment course. These sessions are conducted for research measurement purposes and are not intended to provide clinical diagnosis or treatment. | Diagnostic test | Exposure and Response Prevention Therapy |
Primary outcome
Association Between CY-BOCS-II Total Score and Orbitofrontal Cortex-Ventral Striatum Resting-State Functional Connectivity During Acute ERP
Time frame: Baseline through end-of-acute ERP assessment visit, targeted Week 14
The primary outcome is the within-participant association between obsessive-compulsive disorder symptom severity and resting-state functional connectivity during the acute ERP phase. OCD symptom severity will be measured using the Children's Yale-Brown Obsessive Compulsive Scale, Second Edition total score. OFC-ventral striatum resting-state functional connectivity will be measured using Fisher z-transformed resting-state fMRI connectivity. The association will be estimated using visit-level linear mixed-effects models. CY-BOCS-II total scores range from 0 to 50, with higher scores indicating greater OCD symptom severity.
4 secondary outcomes
Change From Baseline in CY-BOCS-II Total Score at End of Acute ERP
Time frame: Baseline to end-of-acute ERP assessment visit, targeted Week 14
Number of Participants With Treatment-Emergent Adverse Events
Time frame: From first study procedure through last study visit, up to 62 weeks
Change in CY-BOCS-II Total Score From End of Acute ERP to Last Booster or Maintenance Visit
Time frame: End-of-acute ERP assessment visit, targeted Week 14, to last booster or maintenance clinical assessment visit, up to Week 62
Change in OFC-Ventral Striatum Resting-State Functional Connectivity From End of Acute ERP to Last Booster or Maintenance Imaging Visit
Time frame: End-of-acute ERP imaging visit, targeted Week 14, to last booster or maintenance imaging visit, up to Week 62
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Background: PubMed 31734533Jaspers-Fayer F, Lin SY, Chan E, Ellwyn R, Lim R, Best J, Belschner L, Lang D, Heran MKM, Woodward TS, Stewart SE. Neural correlates of symptom provocation in pediatric obsessive-compulsive disorder. Neuroimage Clin. 2019;24:102034. doi: 10.1016/j.nicl.2019.102034. Epub 2019 Oct 23.
- Background: PubMed 9183141Scahill L, Riddle MA, McSwiggin-Hardin M, Ort SI, King RA, Goodman WK, Cicchetti D, Leckman JF. Children's Yale-Brown Obsessive Compulsive Scale: reliability and validity. J Am Acad Child Adolesc Psychiatry. 1997 Jun;36(6):844-52. doi: 10.1097/00004583-199706000-00023.
- Background: PubMed 39232159Lynch CJ, Elbau IG, Ng T, Ayaz A, Zhu S, Wolk D, Manfredi N, Johnson M, Chang M, Chou J, Summerville I, Ho C, Lueckel M, Bukhari H, Buchanan D, Victoria LW, Solomonov N, Goldwaser E, Moia S, Caballero-Gaudes C, Downar J, Vila-Rodriguez F, Daskalakis ZJ, Blumberger DM, Kay K, Aloysi A, Gordon EM, Bhati MT, Williams N, Power JD, Zebley B, Grosenick L, Gunning FM, Liston C. Frontostriatal salience network expansion in individuals in depression. Nature. 2024 Sep;633(8030):624-633. doi: 10.1038/s41586-024-07805-2. Epub 2024 Sep 4.
- Background: PubMed 28757305Gordon EM, Laumann TO, Gilmore AW, Newbold DJ, Greene DJ, Berg JJ, Ortega M, Hoyt-Drazen C, Gratton C, Sun H, Hampton JM, Coalson RS, Nguyen AL, McDermott KB, Shimony JS, Snyder AZ, Schlaggar BL, Petersen SE, Nelson SM, Dosenbach NUF. Precision Functional Mapping of Individual Human Brains. Neuron. 2017 Aug 16;95(4):791-807.e7. doi: 10.1016/j.neuron.2017.07.011. Epub 2017 Jul 27.
- Background: PubMed 24840803Pauls DL, Abramovitch A, Rauch SL, Geller DA. Obsessive-compulsive disorder: an integrative genetic and neurobiological perspective. Nat Rev Neurosci. 2014 Jun;15(6):410-24. doi: 10.1038/nrn3746.
- Background: PubMed 26130211McGuire JF, Piacentini J, Lewin AB, Brennan EA, Murphy TK, Storch EA. A META-ANALYSIS OF COGNITIVE BEHAVIOR THERAPY AND MEDICATION FOR CHILD OBSESSIVE-COMPULSIVE DISORDER: MODERATORS OF TREATMENT EFFICACY, RESPONSE, AND REMISSION. Depress Anxiety. 2015 Aug;32(8):580-93. doi: 10.1002/da.22389. Epub 2015 Jun 30.
- Background: PubMed 15507582Pediatric OCD Treatment Study (POTS) Team. Cognitive-behavior therapy, sertraline, and their combination for children and adolescents with obsessive-compulsive disorder: the Pediatric OCD Treatment Study (POTS) randomized controlled trial. JAMA. 2004 Oct 27;292(16):1969-76. doi: 10.1001/jama.292.16.1969.
- Background: PubMed 22176943Practice parameter for the assessment and treatment of children and adolescents with obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2012 Jan;51(1):98-113. doi: 10.1016/j.jaac.2011.09.019.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because this study enrolls minors and collects sensitive psychiatric, treatment-context, longitudinal clinical, and MRI/fMRI data. Given the small single-site sample and the potentially identifiable nature of repeated neuroimaging and clinical data, public sharing of participant-level data could create an unacceptable risk of re-identification or unintended disclosure. Aggregate results will be reported. Any future external data sharing would require separate IRB approval, consent/assent authorization or waiver as applicable, institutional data-use agreements, and appropriate de-identification or controlled-access safeguards.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conor Liston, MD, PhD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and Response Prevention Therapy, Clinical Assessments and Research MRI Sessions in people with Obsessive-Compulsive Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between CY-BOCS-II Total Score and Orbitofrontal Cortex-Ventral Striatum Resting-State Functional Connectivity During Acute ERP (time frame: Baseline through end-of-acute ERP assessment visit, targeted Week 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07570108, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.