NCT05048251 Individually Targeted Neuromodulation for Contamination-based OCD
| NCT ID | NCT05048251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mclean Hospital |
| Condition | Obsessive-Compulsive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2024-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2022-07-01 with a primary completion date of 2024-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with obsessive-compulsive disorder (OCD) experience a wide array of different types of obsessions and compulsions. However, current treatments for OCD employ a "one size fits all" approach and are used for all patients regardless of symptom type. In this project, the investigators propose to investigate whether a novel method of transcranial magnetic stimulation specifically reduces contamination/washing symptoms - one of the most common types of OCD.
Eligibility Criteria
Inclusion Criteria: 1. male or female age 18-55 years old 2. DSM-5 diagnosis of OCD as primary presenting disorder 3. CONTAM as the predominant symptom dimension (i.e., Dimension 4 (CONTAM symptoms) is the highest score on the Dimensional Yale-Brown Obsessive Compulsive Scale (D-YBOCS); participants with more than one Dimension as highest score will still be eligible as long as Dimension 4 is one of these) 4. score of ≥ 8 on Dimension 4 of the D-YBOCS 5. taking no psychiatric medications or on a stable dose of an SSRI, clomipramine, SNRI, or second generation antipsychotic for at least 4 weeks prior to enrollment. Use of PRN benzodiazepines will be permitted as long as the dose/usage has not changed significantly leading up to enrollment. No medication changes will be permitted during the study 6. have not initiated a new course of exposure and response prevention (ERP) therapy within 4 weeks of enrollment (ongoing ERP will be permitted if initiated more than 8 weeks before enrollment). Exclusion Criteria: 1. positive urine drug screen (other than prescribed benzodiazepines) 2. use of psychiatric medications other than permitted above 3. substance use disorder in the last 3 months (with the exception of nicotine) 4. history of schizophrenia, bipolar disorder, autism, Tourette's syndrome (current and past history of depressive, anxiety, and eating disorders permitted as long as OCD is considered the primary disorder) 5. active suicidal ideation over the week prior to screening (as indicated by answering yes to questions 1 or 2 on the C-SSRS) 6. history of traumatic brain injury, seizure disorder, neurodegenerative disease, or other organic brain disease 7. pregnancy or lactating 8. contraindication to MRI scanning or TMS
Contact & Investigator
Brian P Brennan, MD
PRINCIPAL INVESTIGATOR
Mclean Hospital
Frequently Asked Questions
Who can join the NCT05048251 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Obsessive-Compulsive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05048251 currently recruiting?
Yes, NCT05048251 is actively recruiting participants. Contact the research team at rsokoll@mgh.harvard.edu for enrollment information.
Where is the NCT05048251 trial being conducted?
This trial is being conducted at Belmont, United States.
Who is sponsoring the NCT05048251 clinical trial?
NCT05048251 is sponsored by Mclean Hospital. The principal investigator is Brian P Brennan, MD at Mclean Hospital. The trial plans to enroll 50 participants.