Brain changes linked to treatment responses in OCD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research involves a randomized, double-blind study using functional magnetic resonance imaging (fMRI) to explore brain network changes in individuals with obsessive-compulsive disorder (OCD) undergoing treatment with fluoxetine, a selective serotonin reuptake inhibitor. Participants will be divided into two groups: one receiving immediate treatment and another receiving a placebo, with both groups undergoing fMRI scans at baseline and throughout the treatment period. The study aims to identify neural dysconnectivity associated with OCD symptoms, characterize neural markers of treatment response, and map predictors of clinical outcomes. The findings could enhance understanding of how brain activity correlates with treatment efficacy in OCD.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Inclusion criteria for all groups will include: (i) Adults, Men and women will be included, in a 1:1 ratio; and efforts will be made to recruit racial and ethnic subgroups. Groups will be further matched on age, handedness; and later, in analysis, on educational status and smoking history.

(ii) signed informed consent, approved by the Yale Human Investigations Committee; and (iii) ability and willingness to participate in all study procedures, including clinical assessments and fMRI scans.

* Additional inclusion criteria:
* OCD Participants:

  (i) a DSM diagnosis of OCD, established as detailed above; (ii) a baseline Y-BOCS of ≥16; (iii) no current psychoactive medication, with the exception of the occasional use of a PRN medication for sleep; (iv) treatment seeking, and clinically appropriate for fluoxetine pharmacotherapy; (v) for women of childbearing potential, not pregnant or intending to become pregnant, and willing to use reliable birth control over the course of the study, either prescribed contraceptive (oral contraceptive, injectable, or implant) or one barrier method (e.g. diaphragm with spermicide, intrauterine device, cervical cap). Women of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy tests at the study baseline and on each scan day appointment prior to the MRI scan.
* Healthy Control Participants:

  (i) no current DSM diagnosis (by clinician interview confirmed by SCID or MINI); (ii) no documented or clinically suspected family history in a first- or second- degree relative of OCD, Tourette syndrome, hoarding disorder, body dysmorphic disorder, or a compulsive grooming disorder.

Exclusion Criteria:

* Exclusion criteria for all groups will include:

  (i) any unstable medical, psychiatric, or neurological condition (including active or otherwise problematic suicidality) that may necessitate urgent treatment; (ii) any substance use disorder within the past 6 months; (iii) use of psychotropic medications within the past 8 weeks, with the exception of occasional use of a sleep aid or analgesic; (iv) use of an as-needed sleep aid or prescription analgesic within 3 days of the scan; (v) any history of a primary psychotic disorder or of mania; (vi) any evidence of substance use on urine toxicology testing; (vii) any major neurological disease or history of major head trauma, including concussion with extended loss of consciousness; (viii) pregnancy; (ix) any metal in the body or other contraindication to MRI scanning; (x) severe claustrophobia, back pain, or other condition that may make an extended MR scan difficult or lead to excessive movement during the scan.
* Additional exclusion criteria:
* OCD Participants:

  (i) past allergy or adverse reaction to fluoxetine or another SSRI, or other clinical contraindication to fluoxetine pharmacotherapy; (ii) documented nonresponse to a past trial of fluoxetine of appropriate dose (≥40 mg/dy) and duration (≥12 weeks).

(iii) Patients taking Coumadin or Monoamine oxidase inhibitors (MAOIs) will be excluded from the study.

Where it's running

• Yale OCD Research Clinic - CMHC/CNRU, 34 Park ST
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Christopher Pittenger, MD, PhD — Professor of Psychiatry; Director, Yale OCD Research Clinic
• Study coordinator: Yale OCD Research Clinic
• Email: ocd.research@yale.edu
• Phone: 1-855-623-9253

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-intensity focused ultrasound targeting the subthalamic nucleus for OCD

  A short test is being done to see if a wearable, non-invasive ultrasound device can safely and tolerably help adults with OCD by targeting a brain region called the subthalamic nucleus.

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• Mindfulness-Based Cognitive Therapy for OCD Delivered Online

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• Targeted brain stimulation for OCD: test of tTIS on nucleus accumbens

  This study tests whether targeted temporal interference stimulation of the nucleus accumbens can help reduce obsessive-compulsive symptoms in adults with OCD, compared with sham stimulation.

  Recruiting Beijing HuiLongGuan Hospital · Hefei, Anhui · NCT07805200

• Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety

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  Recruiting Ohio State University · Columbus, Ohio · NCT07774481

• AttunE LIFU for OCD: a non-invasive brain stimulation study

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• Combined ERP and Habit Reversal Therapy for Tourettic OCD

  This study tests whether a merged Exposure and Response Prevention and Habit Reversal Therapy helps adults with Tourettic OCD more than either therapy alone or basic psychoeducation.

  Recruiting at 2 sites University College London Hospitals · London, London and 1 other locations · NCT07725926

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.