Brain changes linked to treatment responses in OCD

Brain Network Changes Accompanying and Predicting Responses to Pharmacotherapy in OCD

This study is testing how treatment with fluoxetine affects brain activity in people with obsessive-compulsive disorder (OCD) to see if it helps improve their symptoms.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT04131829 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with OCD who are treatment-seeking and not currently on psychoactive medications.

Not a fit: Patients who are currently taking psychoactive medications or those who do not meet the diagnostic criteria for OCD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for patients with OCD by identifying neural predictors of response to pharmacotherapy.

How similar studies have performed: Other studies have shown promise in using neuroimaging to understand treatment responses in psychiatric disorders, suggesting this approach may yield valuable insights.

Eligibility criteria

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 this trial is running

New Haven, Connecticut

• 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

Conditions Obsessive-Compulsive Disorder