Predicting Treatment Response in Patients With OCD

• Status: Recruiting
• Trial end date: 2021-12-21
• Target enrollment: 0
• Participant gender: All

Summary

This study consists of a naturalistic follow-up of subjects with Obsessive-Compulsive Disorder (OCD) that have participated in a global study investigating brain signatures of OCD funded by the National Institutes of Mental Health (RO1MH113250), with the following participant sites: the US (Columbia University, PI: Helen Blair Simpson), Brazil (University of Sao Paulo, PIs: Euripedes Miguel and Roseli G Shavitt), India (National Institutes of Mental Health, PI: Janardhan Reddy), The Netherlands (VU Amsterdam Medical Center, PI: Odile van den Heuvel), and South Africa (University of Cape Town, PI: Dan Stein; Stellenbosch University, PI: Christine Lochner). In this cross-sectional study, two-hundred and fifty unmedicated subjects with OCD (50 per site) will be assessed for clinical, neurocognitive and neuroimaging data. After completion of this study, participants willing to receive evidence-based treatments for OCD will be treated with the available resources in each site and will be assessed for treatment response status periodically, with a final assessment after 1 year of naturalistic follow-up. At this point, we will investigate baseline clinical, neurocognitive and neuroimaging variables associated with the treatment response status.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sao Paulo
• Collaborators: Columbia University; National Institute of Mental Health and Neuro Sciences, India; University of Stellenbosch; VU University Medical Center
• Treatments: Serotonin; Serotonin Uptake Inhibitors

Criteria

Inclusion Criteria:

• Principal DSM-5 diagnosis of OCD

• Y-BOCS ≥ 16

• No psychotropic meds for the last 6 weeks, with the exception of PRN sleeping meds (e.g., zolpidem or trazodone up to 50 mg) and benzos, as long as not within the past week or during study participation

• No CBT/EXRP focused on OCD within the past 6 weeks

• Capable of providing informed consent

Exclusion Criteria:

• Lifetime diagnosis of psychotic disorder, bipolar disorder, anorexia nervosa, autism spectrum disorder with IQ < 80, Tourette Disorder

• Current chronic tic disorder (current = in the past 12 months)

• Current substance-related and addictive disorders, including nicotine (current = in the past 12 months)

• Current binge-eating disorder or bulimia (current = in the past 12 months)

• Acute risk of suicide

• Female who is pregnant

• Major medical or neurological problems (including head injury with loss of consciousness) Presence of metallic devices or dental braces

• IQ < 80

• Cigarette use: more than 5 per day

• Alcohol use: more than 2 drinks per day for women and more than 3 drinks per day for men, Marijuana use: more than once per week