Rituximab for Obsessive-compulsive Disorder. (RITS-PO-2019)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Obsessive Compulsive Disorder
- Treatment Resistant Disorders
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: Single (Outcomes Assessor)Masking Description: Each patient will be video recorded at base line, week 12, 20 and 40 in order to enable blinded assessment by an independent rater, and for the patient's own evaluation.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Both males and females
Description
Immunological factors may be determinants for some psychiatric disorders, thus immunomodulation may be helpful. Rituximab (antibodies against CD20, cluster of differentiation), a standard treatment for multiple sclerosis, is an anti-inflammatory drug, hitherto not tested for psychiatric disorders. T...
Immunological factors may be determinants for some psychiatric disorders, thus immunomodulation may be helpful. Rituximab (antibodies against CD20, cluster of differentiation), a standard treatment for multiple sclerosis, is an anti-inflammatory drug, hitherto not tested for psychiatric disorders. The aim of this study is to investigate whether the psychiatric symptoms of treatment-resistant adult psychiatric patients, diagnosed with obsessive-compulsive disorder (OCD), are significantly improved after treatment with rituximab. The investigator's purpose is to implement recent insights from "Immunopsychiatry" to find efficacious, but still tolerable treatment for these patients. This is a single-site, 20-week, open pilot, add-on treatment as usual, trial, where the patients will be followed for 1 year. Rituximab will be administered with one single dose of 1000 mg. Investigators will analyse inflammatory and metabolic biomarkers in relation to the primary outcome, treatment response (defined as clinically relevant reduction in the validated measure Y-BOCS). Other outcomes are "much" or "very much improved" on Clinical Global Impression - Improvement scale (CGI-I) and change in Personal and Social Performance Scale measuring overall disability.
Tracking Information
- NCT #
- NCT03983031
- Collaborators
- Örebro University, Sweden
- Investigators
- Principal Investigator: Susanne Bejerot, MD Region Örebro län
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