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Rituximab for Psychosis and OCD with Immune Involvement
NCT04323566Phase 2
Key facts
- Status
- Enrolling by invitation
- Start
- May 2022
- Primary completion
- Apr 2028
- Countries
- 1
- Sponsor
- Akademiska sjukhuset
- Modality
- Monoclonal Antibodies
- Drugs
- rituximab
- Conditions
- psychosisobsessive compulsive disorder (OCD)
01
Overview
Phase 2, randomised, double-blind trial of rituximab in psychosis and obsessive compulsive disorder (OCD) (2 arms), sponsored by Akademiska sjukhuset. Primary endpoint: Brief Psychiatric Rating Scale at 8 months. Started May 2022; status: enrolling by invitation.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Treatment-first arm
Rituximab (0-4mo) -> Placebo (8-12mo)
Placebo-first arm
Placebo (0-4mo) -> Rituximab (8-12mo)
03
Who it enrols
Adult patients (18-55) with psychosis or OCD/OCB and signs of immune system involvement who have failed at least 2 standard psychiatric medications. Excludes patients with HIV, Hepatitis, TB, pregnancy, substance abuse, or prior Rituximab treatment.
04
Endpoints
Primary
Brief Psychiatric Rating Scale
Secondary
World Health Organization Disability Assessment Schedule
Clinical Global Impression
EuroQol Visual Analogue Scale
Yale Brown Obsessive Compulsion Scale
Bush-Francis Catatonia Rating Scale
Mismatch Negativity
Neurological Examination
Plasma/Serum and CSF Immune Markers
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