Rituximab for Obsessive-compulsive Disorder. (RITS-PO-2019)

NCT03983031 | Completed Phase 1

• 1 other identifier: EudraCT Number: 2018-004619-28
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant obsessive-compulsive disorder in an open trial.

Conditions

Obsessive-Compulsive Disorder; Treatment Resistant Disorders

Keywords

Immunopsychiatry; pediatric acute-onset neuropsychiatric syndrome

Outcome Measures

Primary Outcomes (1)

• Yale-Brown obsessive- compulsive scale (Y-BOCS)

  Y-BOCS maps symptoms and measures severity of obsessive-compulsive symptoms by a clinician. Y-BOCS has a range between 0 and 40 points, higher scores denotes worse symptoms. Outcome is measured as change in Y-BOCS score from baseline. At least 35% reduction in the score since baseline is defined as a response.

  week 20

Secondary Outcomes (6)

• Personal and Social Performance Scale (PSP)

  week 20

• Clinical Global Impression-severity (CGI-S) scale

  week 20

• Clinical Global Impression-Improvement (CGI-I) in relation to inflammatory markers

  week 20

• Clinical Global Impression-Improvement (CGI-I). Proportion of responders.

  week 20

• Clinical Global Impression-Improvement (CGI-I).

  week 20

Other Outcomes (9)

• Yale-Brown obsessive- compulsive scale (Y-BOCS)

  week 40

• Personal and Social Performance Scale (PSP)

  week 40

• Clinical Global Impression-severity (CGI-S) scale

  week 40

Interventions

Rituximab DRUG

Infusion

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patient ages 18 to 40 years.
• a duration of illness exceeding 2 years.
• correspond to "Markedly ill", "Severely ill" or "Among the most extremely ill patients" on the Clinical Global Impression - Severity scale (CGI-S).
• Global Assessment of Functioning (GAF) below 50.
• obsessive-compulsive disorder according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
• treatment resistance, i.e. failing to remit despite adequate treatments.
• if female and with any risk for pregnancy, willing to use contraceptives.
• if psychotropic treatment is prescribed the plasma concentrations of the drug must be tested and shown to be within therapeutic interval.
• subjects should be judged by the investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent.
• immunoglobulin levels within the normal range.

You may not qualify if:

• on-going immunomodulatory treatment.
• pregnancy or breast-feeding.
• weight below 40 kg.
• clinically relevant on-going infection.
• chronic infections .
• positive screening test for hepatitis B, C, HIV or tuberculosis
• any change of psychotropic medication within the previous 4 weeks
• "much" or "very much" improved already at baseline according to CGI-I.
• severe heart failure (NYHA grade IV) or other severe heart disease or history of cardiac arrhythmia or myocardial infarction.
• unable to make an informed decision to consent to the trial.
• in compulsory treatment.
• treatment with clozapine within the last 2 months.
• previous treatments with immunosuppressive agents.

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro University, Sweden: collaborator

Study Sites (2)

Region Örebro län

Örebro, 70116, Sweden

Location

Region Örebro Län

Örebro, 70356, Sweden

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Pediatric acute-onset neuropsychiatric syndrome

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Susanne Bejerot, MD

  Region Örebro län

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: June 12, 2019
• Study Start: August 8, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)