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| Name | Class |
|---|---|
| Örebro University, Sweden | OTHER |
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This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant obsessive-compulsive disorder in an open trial.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab | Drug | Infusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Personal and Social Performance Scale (PSP) | Personal and Social Performance Scale (PSP) gives a score for disability. The PSP is a 100-point single-item rating scale (range 1-100), subdivided into 10 equal intervals. Lower scores denote lower functioning. The ratings are based mainly on the assessment of patient's functioning in four main areas: 1) socially useful activities; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviours. Change in score between enrolment and week 20 will be measured. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 40 |
Inclusion Criteria (Swedish citizens):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Bejerot, MD | Region Örebro län | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Örebro län | Örebro | 70116 | Sweden | |||
| Region Örebro Län |
Details that can identify the patients will not be shared.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2024 | |
| Reset | Jan 10, 2025 | |
| Release | Jan 26, 2025 | |
| Reset | Feb 18, 2025 | |
| Release | Mar 11, 2025 | |
| Reset | Mar 20, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2024 | Jan 10, 2025 | |||
| Jan 26, 2025 |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| C000631768 | Pediatric acute-onset neuropsychiatric syndrome |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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.
| week 20 |
| Clinical Global Impression-severity (CGI-S) scale | CGI-S is a clinician rated measure of overall clinical severity that is rated on a scale between 1 and 7. A person with no clinical complaints or problems will get a score of 1. The score 7 indicates the highest level of severity is phrased as "Among the most extremely ill patients". | week 20 |
| Clinical Global Impression-Improvement (CGI-I) in relation to inflammatory markers | Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Change in inflammatory markers in blood (gene expression and proteins) towards normality, in relation to clinical response (assessed by the clinician) will be measured. | week 20 |
| Clinical Global Impression-Improvement (CGI-I). Proportion of responders. | Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Three different informants base their CGI-I evaluations on independent assessments: a) The treating clinician, b) The patient's self-assessment and c) A next of kin. If the mean value of these three is below 2.5 then the patient will be regarded as a responder (representing much or very much improved since baseline). | week 20 |
| Clinical Global Impression-Improvement (CGI-I). | Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Three different informants base their CGI-I evaluations on independent assessments: a) The treating clinician, b) The patient's self-assessment and c) A next of kin. Range 3-21. A lower score depicts larger improvement. | week 20 |
| Adverse event: Any Adverse Reactions (AAR). Safety and tolerability of Rituximab | Any Adverse reactions (AAR) is a rating scale developed for this study and is not a validated questionnaire. It consists of a list of 26 symptoms. AAR maps adverse events related to rituximab treatment. These items are assessed for severity on a Likert scale (4 levels: none; mild; moderate; severe) and frequency (3 levels: occasionally; daily; several times daily). AAR is assessed by the clinician. An adverse event scale was required as an outcome measure by the Swedish Medical Products Agency. | week 20 |
| Personal and Social Performance Scale (PSP) | Personal and Social Performance Scale (PSP) gives a score for disability. The PSP is a 100-point single-item rating scale (range 1-100), subdivided into 10 equal intervals. Lower scores denote lower functioning. The ratings are based mainly on the assessment of patient's functioning in four main areas: 1) socially useful activities; 2) personal and social relationships; 3) self-care; and 4) disturbing and aggressive behaviours. Change in score between enrolment and week 40 will be measured. | week 40 |
| Clinical Global Impression-severity (CGI-S) scale | CGI-S is a clinician rated measure of overall clinical severity that is rated on a scale between 1 and 7. A person with no clinical complaints or problems will get a score of 1. The score 7 indicates the highest level of severity is phrased as "Among the most extremely ill patients". | week 40 |
| Clinical Global Impression-Improvement (CGI-I) in relation to inflammatory markers | Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Change in inflammatory markers in blood (gene expression and proteins) towards normality, in relation to clinical response (assessed by the clinician) will be measured. | week 40 |
| Changes in cognitive functioning | Improvement in cognitive tests using a subset of tests included in Wechsler Adult Intelligence Scale (WAIS) (i.e. Block design, digit span, letter number sequencing and digit symbol coding, visuospatial test). | week 20 |
| CGI-I in relation to treatment and evaluated by the treating clinician, the patient's self-assessment and a next of kin | Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Three different informants base their CGI-I evaluations on independent assessments: a) The treating clinician, b) The patient's self-assessment and c) A next of kin. Range 3-21. A lower score depicts larger improvement. | week 40 |
| B cell subpopulations in relation to clinical response | B-cell depletion at week 5, and B-cell subpopulations at week 20 in relation to clinical response (CGI-I) (assessed by the clinician) and baseline levels of B-cells. | week 20 |
| Life quality measured with Brunnsviken Brief Quality of Life Scale (BBQ) | BBQ is a 12-item self-rated measurement of life satisfaction, it is a likert scale, range 0-48. Higher scores denote higher life satisfaction. | week 40 |
| Clinical Global Impression-Improvement (CGI-I). Proportion of responders. | Clinical Global Impression-Improvement scale (CGI-I) measures change of symptoms on a 7 point Likert scale. A CGI-I score of 1 or 2 corresponds to be much or very much improved. Three different informants base their CGI-I evaluations on independent assessments: a) The treating clinician, b) The patient's self-assessment and c) A next of kin. If the mean value of these three is below 2.5 then the patient will be regarded as a responder (representing much or very much improved since baseline). | week 40 |
| Örebro |
| 70356 |
| Sweden |
| Feb 18, 2025 |
| Mar 11, 2025 | Mar 20, 2025 |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |