Rituximab - Immunotherapy for Obsessive-compulsive Disorder: An Open Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- Yale-Brown obsessive- compulsive scale (Y-BOCS)
研究概览
简要总结
This study evaluates the addition of rituximab to 12 patients diagnosed with treatment resistant obsessive-compulsive disorder in an open trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(Swedish citizens):
- •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
- •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.
排除标准
- •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.
- •malignancy currently or within 2 years prior to inclusion.
结局指标
主要结局
Yale-Brown obsessive- compulsive scale (Y-BOCS)
时间窗: week 20
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.
次要结局
- 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)
- Personal and Social Performance Scale (PSP)(week 20)
- Adverse event: Any Adverse Reactions (AAR). Safety and tolerability of Rituximab(week 20)
研究者
Susanne Bejerot
Principal investigator
Region Örebro County