A randomized, double-blinded, placebo-controlled study of Rituximab in patients with Psychosis and/or Obsessive Compulsive Disorder, with an indication of immune system involvement.

Conditions

Psychosis and or Obsessive Compulsive Disorder, with an indication of immune system involvement

Brief summary

The clinical efficacy of Rituximab treatment will be evaluated by calculating the average difference between BPRS scores at baseline and main-evaluation (8-month) and comparing it between the treatment-first and the placebo-first group.

Detailed description

1. The amelioration in psychiatric symptomatology will be assessed by following the psychiatric rating scales: o CGI o WHODAS, o EQ-VAS, o Y-BOCS o BFCS, 2. Improvement in executive functions, will be assessed by following neuropsychiatric tests: o Neuropsychological tests o Mismatch negativity, 3. The amelioration of neurological symptoms will be assessed by performing complete, video-recorded neurological exams. This procedure is described in section 11., 4. The longevity of psychiatric, neurological and executive improvements will be examined by the psychiatric ratings scales named in 1. and blood samples every 4 months up to 16 months, and in addition to that a thorough neurological exam, the executive tests named in 2. and CSF samples every 8 months up to 16 months., 5. The safety of Rituximab treatment will be assessed by adverse events monitoring and questionnaires described in detail in section 12.

Related papers

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Interventions

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
The clinical efficacy of Rituximab treatment will be evaluated by calculating the average difference between BPRS scores at baseline and main-evaluation (8-month) and comparing it between the treatment-first and the placebo-first group.	—

Secondary

Measure	Time frame
1. The amelioration in psychiatric symptomatology will be assessed by following the psychiatric rating scales: o CGI o WHODAS, o EQ-VAS, o Y-BOCS o BFCS, 2. Improvement in executive functions, will be assessed by following neuropsychiatric tests: o Neuropsychological tests o Mismatch negativity, 3. The amelioration of neurological symptoms will be assessed by performing complete, video-recorded neurological exams. This procedure is described in section 11., 4. The longevity of psychiatric, neurological and executive improvements will be examined by the psychiatric ratings scales named in 1. and blood samples every 4 months up to 16 months, and in addition to that a thorough neurological exam, the executive tests named in 2. and CSF samples every 8 months up to 16 months., 5. The safety of Rituximab treatment will be assessed by adverse events monitoring and questionnaires described in detail in section 12.	—

Measure

Time frame

1. The amelioration in psychiatric symptomatology will be assessed by following the psychiatric rating scales: o CGI o WHODAS, o EQ-VAS, o Y-BOCS o BFCS, 2. Improvement in executive functions, will be assessed by following neuropsychiatric tests: o Neuropsychological tests o Mismatch negativity, 3. The amelioration of neurological symptoms will be assessed by performing complete, video-recorded neurological exams. This procedure is described in section 11., 4. The longevity of psychiatric, neurological and executive improvements will be examined by the psychiatric ratings scales named in 1. and blood samples every 4 months up to 16 months, and in addition to that a thorough neurological exam, the executive tests named in 2. and CSF samples every 8 months up to 16 months., 5. The safety of Rituximab treatment will be assessed by adverse events monitoring and questionnaires described in detail in section 12.

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Countries

Sweden

Outcome results

None listed