Authorised Therapeutic exploratory (Phase II) Psychosis and or Obsessive Compulsive Disorder, with an indication of immune system involvement

RA-P-OCD-01

EU CTIS ID: 2024-518391-31-00

What this study is testing

Is to evaluate whether Rituximab as compared to placebo is a clinically effective treatment for a subgroup of patients suffering from psychosis and/or obsessive-compulsive disorder (OCD) or -behavior (OCB) where there is an indication of immune system involvement.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patients to be included in this study meet the criteria for at least one of the following ICD 10 CM diagnoses: o Obsessive-compulsive disorder ICD F42 or o Obsessive-compulsive behavior ICD R46.81 o Schizophrenia, delusional, and other non-mood psychotic disorders, namely  F20 Schizophrenia  F22 Delusional disorders  F23 Brief psychotic disorder  F25 Schizoaffective disorders  F28 Other psychotic disorder not due to a substance or known physiological condition  F29 Unspecified psychosis not due to a substance or known physiological condition
  • The clinical picture indicates active inflammatory activity (see specific criteria below), potential for rehabilitation and time from disease and/or episode debut is no longer than 10 years.
  • Acute (<12 weeks) or atypical debut, or episodes of any of the following: a. Symptoms of encephalopathy:  psychotic symptoms, including hallucinations, delusions, paranoia, disorganized speech, disorganized behavior  agitation, confusion  sudden change in personality as perceived by the social environment  drowsiness  loss of functions in daily life  cognitive problems (memory, speech, learning)  emotional dysregulation b. Focal neurological symptoms, e.g.  ataxia, dystonia, myoclonus, sensory losses, paresthesia c. Psychomotor anomaly,  e.g. retardation, catatonic symptoms, parkinsonism d. Loss of drive (sleep, appetite, libido, motivation) e. Obsessions, compulsions (OCD/OCB), f. Hypo- or hypervigilance (for e.g sounds, emotions, other peoples´ or own behavior) g. Sleeping disorders, AND
  • AND At least one of the following criteria: a. Prodromal phase with infection or symptoms of infection (fever, malaise, etc) b. Clinical improvement of psychiatric symptoms after treatment with anti-inflammatory medications other than antibody therapy (such as steroids, NSAIDs IVIG, plasmaphereses), or antibiotics c. Radiological evidence of neuroinflammation (MR) d. EEG pathology or witnessed epileptic seizure e. Biochemical evidence of inflammation, autoimmunity or blood-brain barrier dysfunction in blood or CSF samples, such as one of the following:  presence of oligoclonal bands  elevated CSF cell count  elevated albumin quotient, or elevated albumin in CSF  elevated IgG ratio  elevated levels of neurofilament f. Patient history of autoimmune disorder not associated with neuroinflammation, such as type 1 diabetes, rheumatoid arthritis, Sjögren´s syndrome, inflammatory bowel disease (IBD, comprising Crohn´s disease and ulcerative colitis), celiac disease, Grave´s disease, Hashimoto`s thyroiditis g. Biochemical indication of autoimmunity such as elevated serum anti-TPO, ANA, ANCA, RF or GAD antibodies, PANDAS panel with relationship to symptom development.
  • Age: 18-55
  • Severity: Clinical Global impression (CGI): Minimum score of “4 = Moderately ill”

You likely can't join if

  • Concomitant malignancies or previous malignancies within the last five years
  • Pregnancy at any time during the study
  • Known chronical significant bacterial/viral/fungal infections
  • Diagnosis of well-established neuroinflammatory disease such as MS (ICD codes G00–G09, G35–G37) or SLE (M32)
  • Tested positive for autoantibodies in serum or CSF associated to known and treatable neuroinflammatory disease (such as neuroborreliosis, treatable autoimmune encephalitis). Patients having completed recommended treatment without significant improvement may still be included in this study.
  • History of any illness that in the opinion of the investigator may jeopardize the ability of the patient to participate in the study.
See the full eligibility criteria
Who can join
  • Patients to be included in this study meet the criteria for at least one of the following ICD 10 CM diagnoses: o Obsessive-compulsive disorder ICD F42 or o Obsessive-compulsive behavior ICD R46.81 o Schizophrenia, delusional, and other non-mood psychotic disorders, namely  F20 Schizophrenia  F22 Delusional disorders  F23 Brief psychotic disorder  F25 Schizoaffective disorders  F28 Other psychotic disorder not due to a substance or known physiological condition  F29 Unspecified psychosis not due to a substance or known physiological condition
  • The clinical picture indicates active inflammatory activity (see specific criteria below), potential for rehabilitation and time from disease and/or episode debut is no longer than 10 years.
  • Acute (<12 weeks) or atypical debut, or episodes of any of the following: a. Symptoms of encephalopathy:  psychotic symptoms, including hallucinations, delusions, paranoia, disorganized speech, disorganized behavior  agitation, confusion  sudden change in personality as perceived by the social environment  drowsiness  loss of functions in daily life  cognitive problems (memory, speech, learning)  emotional dysregulation b. Focal neurological symptoms, e.g.  ataxia, dystonia, myoclonus, sensory losses, paresthesia c. Psychomotor anomaly,  e.g. retardation, catatonic symptoms, parkinsonism d. Loss of drive (sleep, appetite, libido, motivation) e. Obsessions, compulsions (OCD/OCB), f. Hypo- or hypervigilance (for e.g sounds, emotions, other peoples´ or own behavior) g. Sleeping disorders, AND
  • AND At least one of the following criteria: a. Prodromal phase with infection or symptoms of infection (fever, malaise, etc) b. Clinical improvement of psychiatric symptoms after treatment with anti-inflammatory medications other than antibody therapy (such as steroids, NSAIDs IVIG, plasmaphereses), or antibiotics c. Radiological evidence of neuroinflammation (MR) d. EEG pathology or witnessed epileptic seizure e. Biochemical evidence of inflammation, autoimmunity or blood-brain barrier dysfunction in blood or CSF samples, such as one of the following:  presence of oligoclonal bands  elevated CSF cell count  elevated albumin quotient, or elevated albumin in CSF  elevated IgG ratio  elevated levels of neurofilament f. Patient history of autoimmune disorder not associated with neuroinflammation, such as type 1 diabetes, rheumatoid arthritis, Sjögren´s syndrome, inflammatory bowel disease (IBD, comprising Crohn´s disease and ulcerative colitis), celiac disease, Grave´s disease, Hashimoto`s thyroiditis g. Biochemical indication of autoimmunity such as elevated serum anti-TPO, ANA, ANCA, RF or GAD antibodies, PANDAS panel with relationship to symptom development.
  • Age: 18-55
  • Severity: Clinical Global impression (CGI): Minimum score of “4 = Moderately ill”
  • Swedish or English proficiency
  • The patient has tried at least 2 standard psychiatric medications at maximal tolerable or maximal recommended dosage for his/her current condition over a period of 6 months, but has not improved significantly
  • Medication has been unchanged for at least one month prior to study start
  • Signed informed consent
  • Use of adequate contraception
  • Radiological evidence of brain atrophy and scarring are absent
What rules you out
  • Concomitant malignancies or previous malignancies within the last five years
  • Pregnancy at any time during the study
  • Known chronical significant bacterial/viral/fungal infections
  • Diagnosis of well-established neuroinflammatory disease such as MS (ICD codes G00–G09, G35–G37) or SLE (M32)
  • Tested positive for autoantibodies in serum or CSF associated to known and treatable neuroinflammatory disease (such as neuroborreliosis, treatable autoimmune encephalitis). Patients having completed recommended treatment without significant improvement may still be included in this study.
  • History of any illness that in the opinion of the investigator may jeopardize the ability of the patient to participate in the study.
  • Patient is enrolled in another medical trial.
  • Cannot comply with vaccination recommendations
  • History of severe allergic or anaphylactic reactions in conjunction with prior treatment with monoclonal antibodies
  • Prior antibody therapy including Rituximab (MabThera®/Rituxan®)
  • Patient has been treated with clozapine (which may have immunosuppressant effect), systemic corticosteroids or IVIG within 60 days prior to screening visit
  • Prior treatment with immunosuppressant medications (not including systemic corticosteroids and IVIG) for other medical condition
  • History of or positive screening for HIV, Tuberculosis, Hepatitis B and/or Hepatitis C (ever)
  • Heart disease such as previous heart attack, arrhythmia or heart failure, coronary insufficiency
  • Current drug, alcohol, or chemical abuse

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.