A Phase 4 interventional study of blood test in Clozapine, Parkinson's Disease (PD) and Immunodeficiency, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 4, Interventional, and Treatment
Clozapine is a second generation antipsychotic drug used in psychiatry to treat schizophrenia, affective disorders or certain symptoms of dementia. In neurology, clozapine is frequently used and recommended to manage symptoms of psychosis associated with Parkinson's disease (PD). The risk of neutropenia or agranulocytosis associated with clozapine estimated at 1.3% is well known to doctors around the world with a peak at one month and a decrease in risk after more than a year of treatment. This risk has led to the policy of "no blood, no drugs" and monitoring of the complete blood count (CBC) weekly for 18 weeks and then monthly for the duration of treatment.
Some studies suggest an increased risk of infections related to immunodeficiency induced by clozapine itself. This clozapine-induced immunodeficiency would be comparable to that encountered in patients with common variable immunodeficiency or under immunosuppressive treatment. In addition, this immunosuppressive effect linked to clozapine would not be dose dependent but time dependent. However, the only studies currently performed have been in psychiatric patients treated for schizophrenia.
It seems important to specifically explore clozapine-related immunodeficiency in PD patients treated with clozapine for PD-related psychosis. In this study, the investigators propose to evaluate the variations in serum immunoglobulin levels and lymphocyte subpopulations (B, T, NK) in parkinsonian patients treated with Clozapine at 6 months and 1 year after initiation of treatment.
698 studies on the registry are indexed under Immunologic Deficiency Syndromes; 67 are open to participants now.
This study's planned enrollment of 24 is below the median of 56 across 455 interventional studies indexed under Immunologic Deficiency Syndromes.
Browse Immunologic Deficiency Syndromes studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
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Patients with initially a normal leukocyte count (number of white blood cells
≥ 3500/mm3 [3.5 x 109/l] and an absolute neutrophil count PNN ≥ 2000/mm3 [2 x 109/l])
Exclusion Criteria:
Only carrying out additional immunological assays during blood tests before initiation of treatment, six months after initiation of treatment and then one year after initiation of treatment.
change in serum IgG levels
change in serum IgG levels after 6 months of clozapine treatment
Time frame: 6 months
Plan to share: No
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Immunologic Deficiency Syndromes→
Centre Hospitalier Universitaire, Amiens