RecruitingPhase 4NCT06634641

Clozapine-related Immunodeficiency in Parkinsons Disease

Assessment of Clozapine-related Immunodeficiency Effect in Parkinsons Disease Patients


Sponsor

Centre Hospitalier Universitaire, Amiens

Enrollment

24 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether clozapine — a medication used to treat psychosis in Parkinson's disease patients — causes immune system suppression (reduced white blood cell counts) in this specific group of patients. Clozapine can lower white blood cell counts, which increases infection risk, and researchers want to understand how this happens and who is most at risk. **You may be eligible if...** - You are 18 or older and have Parkinson's disease - You experience psychotic symptoms (hallucinations, delusions) that require clozapine treatment - Your white blood cell counts are normal at the start of treatment - You can have regular blood monitoring (weekly for the first 18 weeks, then monthly) - You are enrolled in the French social security system and can give written consent **You may NOT be eligible if...** - You have a known contraindication to clozapine - You have a history of dangerously low white blood cell counts (agranulocytosis), especially from clozapine - You have another condition causing immune suppression (HIV, active cancer, nephrotic syndrome, etc.) - You are on immunosuppressive or anti-epileptic medications - You have significant cognitive impairment (MoCA score of 23 or less) - You are pregnant or breastfeeding - You are under legal guardianship or in custody Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALblood test

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.


Locations(1)

CHU Amiens-Picardie

Salouël, France

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NCT06634641


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