CHU Amiens-Picardie
Salouël, 80480, France
Location status: Recruiting
NCT Number: NCT06634641
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 4
Salouël, 80480, France
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
≥ 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.
Time frame: 6 months
change in serum IgG levels after 6 months of clozapine treatment
Contact information is provided by the study sponsor or research team.
Mickaël AUBIGNAT, MD
CONTACT
33 + 03 22 66 82 40
Mickaël AUBIGNAT, MD
CONTACT
(33) + 03 22 66 82 40
Centre Hospitalier Universitaire, Amiens
Other
Assessment of Clozapine-related Immunodeficiency Effect in Parkinsons Disease Patients
Acronym: CLOZIDPD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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