Actively Recruiting
Assessment of Clozapine-related Immunodeficiency Effect in Parkinson's Disease Patients
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-19
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of clozapine, a second-generation antipsychotic drug used to treat psychosis in Parkinson's disease (PD) patients. The study focuses on clozapine-related immunodeficiency, which may cause decreased immune function and increased infection risk over time. This research aims to explore changes in immune system markers in PD patients treated with clozapine, as current data mainly involve psychiatric patients with schizophrenia. Participants will undergo blood tests to measure serum immunoglobulin levels and lymphocyte subpopulations (B, T, NK cells) at the start of clozapine treatment, six months later, and again at one year. The study involves regular monitoring of blood counts weekly for the first 18 weeks and then monthly while on treatment, continuing for four weeks after stopping clozapine. Additional immunological assays are added during these scheduled blood tests. Participants will be monitored through blood tests and clinical assessments during the study. Researchers will evaluate changes in serum IgG levels after six months as the primary outcome. The study will also track immune cell populations over time. Safety monitoring includes regular blood count checks to detect potential risks like neutropenia. The total follow-up extends at least one year after treatment initiation, allowing thorough observation of immune changes.
CONDITIONS
Brief Title
Clozapine-related Immunodeficiency in Parkinsons Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient 18 years or older with Parkinson's disease diagnosed by MDS 2015 criteria
- Presence of psychotic symptoms requiring clozapine treatment
- Normal initial white blood cell count (WBC 3500/mm3) and absolute neutrophil count (PNN 2000/mm3)
- Ability to have regular blood tests weekly for the first 18 weeks and then at least every 4 weeks during treatment
- Able to provide informed and written consent
- Affiliated with a social security system
You will not qualify if you...
- Contraindication to clozapine according to product guidelines
- Allergy to clozapine or any excipients
- Inability to have regular blood tests
- History of granulopenia or agranulocytosis unrelated to chemotherapy
- Previous clozapine-induced agranulocytosis
- Starting clozapine with drugs known to cause agranulocytosis
- Concomitant depot antipsychotic use not recommended
- Functional bone marrow failure
- Uncontrolled epilepsy
- Alcoholic or drug-induced psychosis, comatose states
- Circulatory collapse or central nervous system depression
- Severe kidney or heart problems including myocarditis
- Active or progressive liver disease
- Paralytic ileus
- Other causes of immunosuppression
- Recent or ongoing immunosuppressive, anti-epileptic, or chemotherapy treatments within 5 years
- Active or recent cancer within 5 years
- HIV infection
- Known constitutional immune deficiency
- Nephrotic syndrome or protein-losing enteropathy
- History of radiotherapy
- Long-term corticosteroid use
- Major cognitive disorder (MoCA score 23)
- Pregnant or breastfeeding women
- Under guardianship, curatorship, or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive clozapine treatment and have additional immunological blood tests before starting treatment, at six months, and at one year after starting treatment.
Blood tests before treatment, at 6 months, and at 12 months; weekly blood tests for the first 18 weeks, then at least every 4 weeks during treatment
Trial Site Locations
Total: 1 location
1
CHU Amiens-Picardie
Salouël, France, 80480
Actively Recruiting
Research Team
M
Mickaël AUBIGNAT, MD
M
Mickaël AUBIGNAT, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
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