Actively Recruiting
Clozapine-related Immunodeficiency in Parkinsons Disease
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-11-19
24
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 according to MDS 2015 criteria
- Psychotic symptoms requiring treatment with Clozapine
- Initially normal leukocyte count (white blood cells 235000/mm3 [3.5 x 10^9/l]) and absolute neutrophil count (PNN 22000/mm3 [2 x 10^9/l])
- Ability to have white blood cell and neutrophil counts measured regularly: weekly for the first 18 weeks, then at least every 4 weeks during treatment, and continued for 4 weeks after stopping Clozapine
- Informed and written consent
- Affiliation to a social security system
You will not qualify if you...
- Contraindication to Clozapine according to product characteristics
- Hypersensitivity to Clozapine or its components
- Inability to receive regular blood tests
- History of granulopenia or toxic/idiosyncratic agranulocytosis (unless due to chemotherapy)
- History of agranulocytosis induced by Clozapine
- Starting Clozapine with substances known to cause agranulocytosis; depot antipsychotics not recommended concurrently
- Functional bone marrow failure
- Uncontrolled epilepsy
- Alcoholic or induced psychosis, drug intoxication, or comatose states
- Circulatory collapse or CNS depression of any cause
- Severe renal or cardiac disorders (e.g., myocarditis)
- Active or progressive liver disease with symptoms
- Paralytic ileus
- Other potential causes of immunosuppression
- Immunosuppressive or immune modulatory treatment active or stopped less than 5 years ago
- Anti-epileptic treatment active or stopped less than 5 years ago
- Chemotherapy active or stopped less than 5 years ago
- Active or recent solid or hematologic cancer (within 5 years)
- HIV infection
- Known constitutional immune deficiency
- Nephrotic syndrome
- Protein-losing enteropathy
- History of radiotherapy
- Long-term corticosteroid use
- Major cognitive disorders (MoCA score 23 or less)
- Pregnant or breastfeeding women
- Patients under guardianship, curatorship, or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CHU Amiens-Picardie
Salouël, France, 80480
Actively Recruiting
Research Team
M
Mickaël AUBIGNAT, MD
CONTACT
M
Mickaël AUBIGNAT, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here