Recruiting · registry statusStudying immune problems associated with clozapine
Researchers investigate immune-system changes in people with Parkinson’s taking clozapine.
Testing a treatment or activity · Study reference: NCT06634641
Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓
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Looking for volunteers
- Start (reported actual date)
- 2024-10-01
- Main measurements finished (planned)
- 2027-09
- Study finished (planned)
- 2027-09
Planned dates can move. A study finishing does not tell us when a paper will be published.
No results summary has been confirmed in the registry records we imported. See connected papers below; we keep checking after recruitment ends.
Changes we have recorded
These are dates we observed a change, not necessarily the dates it happened.
Papers connected to this study
No connected paper has been found yet. The tracker checks the growing library for study identifiers and registry-linked publications.
Who can join?
Age 18 years and over · Does not accept healthy volunteers
These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.
Read all the rules for taking part
Sex eligibility reported by registry: all
Inclusion Criteria:
* Patient ≥ 18 years old with Parkinson's disease according to MDS 2015 criteria
* Psychotic symptoms requiring treatment with Clozapine
* 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 \[2 x 109/l\])
* patients in whom the number of white blood cells (WBC) and the absolute number of neutrophils (PNN) may be determined regularly at the following intervals: once a week during the first 18 weeks of treatment and, thereafter, at least every 4 weeks for the duration of the treatment. This monitoring must be continued throughout the treatment and for 4 weeks who follow the complete cessation of CLOZAPINE
* Informed and written consent.
* Affiliation to a social security system
Exclusion Criteria:
* Patients with a contraindication to the use of Clozapine according to the summary of product characteristics (SPC)
* Hypersensitivity to the active substance or to any of the excipients.
* Patients who cannot receive regular blood tests.
* History of granulopenia or toxic or idiosyncratic agranulocytosis (unless it results from previous chemotherapy).
* History of agranulocytosis induced by CLOZAPINE
* Treatment with CLOZAPINE should not be started at the same time as substances known to have a high potential for inducing agranulocytosis; The concomitant administration of depot antipsychotics is not recommended.
* Functional bone marrow failure.
* Uncontrolled epilepsy.
* Alcoholic or induced psychosis, drug intoxication, comatose states.
* Circulatory collapse and / or CNS depression regardless of the aetiology.
* Severe renal or cardiac disorders (eg: myocarditis).
* Active liver disease with nausea, anorexia or jaundice; progressive liver disease, liver failure.
* Paralytic ileus.
* Patient with another potential cause of immunosuppression
* Immunosuppressive or immune modulatory treatment active or stopped for less than 5 years
* Anti-epileptic treatment active or stopped for less than 5 years
* Chemotherapy active or stopped for less than 5 years
* Solid or hematologic cancer active or treated for less than 5 years
* Human immunodeficiency virus infection
* Already known constitutional immune deficiency
* Nephrotic syndrome
* Protein-losing enteropathy
* A history of radiotherapy
* Long-term use of corticosteroids
* Patient with potentially major cognitive disorders defined by a MoCA score less than or equal to 23
* Pregnant or breastfeeding women
* Patient under guardianship/curatorship or deprived of liberty
Full study name & original research details
Official study title
Assessment of Clozapine-related Immunodeficiency Effect in Parkinsons Disease Patients
Short title used by the registry
Clozapine-related Immunodeficiency in Parkinsons Disease
Original description
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 reported: Clozapine; Parkinson's Disease (PD); Immunodeficiency; Psychosis
Registry records for this study
Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.
- Study type
- Interventional
- Interventions
- blood test
- Phases
- PHASE4
- Sponsor
- Centre Hospitalier Universitaire, Amiens
- Start date reported by registry
- 2024-10-01 (actual)
Registry updated: 2025-11-19 · Status last verified by the registry submitter: 2025-11
Registry records retrieved 2026-10-13 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.
Contact the research team
Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.
Mickaël AUBIGNAT, MD · 33 + 03 22 66 82 40 · aubignat.mickael@chu-amiens.fr
Mickaël AUBIGNAT, MD · (33) + 03 22 66 82 40 · aubignat.mickael@chu-amiens.fr
Study locations
Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.
CHU Amiens-Picardie
Salouël, France
RecruitingMickaël AUBIGNAT, MD · 33 + 03 22 66 82 40 · aubignat.mickael@chu-amiens.fr
Facility not reported
France
Status not reportedThe original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.