Clozapine-related Immunodeficiency in Parkinsons Disease

NCT06634641 | Recruiting Phase 4

• 1 other identifier: PI2024_843_0069
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clozapine; Parkinson's Disease (PD); Immunodeficiency; Psychosis

Keywords

clozapine; parkinson's disease; immunodeficiency; psychosis

Outcome Measures

Primary Outcomes (1)

• change in serum IgG levels

  change in serum IgG levels after 6 months of clozapine treatment

  6 months

Interventions

blood test BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Salouël, 80480, France

RECRUITING

MeSH Terms

Conditions

Immunologic Deficiency Syndromes; Psychotic Disorders

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Immune System Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Mickaël AUBIGNAT, MD

CONTACT

33 + 03 22 66 82 40; aubignat.mickael@chu-amiens.fr

Mickaël AUBIGNAT, MD

CONTACT

(33) + 03 22 66 82 40; aubignat.mickael@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)