Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634641
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Clozapine-related Immunodeficiency in Parkinson39s Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Assessment of Clozapine-related Immunodeficiency Effect in Parkinson39s Disease Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLOZIDPD
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 Parkinsons disease PD The risk of neutropenia or agranulocytosis associated with clozapine estimated at 13 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None