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Assessment of clozapine-related immunodeficiency effect in Parkinson's disease patients (CLOZIDPD)

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514530-21-00
Enrollment
24
Registered
2024-08-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Brief summary

change in serum IgG levels before initiation of treatment with clozapine and then 6 months after initiation of treatment.

Detailed description

The variation in the patient's weight (weighed during visits D0, M6 and M12), The number of infections presented by the patient (oral collection during visits to M6 and M12), The use of antibiotics by the patient (oral collection during visits to M6 and M12), Tolerance / adverse effects of treatment with Clozapine (collected during visits to M6 and M12), Variation in motor status, quality of life, depressive syndrome, apathy, global cognitive efficiency and psychotic elements assessed on the clinical scales MDS-UPDRS, PDQ39, Goldberg, Starkstein, MoCA and the neuropsychological inventory (NPI) (carried out during visits D0, M6 and M12)., - Variation in serum IgA level (on blood test taken on D0, M6 and M12), Variation in serum IgM level (on blood test taken on D0, M6 and M12), Variation in IgG levels with the IgG1, IgG2, IgG3 and IgG4 subclasses (on blood samples taken on D0, M6 and M12), Variation in CBC parameters (on blood test taken on D0, M6 and M12), Variation in CRP level (on blood test taken on D0, M6 and M12), Change in serum Clozapine level (on blood test taken at M6 and M12), Variation in T, B and NK lymphocyte subpopulations (on blood samples taken on D0, M6 and M12)

Interventions

DRUGCLOZAPINE

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
change in serum IgG levels before initiation of treatment with clozapine and then 6 months after initiation of treatment.

Secondary

MeasureTime frame
The variation in the patient's weight (weighed during visits D0, M6 and M12), The number of infections presented by the patient (oral collection during visits to M6 and M12), The use of antibiotics by the patient (oral collection during visits to M6 and M12), Tolerance / adverse effects of treatment with Clozapine (collected during visits to M6 and M12), Variation in motor status, quality of life, depressive syndrome, apathy, global cognitive efficiency and psychotic elements assessed on the clinical scales MDS-UPDRS, PDQ39, Goldberg, Starkstein, MoCA and the neuropsychological inventory (NPI) (carried out during visits D0, M6 and M12)., - Variation in serum IgA level (on blood test taken on D0, M6 and M12), Variation in serum IgM level (on blood test taken on D0, M6 and M12), Variation in IgG levels with the IgG1, IgG2, IgG3 and IgG4 subclasses (on blood samples taken on D0, M6 and M12), Variation in CBC parameters (on blood test taken on D0, M6 and M12), Variation in CRP level (on bl

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026