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PILOT STUDY OF PHARMACOGENETICS, CLINICAL EFFICACY AND TOLERABILITY OF CLOZAPINE IN PATIENTS AFFECTED BY SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDERS AND BIPOLAR DISORDERS WITH PSYCHOTIC FEATURES - ND

PILOT STUDY OF PHARMACOGENETICS, CLINICAL EFFICACY AND TOLERABILITY OF CLOZAPINE IN PATIENTS AFFECTED BY SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDERS AND BIPOLAR DISORDERS WITH PSYCHOTIC FEATURES - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003867-36-IT
Enrollment
Unknown
Registered
2007-10-09
Start date
2007-07-18
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDERS AND BIPOLAR DISORDERS WITH PSYCHOTIC FEATURES MedDRA version: 9.1 Level: SOC Classification code 10037175 Term: Psychiatric disorders

Interventions

Trade Name: LEPONEX 25*28CPR 25MG Pharmaceutical Form: Tablet INN or Proposed INN: Clozapine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-

Sponsors

AZIENDA OSPEDALIERA PISANA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Age greater than 18 years and lower than 65 years. Diagnosis of schizophrenia, schizoaffective disorders and bipolar disorders with psychotic features (DSM-IV criteria). Treatment with clozapine since at least 14 days. Patients? agreement to follow up with measurement of clozapine and norclozapine plasma levels. Signature of written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Age lower than 18 years or higher than 65 years. Epatic or renal failure. Cardiopathies. Parkinson?s disease; Epilepsy and predisposing conditions. Depressive disorders. Myasthenia gravis. Paralytic ileus. Prostate hyperplasia. Familial or personal case history of glaucoma. Respiratory diseases. Familial or personal case history of jaundice or hematological diseases. Familial or personal case history of photosensitization. Personal case history of substance abuse in the last year. Pregnancy or breast-feeding.

Design outcomes

Primary

MeasureTime frame
Main Objective: 1) Evaluation of clinical efficacy and tolerability of clozapine in patients affected by schizophrenia, schizoaffective disorders and bipolar disorders with psychotic features.;Secondary Objective: 2) Analysis of polymorphisms of ABCB1, 5-HT2A, DRD2, measurement of plasma levels of clozapine and its active metabolite norclozapine. 3) Analysis of correlations among patients? genotype (polymorphisms), plasma levels of clozapine and norclozapine and efficacy and tolerability of treatment.;Primary end point(s): a) Evaluation of clinical efficacy and tolerability to clozapine by using appropriate scales.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026