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

• Conditions: SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDERS AND BIPOLAR DISORDERS WITH PSYCHOTIC FEATURES; MedDRA version: 9.1Level: SOCClassification code 10037175Term: Psychiatric disorders

• Registration Number: EUCTR2007-003867-36-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.