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Clinical Trials/EUCTR2007-003867-36-IT
EUCTR2007-003867-36-IT
Active, not recruiting
Not Applicable

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

AZIENDA OSPEDALIERA PISANA0 sitesOctober 9, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SCHIZOPHRENIA, SCHIZOAFFECTIVE DISORDERS AND BIPOLAR DISORDERS WITH PSYCHOTIC FEATURES
Sponsor
AZIENDA OSPEDALIERA PISANA
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 9, 2007
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERA PISANA

Eligibility 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

  • 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.

Outcomes

Primary Outcomes

Not specified

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