Effect of Genotyping for CYP450 Polymorphisms Versus Intense Clinical Monitoring on Antipsychotic Drug Treatment

Not Applicable

Completed

• Conditions: Schizophrenia

• Registration Number: NCT00707382
• Lead Sponsor: Gesche Jurgens

Brief Summary

The purpose of this study is to determine whether genotyping for CYP2D6 and 2C19 polymorphisms or intense clinical monitoring of treatment and adverse effects improves the antipsychotic treatment in patients with schizophrenia. This study is designed as a three-armed prospective randomized controlled clinical trial and includes 300 patients with schizophrenia. Patients are followed for a period of one year.

During the study period the following effect measures are registered:

* Time to discontinuation of all antipsychotic medications

* Number of changes in medication dose

* Number of changes in medication

* Compliance (patients´ adherence to medical treatment)

* Clinical symptoms

* Adverse effects

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-26
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-06-30
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-09
• Last Update Posted: 2012-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

• Diagnosed with schizophrenia
• Able to give written informed consent

Exclusion Criteria

• Genotyped prior to inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to discontinuation of initial antipsychotic treatment	one year

Secondary Outcome Measures

Name	Time	Method
Compliance	one year

Trial Locations

Locations (1)

Department of Clinical Pharmacology, Bispebjerg Hospital and Research Unit, Psychiatric Centre Bispebjerg; 🇩🇰 Copenhagen, Denmark