A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses - Tabular View

Tracking Information

First Received Date ^ICMJE

June 17, 2008

Last Updated Date

March 11, 2009

Start Date ^ICMJE

May 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00701753 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses

Official Title ^ICMJE

A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses

Brief Summary

An individual's genetic make-up is known to determine their response to antipsychotic medication. Genetic markers that determine efficacy and side effects of medication may be identified and used to predict treatment outcome.

The study is a naturalistic study of routinely prescribed antipsychotics using outcome measures undertaken as part of the routine clinical care of the cohort. These clinical data are linked with genetic information obtained from DNA and RNA from blood samples undertaken as part of the study.

No alteration is made to the subjects treatment regime or medication.

The study is a two stage investigation:

The first stage involves the collection of a databank of clinical information and blood samples for DNA and RNA extraction from patients treated with antipsychotic medication.
The second stage is a molecular genetic investigation of treatment-related genetic factors that may contribute to response prediction and predisposition to side effects.

From these genetic studies pharmacogenetic prediction tests will be validated and/or developed.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case-Only, Other

Condition ^ICMJE

Schizophrenia
Schizoaffective Disorder

Intervention ^ICMJE

Study Arms / Comparison Groups

Subjects treated with olanzapine as part of their routine clinical care
Subjects treated with risperidone as part of their routine clinical care
Subjects treated with quetiapine as part of their routine clinical care

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Written informed consent must be obtained
DSM-IV diagnosis must be one of:
- schizophrenia
- schizophreniform
- schizoaffective
- delusional disorder
- brief reactive psychosis
- psychosis not otherwise specified
Ethnic origin of both parents must be known
A minimum of 6 weeks continuous treatment completed with the given antipsychotic, prescribed at least at minimum recommended doses
Prospectively collected outcome data available (pre-treatment and after at least 6 weeks on treatment)

Exclusion criteria:

Significant psychiatric or medical co-morbidity including history of:
- head injury with loss of consciousness
- seizures
- neurological disorder
- mental retardation (DSM-IV)
- drug or alcohol dependence (DSM-IV)
- serious physical illness e.g. malignancy, hepatic/renal insufficiency
Concomitant psychotropic medication that may influence ratings
Concomitant antipsychotics, antidepressants or mood stabilisers prescribed for >2 weeks during the antipsychotic treatment period rated

Gender

Both

Ages

19 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT ID ^ICMJE

NCT00701753

Responsible Party

Dr Janet Munro, TheraGenetics Ltd

Study ID Numbers ^ICMJE

TheraGenetics-002

Study Sponsor ^ICMJE

TheraGenetics Limited

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Soma Ganesan, MD	Vancouver Coastal Health
Study Director:	Janet Munro, MB BS	TheraGenetics Limited

Information Provided By

TheraGenetics Limited

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP