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

Sponsor:	TheraGenetics Limited
Information provided by:	TheraGenetics Limited
ClinicalTrials.gov Identifier:	NCT00701753

Purpose

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.

Condition
Schizophrenia Schizoaffective Disorder

Study Type:	Observational
Study Design:	Case-Only
Official Title:	A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses

Resource links provided by NLM:

MedlinePlus related topics: Psychotic Disorders Schizophrenia

U.S. FDA Resources

Further study details as provided by TheraGenetics Limited:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Whole blood DNA RNA

Enrollment:	24
Study Start Date:	May 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
Olanzapine Subjects treated with olanzapine as part of their routine clinical care
Risperidone Subjects treated with risperidone as part of their routine clinical care
Quetiapine Subjects treated with quetiapine as part of their routine clinical care

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients of Vancouver Coastal Health

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701753

Locations

Canada, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia, Canada

Sponsors and Collaborators

TheraGenetics Limited

Investigators

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

More Information

No publications provided

Responsible Party:	TheraGenetics Ltd ( Dr Janet Munro )
Study ID Numbers:	TheraGenetics-002
Study First Received:	June 17, 2008
Last Updated:	March 11, 2009
ClinicalTrials.gov Identifier:	NCT00701753 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by TheraGenetics Limited:

Pharmacogenetic
DNA
RNA
Antipsychotic

Olanzapine
Risperidone
Quetiapine
Personalized medicine

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 09, 2009