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

NCT00701753 | Terminated

• 1 other identifier: TheraGenetics-002
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Pharmacogenetic; DNA; RNA; Antipsychotic; Olanzapine; Risperidone; Quetiapine; Personalized medicine

Study Arms (3)

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 Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients of Vancouver Coastal Health

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• TheraGenetics Limited: lead

Study Sites (1)

Vancouver Coastal Health

Vancouver, British Columbia, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood DNA RNA

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Soma Ganesan, MD

  Vancouver Coastal Health

  PRINCIPAL INVESTIGATOR

• Janet Munro, MB BS

  TheraGenetics Limited

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 19, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: March 12, 2009

Record last verified: 2009-03

Locations

CA (1)