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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00701753
Recruitment Status : Terminated (Insufficient subject recruitment.)
First Posted : June 19, 2008
Last Update Posted : March 12, 2009
Information provided by:
TheraGenetics Limited

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.

Condition or disease
Schizophrenia Schizoaffective Disorder

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case-Only
Official Title: A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
Study Start Date : May 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

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

Biospecimen Retention:   Samples With DNA
Whole blood DNA RNA

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients of Vancouver Coastal Health

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00701753

Canada, British Columbia
Vancouver Coastal Health
Vancouver, British Columbia, Canada
Sponsors and Collaborators
TheraGenetics Limited
Principal Investigator: Soma Ganesan, MD Vancouver Coastal Health
Study Director: Janet Munro, MB BS TheraGenetics Limited

Responsible Party: Dr Janet Munro, TheraGenetics Ltd Identifier: NCT00701753     History of Changes
Other Study ID Numbers: TheraGenetics-002
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by TheraGenetics Limited:
Personalized medicine

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators