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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.
ClinicalTrials.gov Identifier: NCT00701753
Recruitment Status : Terminated (Insufficient subject recruitment.)
First Posted : June 19, 2008
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:

Study Description
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 Design

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
Primary Completion Date : March 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Biospecimen Retention:   Samples With DNA
Whole blood DNA RNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Janet Munro, TheraGenetics Ltd
ClinicalTrials.gov 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:
Pharmacogenetic
DNA
RNA
Antipsychotic
Olanzapine
Risperidone
Quetiapine
Personalized medicine

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Antipsychotic Agents
Olanzapine
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
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators