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

This study has been terminated.
(Insufficient subject recruitment.)
Sponsor:
Information provided by:
TheraGenetics Limited
ClinicalTrials.gov Identifier:
NCT00701753
First received: June 17, 2008
Last updated: March 11, 2009
Last verified: March 2009

June 17, 2008
March 11, 2009
May 2008
March 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00701753 on ClinicalTrials.gov Archive Site
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Not Provided
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A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses

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.

Not Provided
Observational
Observational Model: Case-Only
Not Provided
Retention:   Samples With DNA
Description:

Whole blood DNA RNA

Non-Probability Sample

Patients of Vancouver Coastal Health

  • Schizophrenia
  • Schizoaffective Disorder
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
19 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00701753
TheraGenetics-002
No
Dr Janet Munro, TheraGenetics Ltd
TheraGenetics Limited
Not Provided
Principal Investigator: Soma Ganesan, MD Vancouver Coastal Health
Study Director: Janet Munro, MB BS TheraGenetics Limited
TheraGenetics Limited
March 2009

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