A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
NCT ID: NCT00701753
Last Updated: 2009-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
24 participants
OBSERVATIONAL
2008-05-31
2009-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
Study Groups
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Olanzapine
Subjects treated with olanzapine as part of their routine clinical care
No interventions assigned to this group
Risperidone
Subjects treated with risperidone as part of their routine clinical care
No interventions assigned to this group
Quetiapine
Subjects treated with quetiapine as part of their routine clinical care
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
65 Years
ALL
No
Sponsors
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TheraGenetics Limited
INDUSTRY
Responsible Party
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TheraGenetics Ltd
Principal Investigators
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Soma Ganesan, MD
Role: PRINCIPAL_INVESTIGATOR
Vancouver Coastal Health
Janet Munro, MB BS
Role: STUDY_DIRECTOR
TheraGenetics Limited
Locations
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Vancouver Coastal Health
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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TheraGenetics-002
Identifier Type: -
Identifier Source: org_study_id
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