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

NCT ID: NCT00701753

Last Updated: 2009-03-12

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Observational Model Type

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

* 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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TheraGenetics Limited

INDUSTRY

Sponsor Role lead

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

Site Status

Countries

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Canada

Other Identifiers

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TheraGenetics-002

Identifier Type: -

Identifier Source: org_study_id

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