A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
Information source: TheraGenetics Limited
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Schizoaffective Disorder
Phase: N/A
Status: Recruiting
Sponsored by: TheraGenetics Limited Official(s) and/or principal investigator(s):
Soma Ganesan, MD, Principal Investigator, Affiliation: Vancouver Coastal Health
Janet Munro, MB BS, Study Director, Affiliation: TheraGenetics Limited
Overall contact:
Soma Ganesan, MD, Phone: 604-875-4023, Email: soma.ganesan@vch.ca
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.
Clinical Details
Official title: A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
Study design: Case-Only, Other
Eligibility
Minimum age: 19 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Soma Ganesan, MD, Phone: 604-875-4023, Email: soma.ganesan@vch.ca
Vancouver Coastal Health, Vancouver, British Columbia, Canada; Recruiting
Soma Ganesan, MD, Phone: 604-875-4023, Email: soma.ganesan@vch.ca
Soma Ganesan, MD, Principal Investigator
Additional Information
Starting date: May 2008
Ending date: April 2009
Last updated: June 17, 2008
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