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A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
This study has been terminated.
( Insufficient subject recruitment. )

First Received on June 17, 2008.   Last Updated on March 11, 2009   History of Changes
Sponsor: TheraGenetics Limited
Information provided by: TheraGenetics Limited
ClinicalTrials.gov Identifier: NCT00701753
  Purpose

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
Schizophrenia
Schizoaffective Disorder

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics
MedlinePlus related topics: Mental Disorders Psychotic Disorders Schizophrenia
Drug Information available for: Risperidone Quetiapine Quetiapine fumarate Olanzapine
U.S. FDA Resources

Further study details as provided by TheraGenetics Limited:

Biospecimen Retention:   Samples With DNA

Whole blood DNA RNA


Enrollment: 24
Study Start Date: May 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Janet Munro, TheraGenetics Ltd
ClinicalTrials.gov Identifier: NCT00701753     History of Changes
Other Study ID Numbers: TheraGenetics-002
Study First Received: June 17, 2008
Last Updated: March 11, 2009
Health Authority: Canada: Health Canada

Keywords provided by TheraGenetics Limited:
Pharmacogenetic
DNA
RNA
Antipsychotic
 Olanzapine
Risperidone
Quetiapine
Personalized medicine

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 13, 2012



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