Clinical trial NCT00701753: A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
Official title: A Pharmacogenetic Investigation of Antipsychotics in Schizophrenia and Schizophrenia-Like Psychoses
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Pharmacogenetic
DNA
RNA
Antipsychotic
Olanzapine
Risperidone
Quetiapine
Personalized medicine
Lead sponsor: TheraGenetics Limited
Sponsor class: INDUSTRY
First posted: 2008-06-19
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of Vancouver Coastal Health

Brief 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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver Coastal Health
state: British Columbia
Study officials:
affiliation: Vancouver Coastal Health
name: Soma Ganesan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TheraGenetics Limited
name: Janet Munro, MB BS
role: STUDY_DIRECTOR
References: