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

TheraGenetics

Status: Terminated

Conditions: Schizophrenia; Schizoaffective Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT00701753

TheraGenetics-002

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 3 patient groups

Olanzapine

Description:

Subjects treated with olanzapine as part of their routine clinical care

Risperidone

Description:

Subjects treated with risperidone as part of their routine clinical care

Quetiapine

Description:

Subjects treated with quetiapine as part of their routine clinical care