Prospective Pharmacogenetic Testing and Clinical Outcomes in Patients With Early-Phase Psychosis
Condition: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Psychotic Disorders
Study type: Interventional

Summary: 
      This study evaluates whether prospective pharmacogenetic testing is cost-effective in
      affecting clinical treatment outcomes in patients with early-phase psychosis.
    

Detailed description: 
      Large scale clinical trials have demonstrated that a substantial proportion of patients with
      psychotic disorders, such as schizophrenia and bipolar disorder, discontinue their
      antipsychotic medications due to either lack of efficacy or intolerable side effects, such as
      extrapyramidal symptoms (EPS) and weight gain. In clinical practice, it is essentially a
      trial and error process in deciding the best antipsychotic drug to start or switch to after a
      failed trial as there is little empirical data available to guide clinicians in drug
      selection. One promising tool, which can potentially provide valuable information to help
      guide medication management, is pharmacogenetic testing of certain genetic variants that are
      associated with psychiatric drug response. However, most pharmacogenetic studies to date have
      been retrospective, and there is no prospective clinical trial evaluating the clinical
      utility of pharmacogenetic testing in guiding clinical practice. Furthermore, it is unknown
      whether pharmacogenetic testing is cost effective.

      Until recently, pharmacogenetic testing has been expensive and time-consuming. New technology
      in the past few years makes it possible for cheaper and faster testing. One of the companies
      that offer pharmacogenetic testing services, Genomind LLC, provides genotyping of variants
      (GeneceptTM Assay) that are relevant to psychiatric drug response. For example, the serotonin
      2C receptor gene (HTR2C) has variants that protect patients from antipsychotic drug induced
      weight gain (-759C/T, rs3813929); a deletion variant of the dopamine D2 receptor gene (DRD2)
      suggests poor efficacy with antipsychotic drug treatment (-141C Ins/Del, rs1799732); the
      short allele of the serotonin transporter gene (SLC6A4) is associated with antidepressant
      side effects.

      In the present study, investigators propose to conduct a prospective, randomized,
      rater-blinded clinical trial to test the clinical utility and cost-effectiveness of
      pharmacogenetic testing in guiding medication treatment in patients with recent-onset
      psychotic disorders. Patients will be assigned to either a pharmacogenetic testing guided
      treatment condition (PGT) or a treatment as usual condition (TAU). In the PGT condition,
      patients will utilize the GeneceptTM Assay and results will be provided to their prescribers
      who may use the results to guide medication management. In the TAU condition, patients will
      also utilize the GeneceptTM Assay but the results will not be provided back to their
      prescribers, who will treat the patients without the knowledge of pharmacogenetic testing
      results.

      Pharmacogenetic testing may be more relevant in recent-onset or early stage illnesses because
      past medication history that is typically used to guide medication choice may not be
      available. Pharmacogenomic testing may be particularly pertinent to younger patients because
      they tend to be medication naïve and do not have previous medication history to guide future
      treatment. Pharmacogenomic testing may provide valuable information to guide medication
      choice in clinical practice.
    

Intervention name(s): PGx testing guided treatment (PGT)
Intervention type(s): Biological
Intervention description(s): Genecept Assay (GeneceptTM Assay) will provide information on genotypes of genetic variants that are relevant to psychiatric drug response. The provider can use the information to decide on which psychotropic drugs to use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment