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Report for Clinical Trial NCT02566057

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Prospective Pharmacogenetic Testing and Clinical Outcomes in Patients With Early-Phase Psychosis

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

NCT02566057 Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Psychotic Disorders Bipolar Disorder
MeSH:Disease Schizophrenia Bipolar Disorder Psychotic Disorders Mental Disorders
HPO:Bipolar affective disorder Mania Psychosis Schizophrenia

1 Interventions

Name: PGx testing guided treatment (PGT)

Description: 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.
Type: Biological
Group Labels: 1

PGx testing guided treatment (PGT)


Primary Outcomes

Description: Due to lack of efficacy or intolerability

Measure: Time to Discontinuation of First Medication

Time: 12 months

Secondary Outcomes

Description: The clinician is asked to fill out a questionnaire elaborating the medication decision-making process for each patient, including whether or not acting on the genetic information provided clinically relevant information.

Measure: Prescribing Behavior Change Based on the Results of the Pharmacogenetic Testing

Time: 12 months

Other Outcomes

Description: Assessed by Brief Psychiatric Rating Scale (BPRS)

Measure: Treatment Efficacy

Time: 12 months

Description: Assessed by measures including Hillside Adverse Events Rating Scale (HAERS), Simpson-Angus Rating Scale for Extrapyramidal Symptoms (SARSES), Barnes Rating Scale for Drug-Induced Akathisia (BRSDIA), Abnormal Involuntary Movement Scale (AIMS)

Measure: Adverse Drug Response

Time: 12 months

Description: Examine overall medical costs (including outpatient visits, procedures, hospitalizations, other professional charges, laboratory charges, and medication costs), as well as costs specifically associated with treatment of psychiatric symptoms based upon ICD9 code (for procedures and visits) and medication category. This information will be provided by insurance company for patients with ValueOptions insurance coverage.

Measure: Treatment Services Utilized

Time: 12 months

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 rs1799732

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.


2 rs3813929

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.



HPO Nodes


HPO: