SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02566057

Developed by Shray Alag, 2019.
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

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:
Bipolar affective disorder
Genes 23
COMT SEC24C POLG2 SLC25A4 ARVCF ATP2A2 CDH23 FLI1 MECP2 TWNK USP8 JMJD1C FA2H CHRNA7 TBX1 RRM2B POLG RPS6KA3 UFD1 HIRA GP1BB CLCN4 RREB1
Mania
Genes 23
COMT SEC24C POLG2 SLC25A4 ARVCF ATP2A2 CDH23 FLI1 MECP2 TWNK USP8 JMJD1C FA2H CHRNA7 TBX1 RRM2B POLG RPS6KA3 UFD1 HIRA GP1BB CLCN4 RREB1
Psychosis
Genes 94
NPC1 NHLRC1 MKRN3 SNORD115-1 CACNA1A SLC12A6 CLN8 TMEM106B USP8 PRDM8 EPM2A MAGEL2 PANK2 PSEN1 COX1 COX2 COX3 ACADS PDGFB PDGFRB MAPT ZDHHC9 ATXN7 WFS1 SOBP SQSTM1 SLC20A2 CLN3 PARK7 RPS6KA3 PCDH19 ND1 TBC1D7 ND4 ND5 SLC6A19 ND6 PAH VPS13A NPAP1 TREM2 DCAF17 IPW PRKAR1A PWRN1 PAK3 SPART ALDH18A1 CDH23 HMBS TWNK TRNF ZFYVE26 GRN NPC2 ALAD TRNH NDN NDP UPF3B ABCD1 TRNL1 AIP GNAS PWAR1 HERC2 TRNQ TRNS1 TRNS2 C9ORF72 SLC7A7 TRNW ITM2B ATP13A2 CBS ALDH5A1 MECP2 LMBRD1 KCNT1 SNRPN MED12 SH2B1 SNORD116-1 NAGS PRNP MYORG TTC19 VCP GSS CHMP2B DNMT1 PPOX PDE11A MKRN3-AS1
Schizophrenia
Genes 50
WHRN FLI1 GJA5 GJA8 DNAJC13 CIB2 ARSA PSAP COMT SEC24C CEP78 ARVCF MYO7A ZDHHC9 WFS1 USH1G KRT81 DISC2 KRT83 KRT86 VPS35 UFD1 EIF4G1 LRRK2 PCDH15 GBA CDH23 GIGYF2 TRNE PDZD7 DSG4 UPF3B ADGRV1 HARS SNCA TRNS2 RREB1 USH1C USH2A ATP2A2 CLRN1 JMJD1C MED12 MSTO1 CHRNA7 TBX1 ARSG PRODH HIRA GP1BB