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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

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 28
TWNK RPS6KA3 TBX1 GP1BB HIRA RRM2B ARVCF FA2H SEC24C DNMT3A ATP2A2 MECP2 POLG2 CLCN4 CHRNA7 FLI1 JMJD1C SMPD1 RREB1 USP8 CDH23 CLCN4 TBX1 COMT POLG UFD1 TBX1 SLC25A4
Mania
Genes 29
TWNK RPS6KA3 TBX1 GP1BB HIRA RRM2B ARVCF FA2H SEC24C DNMT3A ATP2A2 MECP2 POLG2 CLCN4 CHRNA7 FLI1 JMJD1C SMPD1 RREB1 USP8 CDH23 SLC25A13 CLCN4 TBX1 COMT POLG UFD1 TBX1 SLC25A4
Psychosis
Genes 116
TWNK SNRPN GRN NAGS SNORD116-1 SLC7A7 PRKAR1A UPF3B TREX1 TREM2 TRNH WFS1 IPW CLN8 ALDH5A1 SPART PCDH19 ND4 AIP NPAP1 LMBRD1 TRNL1 MKRN3 SLC25A13 PSEN1 ABCD1 MECP2 C1R TRNQ NDP RPS6KA3 PTPN22 ZDHHC9 STAT4 ATXN7 TRNS2 PRDM8 VCP HMBS GSS DCAF17 PARK7 FCGR2B PDE11A ITM2B TBC1D7 ZFYVE26 SPP1 TRNS1 PANK2 SQSTM1 CTLA4 PDGFB PWRN1 USP8 MED12 SLC20A2 HFE NPC2 NHLRC1 SLC12A6 C9ORF72 NDN COX1 CHMP2B MAGEL2 CBS MKRN3-AS1 EPM2A TRNF VPS13A PAH ALDH18A1 PAK3 NPC1 ND1 USP8 TMEM106B PWAR1 MAPT PDGFB KCNT1 TRNW COX3 NDP ALAD GCLC CDH23 PCDH19 C1QA C9ORF72 PRNP CLN3 MYORG COX2 DNASE1 PPOX SLC6A19 SOBP DCAF17 SNORD115-1 WFS1 IRAK1 FCGR2A ND6 TTC19 SH2B1 MED12 GNAS DNMT1 ND5 CACNA1A ACADS HERC2 PDGFRB ATP13A2
Schizophrenia
Genes 71
USH1C RTN4R USH1G HIRA UPF3B GJA5 DNAJC13 DNMT3A KRT86 HTR2A APOL4 CLRN1 DRD3 CEP78 ARSG MSTO1 TRNE PRODH RREB1 GIGYF2 PDZD7 MTHFR RBM12 ADGRV1 NKX2-1 TRNS2 KRT83 SNCA MYO7A COMT CIB2 PCDH15 WHRN TBX1 GP1BB DSG4 ZDHHC9 ARSA ARVCF WFS1 PRODH PSAP APOL2 SEC24C KRT81 LRRK2 CHI3L1 MYO7A ATP2A2 SHANK3 SYN2 EIF4G1 CHRNA7 GBA FLI1 MED12 VPS35 JMJD1C MSTO1 USH2A AKT1 GJA8 TBX1 COMT UFD1 PRODH DISC2 TBX1 HARS1 CDH23 DAOA