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Report for Clinical Trial NCT03671525

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Cognitive Effects of Nimodipine in Patients With Schizophrenia

This study aims to evaluate the acute effects of nimodipine on cognitive performance in patients with schizophrenia using a battery of cognitive assessments.The subjects will also complete a 30-minute structural and functional MRI scan, with the goal of linking brain activity with working memory performance. Investigators predict that the performance increase induced by nimodipine will be greater in subjects who carry the A allele for the Calcium Voltage-Gated Channel Subunit Alpha1 C (CACNA1C) risk single nucleotide polymorphism (SNP) (rs1006737) in comparison to the response of G carriers.

NCT03671525 Schizophrenia Schizo Affective Disorder
MeSH: Schizophrenia Mood Disorders Psychotic Disorders
HPO: Psychosis Schizophrenia

2 Interventions

Name: Nimodipine

Description: Subject will receive two 30mg capsules of nimodipine during study visit.

Type: Drug

Nimodipine

Name: Placebo oral capsule

Description: Two coconut oil capsules that mimic the size and color of the nimodipine capsules

Type: Drug

Placebo


Primary Outcomes

Description: participants will complete an MRI scan to link brain activity with cognitive performance. Measures will be recorded in Arbitrary units.

Measure: Brain activity as assessed by BOLD fMRI

Time: between 30 min and 1 hour after dose

Description: Participants will complete the Brief Visuospatial Memory Task - Revised (BVMT-R) before and after administration of drug or placebo to determine the effect of nimodipine on visuospatial memory in patients with schizophrenia. Scores range from 0 to 60, with higher values indicating better performance. Administration takes approximately 45 minutes to complete (including a 25 minute delay)

Measure: Changes in Visual Learning and Memory Score

Time: approximately an hour after dose

Description: During each study visit, participants will complete the Hopkins Verbal Learning Task - Revised (HVLT-R) before and after administration of drug or placebo to determine the effect of nimodipine on verbal learning and memory in patients with schizophrenia. Scores range from 0 to 60, with higher values indicating better performance. Administration takes approximately 35 minutes to complete (including a 20-25 minute delay).

Measure: Changes in Auditory Learning and Memory Score

Time: approximately an hour after dose

Description: During each study visit, participants will complete the Global Neurocognitive Assessment (GNA) before and after administration of drug or placebo to determine the effect of nimodipine on a range of neurocognitive measures in patients with schizophrenia. The GNA contains 10 items with varying score ranges. Higher scores indicate better performance.

Measure: Changes in Global Neurocognitive effect as assessed by the Global Neurocognitive Assessment (GNA)

Time: approximately an hour after dose

Secondary Outcomes

Description: The CACNA1C risk-associated SNP (rs1006737) will be tested using a linear regression (with copy of A alleles) with each cognitive domain score to determine if CACNA1C genetics impact response to nimodipine.

Measure: Effect of CACNA1C genotype on cognitive performance measures

Time: during 2-3 hour study visit

Description: Genetic data will be used more broadly to include testing of the effects of genetic variation including but not limited to schizophrenia, cognition, behavior, and drug metabolism.

Measure: Broader genetic associations with cognitive performance

Time: during 2-3 hour study visit

Purpose: Other

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 rs1006737

Investigators predict that the performance increase induced by nimodipine will be greater in subjects who carry the A allele for the Calcium Voltage-Gated Channel Subunit Alpha1 C (CACNA1C) risk single nucleotide polymorphism (SNP) (rs1006737) in comparison to the response of G carriers.

The CACNA1C risk-associated SNP (rs1006737) will be tested using a linear regression (with copy of A alleles) with each cognitive domain score to determine if CACNA1C genetics impact response to nimodipine.. Broader genetic associations with cognitive performance.



HPO Nodes


HPO:
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