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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
Name: Placebo oral capsule
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 doseDescription: 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 doseDescription: 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 doseDescription: 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 doseSecondary 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 visitDescription: 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 visitPurpose: 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.