Cognitive Effects of Nimodipine in Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Cognitive Effects of Nimodipine in Patients With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671525
• Other study ID #: IRB00168634
• Status: Completed
• Phase: Early Phase 1
• Start date: October 5, 2018
• Est. completion date: May 12, 2023

Study information

• Verified date: May 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The main cognitive task of interest in this study is the N-back task because of the observed attenuation of prefrontal and parietal cortical activity after nimodipine administration in healthy subjects. Investigators hypothesize that acute nimodipine administration will improve cortical activation, which will lead to improved cognitive performance. The current study will provide insight whether nimodipine or another calcium channel blocker could be used as a treatment approach to alleviate cognitive deficits in patients with schizophrenia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• This study will recruit patients with schizophrenia and/or schizoaffective disorder

Exclusion Criteria:

• past or current neurological disorder (including stroke, brain tumor, epilepsy, Alzheimer's, Parkinson's or Huntington's disease)

• uncontrolled medical disorder

• current or past hypotension

• head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma

• positive pregnancy test, or currently breast feeding

• having an adverse reaction to nimodipine, or other calcium channel blocker

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia

Intervention

Drug:
• Nimodipine
Subject will receive two 30mg capsules of nimodipine during study visit.
• Placebo oral capsule
Two coconut oil capsules that mimic the size and color of the nimodipine capsules

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain activity as assessed by BOLD fMRI	participants will complete an MRI scan to link brain activity with cognitive performance. Measures will be recorded in Arbitrary units.	between 30 min and 1 hour after dose
Primary	Changes in Visual Learning and Memory Score	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)	approximately an hour after dose
Primary	Changes in Auditory Learning and Memory Score	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).	approximately an hour after dose
Primary	Changes in Global Neurocognitive effect as assessed by the Global Neurocognitive Assessment (GNA)	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.	approximately an hour after dose
Secondary	Effect of CACNA1C genotype on cognitive performance measures	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.	during 2-3 hour study visit
Secondary	Broader genetic associations with cognitive performance	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.	during 2-3 hour study visit