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Completed

NCT Number: NCT03671525

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.

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Key information

Conditions

Schizophrenia Mental Disorders Psychotic Disorders Schizo Affective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nimodipine

Drug

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

Other names: Nymalize

Placebo oral capsule

Drug

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

Primary outcomes

  1. Brain activity as assessed by BOLD fMRI

    Time frame: between 30 min and 1 hour after dose

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

  2. Changes in Visual Learning and Memory Score

    Time frame: approximately an hour after dose

    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)

  3. Changes in Auditory Learning and Memory Score

    Time frame: approximately an hour after dose

    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).

  4. Changes in Global Neurocognitive effect as assessed by the Global Neurocognitive Assessment (GNA)

    Time frame: approximately an hour after dose

    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.

Secondary outcomes

  1. Effect of CACNA1C genotype on cognitive performance measures

    Time frame: during 2-3 hour study visit

    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.

  2. Broader genetic associations with cognitive performance

    Time frame: during 2-3 hour study visit

    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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2018
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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