Cognitive Effects of Nimodipine in Patients With Schizophrenia

NCT ID: NCT03671525

Last Updated: 2023-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-05

Study Completion Date

2023-05-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Schizophrenia Schizo Affective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nimodipine

One 60mg capsule of nimodipine on first or second study visit

Group Type EXPERIMENTAL

Nimodipine

Intervention Type DRUG

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

Placebo

One placebo capsule on first or second study visit

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

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

Interventions

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Nimodipine

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

Intervention Type DRUG

Placebo oral capsule

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

Intervention Type DRUG

Other Intervention Names

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Nymalize

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin Bigos, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00168634

Identifier Type: -

Identifier Source: org_study_id

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