Clinical trial NCT03671525: Cognitive Effects of Nimodipine in Patients With Schizophrenia
Official title: Cognitive Effects of Nimodipine in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Schizo Affective Disorder
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Brain activity as assessed by BOLD fMRI
timeFrame: between 30 min and 1 hour after dose
measure: Changes in Visual Learning and Memory Score
timeFrame: approximately an hour after dose
measure: Changes in Auditory Learning and Memory Score
timeFrame: approximately an hour after dose
measure: Changes in Global Neurocognitive effect as assessed by the Global Neurocognitive Assessment (GNA)
timeFrame: approximately an hour after dose
Secondary outcomes:
measure: Effect of CACNA1C genotype on cognitive performance measures
timeFrame: during 2-3 hour study visit
measure: Broader genetic associations with cognitive performance
timeFrame: during 2-3 hour study visit
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kristin Bigos, PhD
role: PRINCIPAL_INVESTIGATOR
References: