Cognitive Effects of Nimodipine in Patients With Schizophrenia

Johns Hopkins University

Status and phase: Completed; Early Phase 1

Conditions: Schizophrenia; Schizo Affective Disorder

Treatments: Drug: Placebo oral capsule; Drug: Nimodipine

Study type: Interventional

Funder types: Other

Identifiers

NCT03671525

IRB00168634

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

Nimodipine

Experimental group

Description:

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

Treatment:

Drug: Nimodipine

Placebo

Placebo Comparator group

Description:

One placebo capsule on first or second study visit

Treatment:

Drug: Placebo oral capsule