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Table 1 Summary of OxCaMS trial registration data

From: The Oxford study of Calcium channel Antagonism, Cognition, Mood instability and Sleep (OxCaMS): study protocol for a randomised controlled, experimental medicine study

Data category Information
Registry and ID ISRCTN33631053
Date of registration 8 June 2018
Secondary identifying numbers IRAS 213212
Sources of financial or material support Wellcome Trust, NIHR Oxford Health Biomedical Research Centre, NIHR Oxford cognitive health Clinical Research Facility
Sponsor University of Oxford
Contact for public queries PJH (paul.harrison@psych.ox.ac.uk) or KEAS (kate.saunders@psych.ox.ac.uk)
Contact for scientific queries PJH (paul.harrison@psych.ox.ac.uk) or KEAS (kate.saunders@psych.ox.ac.uk)
Public title OxCaMS
Scientific title Oxford study of Calcium channel Antagonism, Cognition, Mood instability and Sleep
Countries of recruitment UK
Health condition studied Mood instability
Intervention Nicardipine sustained release (30 mg bd) or placebo, for 14 days
Key inclusion criteria Score > 7 on Mood Disorder Questionnaire with evidence of functional impairment. Aged 18–35 years
Key exclusion criteria Current psychotropic medication. Need for urgent psychiatric treatment. Psychiatric disorder or substance misuse which, in the opinion of the investigator, could compromise safety or data quality
Study type Primary purpose: experimental medicine, exploratory study
Allocation: randomised, double-blind, parallel group. 14 day run-in before allocation
Date of first enrolment December 2017
Target sample size 40
Recruitment status Recruiting
Primary outcome Cognitive variability
Key secondary outcomes Mood variability, behavioural variability, BOLD and MEG signals at rest and during task performance, sleep parameters, calcium channels in leukocytes