Table 1 Summary of OxCaMS trial registration data
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 |