ISRCTN33631053Completed未知
The Oxford study of calcium channel antagonism, cognition, mood instability and sleep
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- niversity of Oxford
- Enrollment
- 32
Study Overview
Brief Summary
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30755265 protocol in :
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Healthy volunteers with score of =7 on the Mood Disorder Questionnaire (MDQ) with evidence of associated functional impairment:
- •1. Willing and able to given informed consent to participate in the study
- •2. Male or female
- •3. Aged 18 – 35
- •4. Significant mood instability (defined as a score of =7 on the Mood Disorder Questionnaire) causing at least mild dysfunction
- •5. No indication that urgent psychiatric treatment is required
- •6. Pre-treatment tests including renal, cardiac and liver function acceptable for the initiation of treatment with nicardipine
- •7. Willing and able to comply with the study requirements
- •8. Willing to allow his/her General Practitioner, if appropriate, to be notified of his/her participation in the study
Exclusion Criteria
- •1. Contraindication(s) to nicardipine (as documented in the Summary of Product Characteristics for Cardene SR)
- •2. History of or current axis I mental disorder if, in the opinion of the investigator, it will compromise safety or affect data quality
- •3. Regular psychotropic drug use within the last 12 weeks. Recent ‘as required’ use of psychotropic medication may be permitted at the investigators' discretion, if it will not compromise safety or affect data quality
- •4. Currently taking any other medication or herbal extracts that would affect study results or safety (e.g. St. John’s Wort)
- •5. Participant judged to be at significant immediate risk of suicide/self-harm
- •6. Clinically significant alcohol use or substance misuse
- •7. Requiring urgent treatment for an acute mood episode
- •8. Female and pregnant, lactating or planning a pregnancy during the course of the study
- •9. Female of child-bearing potential not willing to use effective contraception
- •10. Participation in a research study involving an investigational medicinal product in the previous 12 weeks
- •11. Individuals who are intolerant of or unwilling to take lactose or gelatine
- •12. Participants who have a pacemaker, non-MR-compatible metal implant, or any other contraindication for MR or MEG brain scanning will be excluded from the corresponding brain scanning element(s) of the study
- •13. Individuals who are not willing to consume gelatine (due to drug and placebo capsules being made of gelatine)
Investigators
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