The Oxford study of calcium channel antagonism, cognition, mood instability and sleep

Not Applicable

Completed

• Conditions: Mood instability, which is a feature of bipolar disorder and other psychiatric disorders including borderline personality disorder, but can also occur in the absence of any diagnosis; Mental and Behavioural Disorders

• Registration Number: ISRCTN33631053
• Lead Sponsor: niversity of Oxford

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30755265 protocol in :

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-06-08
• Study Completion: 2020-09-30
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 32

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Cognitive variability, measured at varying time points and evaluated using a range of cognitive tasks, comprising: <br>1.1. The N-Back task of working memory (baseline and study endpoint)<br>1.2. The Stop-Signal task (baseline and study endpoint)<br>1.3. The theory of visual attention (TVA) (baseline and study endpoint)<br>1.4. The emotional test battery (ETB) (baseline and study endpoint)<br>1.5. ‘Wheel of fortune’ (daily over the 4-week study period)<br>1.6. Whack-A-T (daily over the 4-week study period)<br>1.7. Fractals (daily over the 4-week study period)