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
Conditions
Interventions
The intervention is nicardipine or placebo. The design is as follows. There is a 14-day run-in phase (when participants undergo functional brain imaging and complete repeated assessments of mood, cogn
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive variability, measured at varying time points and evaluated using a range of cognitive tasks, comprising: 1.1. The N-Back task of working memory (baseline and study endpoint) 1.2. The Stop-Signal task (baseline and study endpoint) 1.3. The theory of visual attention (TVA) (baseline and study endpoint) 1.4. The emotional test battery (ETB) (baseline and study endpoint) 1.5. ‘Wheel of fortune’ (daily over the 4-week study period) 1.6. Whack-A-T (daily over the 4-week study period) 1.7. Fractals (daily over the 4-week study period) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood oxygen level dependent signal during rest and during cognitive testing (fMRI); induced and evoked field activity (MEG); measured pre- and post- randomisation to nicardipine/placebo, on study days 14 and 28 respectively 2. Activity monitored by Geneactiv watch (daily over the 4-week study period) 2.1. Actigraphy data from a maximum of two wearable units, allowing analysis of indices of: 2.1.1. Frequency and amplitude of movements during daytime activity 2.1.2. Categorisation of activity types 2.1.3. Duration, timing, and quality of sleep 2.2. Sleep quality indicator questionnaire, measured at baseline and post-randomisation to nicardipine/placebo 3. Leucocyte calcium channel expression and calcium signalling, measured using qPCR quantification of calcium channel subunit transcripts and Fura dye imaging of calcium fluxes, at baseline and study endpoint 4. Heart rate (R-R interval) variability, measured by ePatch fitted at baseline visit for 72 hours, and again three days after commencing nicardipine/placebo for a further 72 hours 5. Mood instability as defined using root mean square of the successive differences (RMSSD), measured by twice daily PANAS questionnaire over the 4-week study period | — |
Countries
England, United Kingdom
Contacts
Public ContactPaul Harrison
Outcome results
None listed