Bipolar disorder with current mood instability Mental and Behavioural Disorders Bipolar affective disorder
Conditions
Interventions
Following a 2-week run-in phase, participants will be randomly allocated to take either lithium or placebo for 6 weeks. During the time they are in the study participants will be asked to rate their m
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to give informed consent to participate in the trial 2. Meeting criteria for bipolar disorder 3. Clinical complaint of significant mood instability 4. Clinical uncertainty about the prescription of lithium 5. No clear indication for alternative treatment 6. Pre-treatment blood test results acceptable for initiation of lithium 7. Willing and able to comply with all trial requirements (assessed by a psychiatrist) 8. Willing to allow his or her General Practitioner and, if appropriate, psychiatrist to be notified of participation in the trial
Exclusion criteria
Exclusion criteria: 1. Any contraindication to lithium 2. Currently taking any psychotropic drug that cannot be withdrawn 3. Clinically significant alcohol or substance use 4. Requiring immediate treatment for an acute mood episode such that placebo would be inappropriate 5. Female and pregnant, lactating or currently planning a pregnancy 6. Female of child-bearing potential not willing to use effective contraception 7. Participation in another research trial involving an investigational medicinal product in the past 12 weeks 8. Judged to be at significant immediate risk of suicide/self-harm (Participants with contraindication to one or both brain scans will be excluded from that part of the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in mood instability from weekly self-reports made online or by SMS throughout the trial (https://truecolours.nhs.uk). Depressive symptoms will be reported using the Quick Inventory of Depressive Symptoms (QIDS-SR16) scale and manic symptoms using the ALTMAN scale. Daily self-reports of current mood reported using the (Positive and Negative Affect Scale (PANAS) completed on an iPad | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Performance on cognitive tasks at trial entry and at the final visit and on brief tasks completed daily on an iPad throughout the trial 2. Data on the way information is processed in the brain using magnetic resonance imaging (MRI) and magnetoencephalography (MEG) scans during week 4 3. Actigraphy data collected on small devices worn on the wrist or attached to clothing continuously throughout the trial to provide information on activity levels and sleep patterns 4. Changes related to circadian rhythms measured from cheek swabs and saliva samples which participants will collect at intervals over two 32-hour periods, one prior to entry to the randomised phase and the second during week 4 5. Changes in blood levels of biomarkers for related to adverse effects of lithium from blood samples taken at trial entry and at the final trial visit. Two additional blood samples will be taken in the first 2 weeks following randomisation to check lithium levels | — |
Countries
England, United Kingdom
Contacts
Public ContactKate Saunders
Outcome results
None listed