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We are looking for people with bipolar disorder to take part in research investigating the effect of lithium on mood instability.

OxLith is an 8-week randomised controlled trial comparing the effects of lithium and placebo on mood instability.

About

Most people experience mild mood changes between happiness and sadness often related to the things that happen in their everyday lives.  For some people these changes are severe enough to interfere with day-to-day life and may be a symptom of bipolar disorder.  Bipolar disorder can affect the way people think (e.g. their views and reaction times) and how they behave (e.g. activity level and sleep pattern) as well as their mood.  Focussing research on increasing understanding and improving treatment of mood instability has the potential to greatly reduce the persistent day-to-day effects of bipolar disorder and the frequency of mood episodes.

 Lithium has been shown to be the best available long-term treatment for bipolar disorder and is recommended in treatment guidelines. For example, the NICE (National Institute for Health and Care Excellence) recommend lithium as the first treatment to prevent mood episodes and reduce mood instability.

We do not know exactly how lithium works, or why some people find it very effective whereas others do not. Better understanding of the way in which Lithium affects mood, thinking and behaviour will ensure that those people who can benefit from it can do so safely.

 Who can participate?

Men and women aged 18 or over who have bipolar disorder and are currently experiencing mood instability but not an episode of depression, mania or hypomania. 

What does the study involve?

Take lithium or placebo (you would not know which) for 6 weeks.

Complete a number of daily and weekly assessments of your mood.

Complete brief games daily on an iPad (provided during the trial).

Give blood and saliva samples.

Wear activity and heart monitors.

Have 2, non-invasive, brain scans.

 The study is entirely voluntary and all patients wishing to join the study must complete an informed consent form.

Reimbursement

If you choose to take part in OxLith, as a thank you, we will recompense you for each of the 6 scheduled visits that you attend. Reasonable travel expenses for each visit and a meal allowance for visits that are longer than 3 hours will also be provided.

Date required

Status: Ongoing. OxLith is due to close in April 2018

Taking part

If you are considering seeing your GP because of significant mood disturbance that affects your daily life and the GP thinks it would be appropriate for you to have an assessment for mood instability, then they could opt  to refer you to the  Bipolar Disorder Research Clinic at the Warneford Hospital. If referred, you would receive a psychiatric assessment and, if required, appropriate treatment. You may also be invited to take part in a research study which could be OxLith. You would be given written information about the study and have the opportunity to discuss the research with anyone you choose before deciding whether to take part. You would be under no obligation to take part. 

Contact

Dr Jennifer Rendell. Trial Manager

Email: oxlith@psych.ox.ac.uk

Phone: 01865 902135      

Clinical trial registration details

ISRCTN91624955 http://www.isrctn.com/ISRCTN91624955  

 oxlith information leaflet

 You can download an information leaflet on the study here.

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