Trial of lithium & valproate in bipolar disorder

Most people experience mild mood changes between happiness and sadness. These are often caused by the things that happen to them in everyday life. For some, however, these mood changes can be severe enough to interfere with day-to-day functioning. These people suffer from bipolar disorder (also known as manic depression). Sustained elevated or irritable mood is called a manic episode and sustained low mood, loss of energy and sadness is called a depressive episode. About 1 person in 100 suffers from bipolar disorder which affects their lives and the lives of those who live and work with them. Many will face the disruption of repeated admissions to hospital.

Many people who have had recurrent episodes of bipolar disorder need regular long-term medicine to pr. event manic and depressive relapses and to provide improved day-to-day stability of mood. Several medicines are available but it is unclear which is the most effective, or if they work best on their own or in combination. The best way to compare treatments for any illness is to conduct a clinical trial but, to date, very little
research has been done comparing treatments for prevention of manic and depressive episodes in bipolar disorder

BALANCE is a large scale randomised clinical trial comparing the effectiveness of three frequently used treatments for relapse prevention:

lithium alone
valproate semisodium alone
lithium and valproate semisodium combination

BALANCE has been designed to produce helpful and reliable results – and to cause as little inconvenience as possible to participants and their doctors.

Completion of the trial

At the end of the trial, participants will discuss with their psychiatrist whether to continue with the treatment that they took during the trial or to change to a different treatment.

Effective treatment An effective long-term treatment is one which reduces the risk of manic or depressive episodes without unpleasant side-effects or long-term lowering of mood.

In the BALANCE Trial, the main measures of effectiveness are:

reduction in number of peopleadmitted to hospital
reduction in use of additional medication for mood symptoms

The trial will also measure:

side-effects
long-term effects on mood
quality of life
deliberate self harm

Will participants get the best treatment?
People should only take part in the trial if both they and their psychiatrist are uncertain about which of the trial treatments would be best for them. This uncertainty means that random allocation of treatment is just as likely to select the best treatment for them as any other way of selecting treatment.

The trial is being funded by a US mental health charity, the Stanley Medical Research Institute.

The University of Oxford is the sponsor of the trial.

Priadel and Depakote have been donated by Sanofi-Aventis. The trial has been designed independently
of the manufacturers of the drugs.

The trial has the support of the Mental Health Research Network.

For more information:

         The BALANCE Of?ce

Department Of Psychiatry
Warneford Hospital
Oxford OX3 7JX
Tel: 01865 – 223731 Fax: 01865 – 223900
email: balance@psych.ox.ac.uk
url: www.psychiatry.ox.ac.uk/balance