The Balance Trial is an important, large scale, multicenter study that may be of interest to ISBD members. The ISBD will include the study information in our upcoming Spring ISBD Global Newsletter. Study Sites are now available.

The BALANCE Trial

Study Description
Primary Outcome Measures
Study Design
Geographical Coverage
Study Sites
For More Information

 

 

 

 

The BALANCE Trial: There is general recognition that we need many more trials to build a reliable evidence base to inform clinical practice in the area of bipolar disorders. BALANCE is a large scale randomized clinical trial of maintenance treatment for bipolar disorder. The trial compares combination therapy with lithium plus valproate with lithium/valproate monotherapy for prevention of manic and depressive relapses. BALANCE needs to be a large trial because it is comparing active treatments and focusing on important outcomes such as the need for treatment for new mood symptoms. All participants are initially treated with combination therapy for 4-8 weeks (see Fig1) to ensure that they can tolerate both drugs and to establish maintenance doses. Where appropriate, participants are then randomized to one of the three treatment regimens for up to 2 years. (For participants allocated monotherapy, the discontinued drug is withdrawn gradually over a 4 week period).

Figure 1 Design of the Balance Trial

 

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The primary outcome measure for the trial is the initiation of new treatment (admission to hospital or drug treatment) for an emerging mood episode. Health-related quality of life is measured using the EuroQol (EQ-5D) and participants are asked to complete a questionnaire on adverse effects. Other secondary measures include incidence of acts of deliberate self-harm and clinician rating of health status on the Global Assessment of Functioning Scale.

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BALANCE has been designed to be as simple as possible - this should help us achieve the large scale participation that we need to get the required sample size. The trial procedures were extensively tested during pilot and start-up phases to make sure they were quick and easy in the real world. The trial procedures integrate well with routine clinical care and involve minimal inconvenience to both participants and clinicians. No additional clinic appointments are required for follow up and no extra clinical investigations are involved.

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BALANCE will continue to recruit until the end of December 2006. The trial has a site in the USA (Boston), Italy (Verona) and a number of sites in France and the UK. The trial is being co-ordinated in Oxford where the trial centre develops and maintains a network of research-oriented psychiatrists who will initiate and participate in a range of trials of treatment for bipolar disorder. Future trials are being planned including the BALANCE 2 trial comparing SSRIs, lamotrigine and quetiapine for bipolar depression. These will involve wider collaboration, particularly with psychiatrists from Europe. BALANCE is funded by the Stanley Medical Research Institute and Sanofi Aventis have donated the trial drugs for the UK and provide support for the French sites. For more information contact Professor John Geddes, Principal Investigator/Clinical Coordinator or Jennifer Rendell, Trial Manager via email at balance@psych.ox.ac.uk or at the BALANCE Office: University of Oxford Department of Psychiatry Warneford Hospital, Oxford OX3 7JX or visit our website http://www.psychiatry.ox.ac.uk/balance/ .

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Current BALANCE Sites

United Kingdom Sites
Avon and Wiltshire Mental Health Partnership NHS Trust

Berkshire Healthcare NHS Trust Bolton

Salford and Trafford Mental Health Partnership NHS Trust

Cambridgeshire and Peterborough Mental Health Partnership NHS Trust

Cardiff and Vale NHS Trust

Cheshire and Wirral Partnership NHS Trust

Central and North West London Mental Health NHS Trust

Devon Partnership NHS Trust

East London and the City Mental Health NHS Trust

Hertfordshire Partnership NHS Trust

Leicestershire Partnership NHS Trust

Manchester Mental Health and Social Care NHS Trust

Mersey Care NHS Trust

Newcastle, North Tyneside and Northumberland Mental Health NHS Trust

Nottinghamshire Healthcare NHS Trust

Northamptonshire Healthcare NHS Trust

Oxfordshire Mental Healthcare NHS Trust

Royal Cornwall Hospitals NHS Trust

South London and Maudsley NHS Trust

South Warwickshire Combined Care NHS Trust

Surrey Hampshire Borders NHS Trust

West Hampshire NHS Trust

Worcestershire Mental Health Partnership NHS Trust

USA Sites
Massachusetts General Hospital

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For more information contact Professor John Geddes, Principal Investigator/Clinical Coordinator or Jennifer Rendell Trial Manager via email at balance@psych.ox.ac.uk

or at the BALANCE Office:
University of Oxford
Department of Psychiatry
Warneford Hospital, Oxford OX3 7JX

or visit our website http://www.psychiatry.ox.ac.uk/balance/ .

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