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Awarded Trial: 99-RC-998
Valproate and lithium combination
Secondary Drug Intervention
Lithium or valproate monotherapy
Duration of Study Period for Each Subject
2 year randomised phase
The primary outcome is initiation of new treatment (admission or drug therapy) for new mood symptoms.
BALANCE is a large, simple, randomized trial comparing the combination of lithium and valproate semisodium with lithium or valproate semisodium monotherapy in the maintenance treatment of bipolar disorder. The aim is to determine whether combination treatment is more effective than either agent used alone and to provide reliable evidence about the relative effectiveness of the two single agents. Patients who consent to join the trial enter an active run-in phase during which they receive both lithium and valproate semisodium for up to 8 weeks. Those eligible patients for whom there remains uncertainty about maintenance treatment at the end of the run-in phase enter the randomized phase of the trial. Patients are randomized to receive either lithium monotherapy or valproate semisodium monotherapy or a combination therapy with lithium plus valproate semisodium. BALANCE is currently recruiting with from centres in the UK, France, Italy and the USA.
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