Grant ID

99-RC-998

Illness

Bipolar Disorder

Primary Drug/Intervention

Valproate and lithium combination

Primary Dosage

N/A

Secondary Drug Intervention

Lithium or valproate monotherapy

Secondary Dosage

N/A

Other Drug/Intervention

N/A

Other Dosage

N/A

Status

Completed

Investigator

Geddes

Sample Size

345

Duration of Study Period for Each Subject

2 year randomised phase

Outcome Measurements

The primary outcome is initiation of new treatment (admission or drug therapy) for new mood symptoms.

Results

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.

Publication

N/A

Link

N/A

PI Name

John Geddes

Degree

MD

Center

Warneford Hospital

Institution

Oxford University

Address

City or Town

Oxford

State or Province

Oxfordshire

Zip or Postal Code

QX10 0RU

Country

United Kingdom

Email Address

john.geddes@psych.ox.ac.uk