Bipolar Affective disorder: Lithium/ANti-Convulsant Evaluatio

niversity of Oxford (UK)0 sites231 target enrollmentOctober 10, 2005

Overview

No summary available.

Registry

who.int

Start Date

October 10, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Oxford (UK)

•For entry to the run\-in phase:
•1\. Previous episode of mania (clinical diagnosis, guided by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition \[DSM\-IV] criteria) that merited treatment (whether or not treatment was provided)
•2\. Agreement between investigator and patient to commence/continue treatment to
•prevent relapse
•3\. It is considered clinically reasonable to try combination treatment with lithium and valproate semisodium
•For randomisation:
•1\. Uncertainty about which trial treatment would be best for the participant
•2\. Lithium plasma level 0\.4 to 1\.0 mmol/litre on stable dose of lithium
•3\. If valproate semisodium dose is less than 750 mg a day, the participant must have a valproic acid serum level of at least 50 µg/ml
•4\. The participant can tolerate the combination of lithium and valproate semisodium

•1\. Maintenance treatment is considered unnecessary
•2\. A particular maintenance treatment is definitely indicated or contraindicated, or the
•patient is unwilling to take one or other of the study treatments
•3\. A medical disorder or condition coexists which contraindicates either of the investigational drugs, e.g., pregnancy
•4\. The patient is not normally resident in the UK or is of no fixed abode