Bipolar Affective disorder: Lithium/ANti-Convulsant Evaluatio

niversity of Oxford (UK)0 个研究点目标入组 231 人开始时间: 2005年10月10日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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
•5. Adherence during the run-in phase is judged satisfactory by the investigator

•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

发起方

niversity of Oxford (UK)