Bipolar Affective disorder: Lithium/ANti-Convulsant Evaluatio

Completed

• Conditions: Bipolar disorder; Mental and Behavioural Disorders

• Registration Number: ISRCTN55261332
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-10
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified