COMBINER

Bipolar disorder (BD) is a severe mood disorder characterised by episodes of hypomania / mania and depression.

Maintenance treatment is critical to reducing the number of mood episodes experienced over a person's lifetime. Lithium is recommended as the first line maintenance treatment, but antipsychotics are often prescribed instead of or in addition to lithium. Combination treatment could be more effective, but tolerability is more of an issue. Currently there is a lack of good quality evidence to help clinicians and patients make choices about whether lithium, an antipsychotic, or a combination of both is best in maintenance treatment.

Primary objective:

To evaluate whether a combination of lithium and quetiapine increases time to next mood episode (a measure of relapse/symptoms) over 24 months in comparison to lithium or quetiapine in the maintenance treatment of BD.

Secondary objectives:

To evaluate in the maintenance treatment of BD:

• the effectiveness of lithium vs quetiapine on time to new mood episode over 24 months.
• the effectiveness of lithium plus quetiapine vs lithium vs quetiapine on health related quality of life (QoL), functioning, and other important outcomes at 12 and 24 months.
• the cost-effectiveness of lithium plus quetiapine vs lithium vs quetiapine