CEQUEL-FA: Comparative evaluation of quetiapine plus lamotrigine vs quetiapine monotherapy, and folic acid vs placebo

People with bipolar depression have considerable unmet treatment needs whcih means that they often suffer from continuing symptoms and disability. For the first time, promising drug treatments are now emerging, but we need to know how they can best ben used to help people. We will do a randomised clinical trial investigating the combination of quetiapine and lamotrigine which will help clinicians and patients to choose the best treatment for depressive symptoms in bipolar disorder. We will also investigate the possibility that folic acid - a naturally occurring vitamin - will improve symptoms

CEQUEL-FA is a randomised controlled trial investigating the efficacy of combination lamotrigine plus quetiapiane in people with bipolar depression. The trial is a 2x2 factorial design with patients additionally being randomised to folic acid or placebo. The trial outcomes are remission from depressive symptoms at 12 weeks and maintenance of improvement by 12 months. A number of secondary analyses will be conducted which should yield valuable knowledge about the neurobiology of folic acid in mood disorders.

The results of CEQUEL-FA will guide therapy for people with bipolar disorder for many years to come and will inform the development of future clinical practice guidelines