Trial design
The trial has 2 phases:
1. Active run-in phase
All participants will enter a 7 to 14 day run-in phase during which they will be prescribed quetiapine. The run-in phase is designed to:
- provide immediate treatment for bipolar depression
- ensure that people who enter the randomised phase can tolerate quetiapine and have depressive symptoms which are persistent and severe enough for additional treatment (i.e. lamotrigine and folic acid) to be considered.
2. Randomised phase
After 7 – 14 days in the run-in phase, people who can tolerate quetiapine but are still moderately/severely depressed will enter the one year randomised phase. All participants will continue treatment with quetiapine and, in addition to this, will be randomly allocated to take:
- lamotrigine or matching placebo
and - folic acid# or matching placebo.
# People who want to participate in the trial but either require treatment with folic acid or should not take folic acid can be randomised to lamotrigine or placebo and continue to take/not take folic acid.
The randomisation process will therefore allocate participants to one of four treatment groups*:
- Group A will be given quetiapine plus lamotrigine plus folic acid
- Group B will be given quetiapine plus lamotrigine plus folic acid placebo
- Group C will be given quetiapine plus lamotrigine placebo plus folic acid
- Group D will be given quetiapine plus lamotrigine placebo plus folic acid placebo
* All participants will therefore be taking at least one active medicine.
Page last edited: 22 October 2008
