Outcomes
Primary measure of efficacy
The main assessment of efficacy will be the proportion of people in each group whose depressive symptoms have remitted after 12 weeks in the randomised phase. Depressive symptoms will be measured using a brief questionnaire which will be completed by participants. The effects of lamotrigine will be assessed by comparing the proportion of participants in Groups A and B who symptoms remit with the proportion of participants in Groups C and D. Similarly the effects of folic acid will be assessed by comparing Groups A and C with Groups B and D.
Secondary outcome measures include
- the proportion of time in the year following entry to the randomised phase when participants were free from depressive and manic symptoms
- the safety and tolerability of treatments
- the effects of treatments on quality of life
- the need for additional health and social care resources
Page last edited: 22 October 2008
