NCT00744328.
| Methods | 8‐week, double‐blind, placebo‐controlled randomised controlled trial |
| Participants | 85 women |
| Interventions | Transdermal oestradiol (50‐200 μg/day) compared with sertraline (25‐200 mg/day) compared with placebo |
| Outcomes | Primary outcome measures include assessing the efficacy of oestradiol as a treatment for postpartum depression, and efficacy in comparison to placebo and sertraline. Secondary outcome measures will include data on infant development using Bayley Scales of Infant Development, mother‐infant serum oestradiol and sertraline levels, quality of mother‐infant interactions. |
| Notes | The study (NCT00744328) is led by Professor Katherine Wisner in the USA, data collection has finished (terminated early due to recruitment issues) and analysis is in progress. Contact information: Emily A. Pinheiro: emily.pinheiro@northwestern.edu |