Van Heeringen 1996.
Study characteristics | |
Methods | 6‐week, randomised, double‐blind, placebo‐controlled, single‐centre study |
Participants | Women aged > 18 years with breast cancer at stage I or II, without metastases, not qualifying for primary surgical treatment, treated with radiotherapy, and depression, diagnosed according to DSM‐III criteria, and 21‐item HAM‐D score ≥ 16 |
Interventions | Mianserin: fixed dose at 30 mg/day for first week and 60 mg/day thereafter (28 participants) Placebo (27 participants) |
Outcomes | Efficacy and safety; depression assessed using 21‐item HAM‐D after 2, 4 and 6 weeks; tolerability assessed using the Record of Symptoms Emerging and clinical evaluation of vital signs and laboratory measurements |
Notes |