FOCUS trial - Fluoxetine Or Control Under Supervision (2019)
The FOCUS trial was a randomised controlled trial that aimed to find out whether fluoxetine given to people for six months after a stroke improves long-term recovery, even if they do not have depression.
3127 participants were recruited from 103 hospitals across the UK. The results did not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.
FOCUS was led by Prof Martin Dennis and Prof Gillian Mead, with collaborators from:
- University of Edinburgh
- National Health Service
- The UK Stroke research network including their user group
- The Scottish Stroke Research Network
- University of Dundee
- University of Leeds
- The George Institute, New South Wales
- University of Western Australia
- Karolinska Institute, Stockholm
Study summary & findings
Results of small trials indicated that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.
1: Dennis M, Forbes J, Graham C, Hackett M, Hankey GJ, House A, Lewis S, Lundström E, Sandercock P, Mead G. Fluoxetine to improve functional outcomes in patients after acute stroke: the FOCUS RCT. Health Technol Assess. 2020 May;24(22):1-94. doi: 10.3310/hta24220.
2: Dennis M, Forbes J, Graham C, Hackett ML, Hankey GJ, House A, Lewis S, Lundström E, Sandercock P, Mead G. Fluoxetine and Fractures After Stroke: Exploratory Analyses From the FOCUS Trial. Stroke. 2019 Nov;50(11):3280-3282. doi: 10.1161/STROKEAHA.119.026639. Epub 2019 Aug 20.
3: FOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Lancet. 2019 Jan 19;393(10168):265-274. doi: 10.1016/S0140-6736(18)32823-X. Epub 2018 Dec 5.
4: Graham C, Lewis S, Forbes J, Mead G, Hackett ML, Hankey GJ, Gommans J, Nguyen HT, Lundström E, Isaksson E, Näsman P, Rudberg AS, Dennis M. The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis. Trials. 2017 Dec 28;18(1):627. doi: 10.1186/s13063-017-2385-6.
5: Mead G, Hackett ML, Lundström E, Murray V, Hankey GJ, Dennis M. The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials. Trials. 2015 Aug 20;16:369. doi: 10.1186/s13063-015-0864-1.
University of Edinburgh and NHS Lothian (UK)
The start-up phase of the FOCUS trial was funded by the UK Stroke Association (TSA 2011101) and the main phase funded by the NIHR Health Technology Assessment Programme (project number 13/04/30).
Functional outcome after acute stroke did not improve with oral fluoxetine 20 mg once daily for 6 months. Fluoxetine reduced the occurrence of depression but increased the risk of bone fractures and hyponatraemia.
EFFECTS Trial Collaboration. Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2020 Aug;19(8):661-669. doi: 10.1016/S1474-4422(20)30219-2.
AFFINITY (Australia, New Zealand & Vietnam)
Oral fluoxetine 20 mg daily for 6 months after acute stroke did not improve functional outcome and increased the risk of falls, bone fractures, and epileptic seizures.
AFFINITY Trial Collaboration. Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2020 Aug;19(8):651-660. doi: 10.1016/S1474-4422(20)30207-6.