Andre C Vogel1, Kigocha Okeng'o2, Faraja Chiwanga3, Seif Sharif Ismail2, Deus Buma4, Lindsay Pothier5, Farrah J Mateen6. 1. Massachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA. Electronic address: avogel@partners.org. 2. Muhimbili National Hospital, Neurology Unit, Dar es Salaam, Tanzania. 3. Muhimbili National Hospital, Department of Pharmacy, Dar es Salaam, Tanzania. Electronic address: faraja.chiwanga@mnh.or.tz. 4. Muhimbili National Hospital, Department of Pharmacy, Dar es Salaam, Tanzania. Electronic address: deus.buma@mnh.or.tz. 5. Massachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA. Electronic address: lmpothier@partners.org. 6. Massachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA; Harvard Medical School, 25 Shattuck St, Boston, MA 02115, USA. Electronic address: fmateen@partners.org.
Abstract
BACKGROUND: SSA has a high stroke incidence and post-stroke morbidity. An inexpensive pharmacological treatment for stroke recovery would be beneficial to patients in the region. Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA. AIM: To determine if fluoxetine 20 mg by mouth daily, given within 14 days of acute ischemic stroke, and taken for 90 days, is well-tolerated and safe with adequate adherence to justify a future randomized, controlled trial of fluoxetine in the United Republic of Tanzania. METHODS: Open-label, phase II clinical trial enrolling up to 120 patients. Participants will be recruited from the Muhimbili National Hospital in Dar es Salaam, Tanzania, and followed for 90 days. The primary outcomes are: 1) safety, including serum sodium and hepatic enzyme levels; and 2) tolerability, as measured through study case report forms. The secondary outcomes are: 1) change in motor strength, as measured through the Fugl-Meyer Motor Scale; 2) adherence, as measured with electronic pill bottles; and 3) participant depressive symptom burden measured via standard questionnaires. CONCLUSIONS: Expanding the evidence base for fluoxetine for Sub-Saharan African stroke survivors requires testing of its safety, tolerability, and adherence. Compared to prior studies in France and the United Kingdom, the patient characteristics, health infrastructure, and usual care for stroke recovery differ substantially in Tanzania. If fluoxetine reveals favorable endpoints, scale up of its use post-stroke is possible.
BACKGROUND: SSA has a high stroke incidence and post-stroke morbidity. An inexpensive pharmacological treatment for stroke recovery would be beneficial to patients in the region. Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA. AIM: To determine if fluoxetine 20 mg by mouth daily, given within 14 days of acute ischemic stroke, and taken for 90 days, is well-tolerated and safe with adequate adherence to justify a future randomized, controlled trial of fluoxetine in the United Republic of Tanzania. METHODS: Open-label, phase II clinical trial enrolling up to 120 patients. Participants will be recruited from the Muhimbili National Hospital in Dar es Salaam, Tanzania, and followed for 90 days. The primary outcomes are: 1) safety, including serum sodium and hepatic enzyme levels; and 2) tolerability, as measured through study case report forms. The secondary outcomes are: 1) change in motor strength, as measured through the Fugl-Meyer Motor Scale; 2) adherence, as measured with electronic pill bottles; and 3) participantdepressive symptom burden measured via standard questionnaires. CONCLUSIONS: Expanding the evidence base for fluoxetine for Sub-Saharan African stroke survivors requires testing of its safety, tolerability, and adherence. Compared to prior studies in France and the United Kingdom, the patient characteristics, health infrastructure, and usual care for stroke recovery differ substantially in Tanzania. If fluoxetine reveals favorable endpoints, scale up of its use post-stroke is possible.
Authors: Kwan L Ng; Ellen M Gibson; Robert Hubbard; Juemin Yang; Brian Caffo; Richard J O'Brien; John W Krakauer; Steven R Zeiler Journal: Stroke Date: 2015-08-20 Impact factor: 7.914
Authors: Robert W Regenhardt; Maijo R Biseko; Agness F Shayo; Theoflo N Mmbando; Sara J Grundy; Ai Xu; Altaf Saadi; Leah Wibecan; G Abbas Kharal; Robert Parker; Joshua P Klein; Farrah J Mateen; Kigocha Okeng'o Journal: Int J Qual Health Care Date: 2019-06-01 Impact factor: 2.038
Authors: Camila B Pinto; Faddi G Saleh Velez; Fernanda Lopes; Polyana V de Toledo Piza; Laura Dipietro; Qing M Wang; Nicole L Mazwi; Erica C Camargo; Randie Black-Schaffer; Felipe Fregni Journal: Front Neurosci Date: 2017-11-16 Impact factor: 4.677
Authors: Farrah J Mateen; Emmanuel Massawe; Notburga A Mworia; Seif Ismail; Dylan R Rice; Andre C Vogel; Boniface Kapina; Novath Mukyanuzi; Deus C Buma; Jef Gluckstein; Michael Wasserman; Susan E Fasoli; Faraja Chiwanga; Kigocha Okeng'o Journal: Am J Trop Med Hyg Date: 2021-12-06 Impact factor: 3.707
Authors: Rajesh N Kalaria; Mayowa O Owolabi; Rufus O Akinyemi; Bruce Ovbiagele; Olaleye A Adeniji; Fred S Sarfo; Foad Abd-Allah; Thierry Adoukonou; Okechukwu S Ogah; Pamela Naidoo; Albertino Damasceno; Richard W Walker; Adesola Ogunniyi Journal: Nat Rev Neurol Date: 2021-09-15 Impact factor: 42.937