Fluoxetine for motor recovery after acute intracerebral hemorrhage (FMRICH): Study protocol for a randomized, double-blind, placebo-controlled, multicenter trial

Trials

Volumn 14, Issue 1, 2013, Pages

  Marquez Romero, Juan Manuel ^a,b   Arauz, Antonio ^b   Ruiz Sandoval, José Luis ^c   Cruz Estrada, Erick de la ^d   Huerta Franco, Maria Raquel ^e   Aguayo Leytte, Gerónimo ^f   Ruiz Franco, Angélica ^b   Silos, Humberto ^b  

^a Ciudad Universitaria   (Mexico)

^b NATIONAL INSTITUTE OF NEUROLOGY AND NEUROSURGERY   (Mexico)

^c UNIVERSITY OF GUADALAJARA   (Mexico)

^d Hospital De Alta Especialidad Dr Juan Graham Casasus   (Mexico)

^e UNIVERSITY OF GUANAJUATO   (Mexico)

^f Hospital Miguel Hidalgo   (Mexico)

Author keywords

Fluoxetine; Intracerebral hemorrhage; Motor recovery; Randomized controlled trial; Stroke

Indexed keywords

FLUOXETINE; PLACEBO;

ACUTE INTRACEREBRAL HEMORRHAGE; ADULT; AGE DISTRIBUTION; ARTICLE; BARTHEL INDEX; BRAIN HEMORRHAGE; CLINICAL ASSESSMENT TOOL; CLINICAL PROTOCOL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DEVELOPED COUNTRY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FUGL MEYER MOTOR SCALE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEXICO; MOTOR PERFORMANCE; MULTICENTER STUDY; NATIONAL INSTITUTES OF HEALTH STROKE SCALE; PATIENT ASSESSMENT; PATIENT COMPLIANCE; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; RANKIN SCALE; SCREENING TEST; SEX DIFFERENCE; TREATMENT OUTCOME;

CEREBRAL HEMORRHAGE; CLINICAL PROTOCOLS; DISABILITY EVALUATION; DOUBLE-BLIND METHOD; FEMALE; FLUOXETINE; HUMANS; MALE; MEXICO; MOTOR ACTIVITY; RECOVERY OF FUNCTION; RESEARCH DESIGN; SEROTONIN UPTAKE INHIBITORS; STROKE; TIME FACTORS; TREATMENT OUTCOME;

EID: 84875015013     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/1745-6215-14-77     Document Type: Article

References (30)

1. Morgenstern LB, Hemphill JC, Anderson C, Becker K, Broderick JP, Connolly ES, Greenberg SM, Huang JN, MacDonald RL, Messe SR, Mitchell PH, Selim M, Tamargo RJ, American Heart Association Stroke Council and Council on Cardiovascular Nursing Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke 2010, 41:2108-2129. 10.1161/STR.0b013e3181ec611b, 20651276, American Heart Association Stroke Council and Council on Cardiovascular Nursing.
2. Qureshi AI, Tuhrim S, Broderick JP, Batjer HH, Hondo H, Hanley DF. Spontaneous intracerebral hemorrhage. N Engl J Med 2001, 344:1450-1460. 10.1056/NEJM200105103441907, 11346811.
3. Saposnik G, Del Brutto OH. Stroke in South America: a systematic review of incidence, prevalence, and stroke subtypes. Stroke 2003, 34:2103-2107. 10.1161/01.STR.0000088063.74250.DB, 12907823.
4. Zahuranec DB, Brown DL, Lisabeth LD, Gonzales NR, Longwell PJ, Eden SV, Smith MA, Garcia NM, Morgenstern LB. Differences in intracerebral hemorrhage between Mexican Americans and non-Hispanic whites. Neurology 2006, 66:30-34. 10.1212/01.wnl.0000191402.41914.d2, 16401841.
5. Romano JG, Arauz A, Koch S, Dong C, Marquez JM, Artigas C, Merlos M, Hernandez B, Roa LF, Rundek T, Sacco RL. Disparities in Stroke Type and Vascular Risk Factors Between 2 Hispanic Populations in Miami and Mexico City. J Stroke Cerebrovasc Dis 2012, Epub ahead of print.
6. Steiner T, Petersson J, Al-Shahi Salman R, Christensen H, Cordonnier C, Csiba L, Harnof S, Krieger D, Mendelow D, Molina C, Montaner J, Overgaard K, Roine RO, Schmutzhard E, Tatlisumak T, Toni D, Stapf C, European Research Network on Intracerebral Haemorrhage European research priorities for intracerebral haemorrhage. Cerebrovasc Dis 2011, 32:409-419. 10.1159/000330653, 21986448, European Research Network on Intracerebral Haemorrhage.
7. Staykov D, Huttner HB, Kohrmann M, Bardutzky J, Schellinger PD. Novel approaches to the treatment of intracerebral haemorrhage. Int J Stroke 2010, 5:457-465. 10.1111/j.1747-4949.2010.00487.x, 21050402.
8. Dam M, Tonin P, De Boni A, Pizzolato G, Casson S, Ermani M, Freo U, Piron L, Battistin L. Effects of fluoxetine and maprotiline on functional recovery in poststroke hemiplegic patients undergoing rehabilitation therapy. Stroke 1996, 27:1211-1214. 10.1161/01.STR.27.7.1211, 8685930.
9. Pariente J, Loubinoux I, Carel C, Albucher JF, Leger A, Manelfe C, Rascol O, Chollet F. Fluoxetine modulates motor performance and cerebral activation of patients recovering from stroke. Ann Neurol 2001, 50:718-729. 10.1002/ana.1257, 11761469.
10. Zittel S, Weiller C, Liepert J. Citalopram improves dexterity in chronic stroke patients. Neurorehabil Neural Repair 2008, 22:311-314. 10.1177/1545968307312173, 18219053.
11. Acler M, Robol E, Fiaschi A, Manganotti P. A double blind placebo RCT to investigate the effects of serotonergic modulation on brain excitability and motor recovery in stroke patients. J Neurol 2009, 256:1152-1158. 10.1007/s00415-009-5093-7, 19306038.
12. Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol 2011, 10:123-130. 10.1016/S1474-4422(10)70314-8, 21216670.
13. Mikami K, Jorge RE, Adams HP, Davis PH, Leira EC, Jang M, Robinson RG. Effect of antidepressants on the course of disability following stroke. Am J Geriatr Psychiatr 2011, 19:1007-1015.
14. Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med 1975, 7:13-31.
15. Mahoney FI, Barthel DW. Functional Evaluation: The Barthel Index. Md State Med J 1965, 14:61-65.
16. Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67:361-370. 10.1111/j.1600-0447.1983.tb09716.x, 6880820.
17. López-Roig S, Terol MC, Pastor-Mira MA, Neipp MC, Massutí B, Rodríguez-Marín J. Anxiety and Depression. The HAD scale validation in cancer patients. Revista de Psicología de la Salud 2000, 12:127-155.
18. Aben I, Verhey F, Lousberg R, Lodder J, Honig A. Validity of the beck depression inventory, hospital anxiety and depression scale, SCL-90, and hamilton depression rating scale as screening instruments for depression in stroke patients. Psychosomatics 2002, 43:386-393. 10.1176/appi.psy.43.5.386, 12297607.
19. Kelly PJ, Furie KL, Shafqat S, Rallis N, Chang Y, Stein J. Functional recovery following rehabilitation after hemorrhagic and ischemic stroke. Arch Phys Med Rehabil 2003, 84:968-972. 10.1016/S0003-9993(03)00040-6, 12881818.
20. Schepers VP, Ketelaar M, Visser-Meily AJ, de Groot V, Twisk JW, Lindeman E. Functional recovery differs between ischaemic and haemorrhagic stroke patients. J Rehabil Med 2008, 40:487-489. 10.2340/16501977-0198, 18509566.
21. Katrak PH, Black D, Peeva V. Do stroke patients with intracerebral hemorrhage have a better functional outcome than patients with cerebral infarction?. PM R 2009, 1:427-433. 10.1016/j.pmrj.2009.03.002, 19627929.
22. Nannetti L, Paci M, Pasquini J, Lombardi B, Taiti PG. Motor and functional recovery in patients with post-stroke depression. Disabil Rehabil 2005, 27:170-175. 10.1080/09638280400009378, 15824047.
23. Rost NS, Smith EE, Chang Y, Snider RW, Chanderraj R, Schwab K, FitzMaurice E, Wendell L, Goldstein JN, Greenberg SM, Rosand J. Prediction of functional outcome in patients with primary intracerebral hemorrhage: the FUNC score. Stroke 2008, 39:2304-2309. 10.1161/STROKEAHA.107.512202, 18556582.
24. Jang SH, Kim SH, Cho SH, Choi BY, Cho YW. Demonstration of motor recovery process in a patient with intracerebral hemorrhage. NeuroRehabilitation 2007, 22:141-145.
25. Ward NS, Newton JM, Swayne OB, Lee L, Thompson AJ, Greenwood RJ, Rothwell JC, Frackowiak RS. Motor system activation after subcortical stroke depends on corticospinal system integrity. Brain 2006, 129:809-819. 10.1093/brain/awl002, 16421171.
26. Cho SH, Kim SH, Choi BY, Kang JH, Lee CH, Byun WM, Jang SH. Motor outcome according to diffusion tensor tractography findings in the early stage of intracerebral hemorrhage. Neurosci Lett 2007, 421:142-146. 10.1016/j.neulet.2007.04.052, 17566651.
27. Sharma N, Cohen LG. Recovery of motor function after stroke. Dev Psychobiol 2012, 54:254-262. 10.1002/dev.20508, 22415914.
28. Gonzenbach RR, Taegtmeyer AB, Luft A, Russmann S. Fluoxetine and motor recovery after ischaemic stroke. Lancet Neurol 2011, 10:499-500. author reply 500-501.
29. Ruiz-Sandoval JL, Chiquete E, Garate-Carrillo A, Ochoa-Guzman A, Arauz A, Leon-Jimenez C, Carrillo-Loza K, Murillo-Bonilla LM, Villarreal-Careaga J, Barinagarrementeria F, Cantu-Brito C. Spontaneous intracerebral hemorrhage in Mexico: results from a Multicenter Nationwide Hospital-based Registry on Cerebrovascular Disease (RENAMEVASC). Rev Neurol 2011, 53:705-712.
30. Ferri CP, Schoenborn C, Kalra L, Acosta D, Guerra M, Huang Y, Jacob KS, Llibre Rodriguez JJ, Salas A, Sosa AL, Williams JD, Liu Z, Moriyama T, Valhuerdi A, Prince MJ. Prevalence of stroke and related burden among older people living in Latin America, India and China. J Neurol Neurosurg Psychiatry 2011, 82:1074-1082. 10.1136/jnnp.2010.234153, 3171978, 21402745.