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Una comparación doble ciego de tianeptina, imipramina y placebo en el tratamiento de episodios depresivos mayores

Published online by Cambridge University Press:  12 May 2020

G. B. Cassano ,
G. Heinze ,
H. Lôo ,
J. Mendlewicz ,
M. Paes de Sousa  and
en nombre del Grupo de Estudio
G. B. Cassano
Affiliation:
Instituto de Psiquiatría, Universidad de Pisa, Pisa, Italia;
G. Heinze
Affiliation:
Instituto Mexicano de Psiquiatría, San Lorenzo Huipulco Delegación Tlapan, Ciudad de México, México;
H. Lôo
Affiliation:
SHU, Hospital de Santa Ana, París, Francia;
J. Mendlewicz
Affiliation:
Laboratorio del Sueño, Departamento de Psiquiatría, Clínica Universitaria de Bruselas, Hospital Erasmo, Bruselas, Bélgica;
M. Paes de Sousa
Affiliation:
Departamento de Psiquiatría, Hospital de Santa María, Lisboa, Portugal
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Resumen

En el curso del desarrollo internacional de la tianeptina (T), 18 centros de Bélgica, Italia, México, Portugal, España y Suiza seleccionaron pacientes deprimidos en un estudio doble ciego de grupos paralelos frente a placebo (P) e imipramina (I). La eficacia y seguridad de la tianeptina se valoraron en 187 pacientes internos deprimidos (56% mujeres, 44% varones) que cumplían los criterios para depresión mayor, con episodio único (24,6%) o recurrente (6 6 ,8 %), o trastorno bipolar depresivo (8 ,6 %). Después de un periodo de rodaje de siete días con placebo previo a la inclusión, los pacientes recibieron tratamiento en condiciones de doble ciego con tianeptina (37,5 mg/d), imipramina (150 mg/d) o placebo durante 14 días, incluido un periodo de tres días de aumento diario de la dosis. Después del decimocuarto día y hasta el final de la sexta semana de tratamiento, se introdujo una dosis flexible de acuerdo con la eficacia terapéutica o los acontecimientos adversos potenciales (T: 25-50 mg/d; I: 100-200 mg/d; P: 2-4 cápsulas).

Keywords

depresióntianeptinaimipraminaplaceboensayo controlado
Type
Artículo original
Information
European Psychiatry (Ed. Española) , Volume 4 , Issue 3 , April 1997 , pp. 171 - 178
Copyright
Copyright © European Psychiatric Association 1997

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References

BIBLIOGRAFIA

American Psychiatric Association. Diagnostic and Statistical Manual o f Mental Disorders. DSM-III-R 3rd ed, revised. Washington, APA, 1987.Google Scholar
Angst, JBech, PBoyer, Pet al. Consensus conference on the methodology of clinical triais of antidepressants: report of the Consensus Committee, Zurich, March 1989.Google Scholar
Bobon, DP. Le systeme AMDP. Bruxelles: Mardaga P, 1982.Google Scholar
Chamba, GLemoine, PFlachaire, Eet al. Increased serotonin platelet uptake after tianeptine administration in depressed patients. Biol Psychiatry 1991; 30: 609-17.CrossRefGoogle ScholarPubMed
Chapuy, PCuny, GDelomier, YGalley, PMichel, JPPareaud, MMarey, C. La depression du sujet age. Interet de la tianeptine chez 140 patients traites pendant un an. Presse Med Paris 1991; 20: 1844-52.Google Scholar
Daniel, WW. Applied Nonparametric Statistics. Boston: Houghton Mifflin Company, 1978.Google Scholar
Davis, Jm. Antidepressant drugs. In: Kaplan, HISadock, BJ, eds. Comprehensive Texbook o f Psychiatry/IV. Baltimore, London, Los Angeles, Sidney: Williams and Wilkins, 1985: 1513-37.Google Scholar
Department o f Health and Human Services - Public Health Service Food and Drug Administration Memorandum from P Leber (Director of Division of Neuropharmacological Drug Products) lo Clinical Reviewers and Supervisors - November 5, 1985.Google Scholar
Derogatis, CRLipman, RSRickels, Ket al. The Hopkins Symptom Check-List (HSCL): a self-report symptom inventory. Behav Sci 1974; 19: 1-15.CrossRefGoogle Scholar
Gillings, DKoch, G. The application of the principie of intention-to-treat to the analysis of clinical triais. Drug Inf J 1991; 25: 411-24.CrossRefGoogle Scholar
Guelfi, JD. Efficacy of tianeprine in comparative triais versus reference antidepressants: an overview. Br J Psychiatry 1992; 160: (SUPPL 15): 72-5.CrossRefGoogle Scholar
Guelfi, JDDreyfus, JFLavoisy, J. A controlled study of viloxazine 300 mg sustained release capsules in depressed patients. Drug Invest 1992; 4: 83-8.CrossRefGoogle Scholar
Guelfi, JDDulcire, C, Le Moine, PTafani, A. Clinical safety and efficacy of tianeptine in 1858 depressed patients treated in general practice. Neuropsychobiology 1992; 25: 140-8.CrossRefGoogle ScholarPubMed
Guelfi, JDPichot, PDreyfus, JF. Efficacy of tianeptine in anxious-depressed patients: results of a controlled multicenter trial versus amitriptyline. Neuropsychobiology 1989; 22: 41-8.CrossRefGoogle ScholarPubMed
Guy, W, ECDEU (Early Clinical Drug Evaluation Unit). In: National Institute for Mental Heart, ed. Assessment Manual for Psychopharmacology. Washington, DC: National Institute for Mental Health, 1976.Google Scholar
Hamilton, M. The assessment of anxiety States by rating. Br J Psychology 1959; 32: 50-5.CrossRefGoogle ScholarPubMed
Invemizzi, GAguglia, EBertolino, Aet al. The efficacy and safety of tianeptine in the treatment of depressive disorder: results of a controlled double-blind multicentre study vs amitriptyline. Neuropsychobiology 1994; 30: 85-93.CrossRefGoogle Scholar
Kato, GWeitsch, AF. Neurochemical profile of tianeptine a new antidepressant drug. Clin Neuropharmacol 1988; 11 (suppl 2): S43-S50.Google ScholarPubMed
Kelly, JP, Leonard BE. The effect of tianeptine on the olfactory bulbectomize (OB) rat model of depression. Psychopharmacology 1990; 101 (suppl): S28.Google Scholar
Labrid, CMocaer, EKamoun, A. Neurochemical and pharmacological properties of tianeptine, a novel antidepresant. Br J Psychiatry 1992; 160 (suppl 15): 56-60.CrossRefGoogle Scholar
Labrid, CMoleyre, JPoignant, JCMalen, CMocaer, EKamoun, A. Structure-activity relationship of tricyclic antidepressants, with special reference to tianeptine. Clin Neuropharmacol 1988; 11 (suppl 2): S21-S31.Google ScholarPubMed
Lôo, HDavy, JPZarifian, E. Les antidépresseurs. In: Psychiatrie - Encycl M éd Chir. Paris: Elsevier, 1987; 37860 B70: 1-27.Google Scholar
Lôo, HGanry, HMarey, Cet al. Acceptabilité de la tianeptine chez 170 pat'ients déprimés traites un an. Encéphale 1990; 16; 445-52.Google Scholar
Lôo, HMalka, RDefrance, Ret, al. Tianeptine and amitriptyline: controlled double-blind trial in depressed alcoholic patients. Neuropsychobiology 1988; 19: 79-85.CrossRefGoogle ScholarPubMed
Mendlewicz, J. The social burden of depressive disorders. Neuropsychobiology 1989; 22: 178-80.CrossRefGoogle ScholarPubMed
Mennini, TGarattini, S. Effect of long-term treatment with antidepressants on 3H-serotonin uptake and 3H-imipramine binding in rat brain. J Recept Res 1987; 7: 1-4.Google Scholar
Mocaër, ERettori, MCKamoun, A. Pharmacological antidepressive effects and tianeptine-induced 5-HT uptake increase. Clin Neuropharmacol 1988; 11 (suppl 2): S32-S42.Google ScholarPubMed
Montgomery, SA. Clinically relevant effect sizes in depression. European Neuropsychopharmacology 1994; 4 (special issue).CrossRefGoogle Scholar
Montgomery, SA, Åsberg, M. A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134: 382-9.CrossRefGoogle ScholarPubMed
Olié, JPPoirier, AFLôo, H. Les maladies dépressives. Paris: Flammarion, 1995.Google Scholar
Ostaptzeff, G. Etude contrôlée à double-insu versus imipramine de Tefficacite de la tianeptine dans des états dépressifs non psychotiques. Biol Psychiatry 1981; 5: 597-600.Google Scholar
Pocock, JS. Clinical Triais. A Practical Approach. New York: Wiley and sons, 1983.Google Scholar
Poignant, JC. Etude pharmacologique d’un nouvel antidépresseur: la tianeptine. Biological Psychiatry 1981; 5: 573-8.Google Scholar
Renaud, B, Mocaër, EWeitsch, AFKato, GMennini, TGarattini, S. Stimulation of serotonin uptake induced by a new antidepressant. Pharmacopsychiatry 1988; 21: 66.Google Scholar
The rules goveming medicinal producis in the European Community: guidelines for antidepresant medicinal producis. January 1989.Google Scholar
Thiébot, MHMartin, PPuech, AJ. Animal behavioural studies in the evaluation of antidepressant drugs. Br J Psychiatry 1992; 160 (suppl 15): 44-50.CrossRefGoogle Scholar
Weiss, CGorceix, AKindynis, SDimitriu, M. Etude contrôlée à double-insu versus nomifensine de Tactivité et du délai d’action d’un nouvel antidépresseur la tianeptine. Biol Psychiatry 1981; 5: 593-6.Google Scholar
Whitton, PSSama, GSCurzon, G. Effects of tianeptine on stress-induced behavioural deficits and 5-HT dependent behaviour. Psychopharmacology 1991; 104:81-5.CrossRefGoogle ScholarPubMed
Winer, BJ. Statistical Principies in Experimental Design, 2nd edition. New York: McGraw-Hill, 1971.Google Scholar