RESUMO
1,927 outpatients were included by 392 general practitioners in an open study in order to evaluate the safety of tianeptine in the ambulatory treatment of depression. The results of 1,858 depressed patients without melancholia and psychotic features, fulfilling DSM III criteria of Major Depressive Episode or Dysthymic Disorder, could be analysed. 1,458 patients completed the 3-month treatment period. The group treated with 37.5 mg/day of tianeptine showed improvement on the Montgomery-Asberg Depression Rating Scale. With regard to the clinical tolerance of tianeptine, somatic complaints were rarely reported and adverse events necessitating premature termination of treatment (4.8% of included patients) were without clinical severity. Cardiovascular, haematologic, hepatic and biochemical safety were verified. No signs of dependence and no specific withdrawal symptoms were found after discontinuation of treatment.
Assuntos
Antidepressivos Tricíclicos/uso terapêutico , Transtorno Depressivo/tratamento farmacológico , Tiazepinas/uso terapêutico , Antidepressivos Tricíclicos/efeitos adversos , Transtorno Depressivo/psicologia , Eletrocardiografia , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Pacientes Ambulatoriais , Escalas de Graduação Psiquiátrica , Síndrome de Abstinência a Substâncias/psicologia , Suicídio , Tiazepinas/efeitos adversosRESUMO
In a double-blind, placebo-controlled, crossover study, the effects of therapeutic doses of the new tricyclic antidepressant tianeptine on cardiovascular function were closely monitored in 21 healthy volunteers during a 2-week treatment period. Blood pressure measurements, ECG recording, 24-h Holter monitoring, and echocardiography were carried out at 1-week intervals. Isotopic ventriculography was measured twice under each treatment. Tianeptine did not produce orthostatic hypotension or increase heart rate. No ECG changes could be observed and the cardiac conduction time remained unchanged. One subject presented with an increase in frequency of ventricular premature beats that could not be definitely attributed to the drug. Cardiac output assessed at rest and after a bicycle exercise stress test was not altered. The present study suggests that tianeptine is a tricyclic antidepressant endowed with less cardiac toxicity than classical tricyclic antidepressants.
Assuntos
Antidepressivos Tricíclicos/efeitos adversos , Hemodinâmica/efeitos dos fármacos , Tiazepinas/efeitos adversos , Adulto , Angiocardiografia , Antidepressivos Tricíclicos/sangue , Método Duplo-Cego , Ecocardiografia , Eletrocardiografia , Frequência Cardíaca/efeitos dos fármacos , Ventrículos do Coração/efeitos dos fármacos , Humanos , Masculino , Pessoa de Meia-Idade , Distribuição Aleatória , Tiazepinas/sangueRESUMO
Numerous authors insist on the need for prolonged prescription of antidepressant drugs. Legislation develops and now requires long-term controls for psychotropic drugs. In order to assess long-term efficacy and safety of tianeptine, a clinical trial was undertaken with the objective of 100 patients completing one year of treatment. This multicentered study involves 157 psychiatrists all over France, under the responsibility of a national coordinator and 19 regional coordinators. The methodology is explained, as well as the various means that have been planned to set up the protocol, to follow the case reports and to analyse the results. The use of a central computer assisted monitoring and the organization of national and regional meetings with the investigators seem to take an important part in the management of the study. Preliminary results after 6 months of treatment for 478 patients are discussed. They confirm the prolonged efficacy and the safety of tianeptine. The effective contribution made by the logistic support should allow the study to reach its objectives. When completed, it should be a pilot study for further long-term studies with antidepressants.
Assuntos
Antidepressivos Tricíclicos/uso terapêutico , Tiazepinas/uso terapêutico , Adulto , Idoso , Idoso de 80 Anos ou mais , Ensaios Clínicos como Assunto , Comportamento do Consumidor , Depressão/classificação , Depressão/tratamento farmacológico , Eletroencefalografia , Feminino , França , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Fatores de TempoRESUMO
The evaluation of clinical and paraclinical safety of tianeptine was performed in (a) clinical pharmacology studies assessing night sleep EEG organization; electrocardiographic stability by continuous 24-h recordings (Holter's method); ocular tonus in patients with stabilized glaucoma; salivary flow; prolactin secretion; photodynamic dermatologic reactions; cerebral electrical activity; hematologic, hepatic, renal and main metabolic parameters; separately, withdrawal phenomena and addictive potential were searched for in drug addicts; (b) double-blind controlled studies versus reference compounds. The results confirm that the therapeutic safety of tianeptine is satisfactory with respect to clinical side effects and paraclinical parameters. Tianeptine does not induce sedation and thus does not disturb the recovery of active life. It does not induce anticholinergic effects (dry mouth, constipation, etc.), even in elderly subjects. It is devoid of heart and blood pressure side effects including postural hypotension tachycardia, ECG abnormalities, and especially atrioventricular or intraventricular conduction disorders. Moreover, tianeptine does not disturb the hematologic, renal, hepatic parameters, even in alcoholic patients in the detoxification period. It does not induce physical or psychological signs of dependence when discontinued, even in alcoholic patients or drug addicts. No abuse of tianeptine and no tolerance were noted in detoxified opiate addicts.