A DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, PLACEBO-CONTROLLED 10-WEEK STUDY ASSESSING THE EFFICACY AND SAFETY OF F2695 SR FLEXIBLE DOSE (75,100 MG /DAY) IN THE TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE DISORDER EFFICACY AND TOLERANCE OF F2695 SR IN MAJOR DEPRESSIVE DISORDER

Pierre Fabre Médicament0 个研究点目标入组 534 人开始时间: 2006年8月22日最近更新: 2012年10月9日

适应症

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•male or female aged 18-70 years, Female of child bearing potential using a medically accepted method of contraception for at least 2 months before inclusion in the study or documented sterility or post-menopause (1 year amenorrhoea), out patient, meeting DSM-IV criteria for Major Depressive Episode diagnosed using a structured interview (MINI), moderate or severe, unipolar, without psychotic features, Duration of current episode: at least 1 month, with a HAM-D17 total score > 22 at selection and inclusion visits, with a Sheehan Disability Scale total score > or = 10 and with at least one score > or = 6 on one of the subscales at selection and inclusion visits, ithout any clinically relevant abnormalities in clinical examination, laboratory tests and ECG parameters
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patient at significant risk of suicide as assessed with the MINI§Resistance to two well-conducted antidepressant treatments (defined by a lack of response to at least 2 treatments prescribed at their effective dose and during at least 4 weeks ) for the current episode, Any history of bipolar disorder, psychotic episode or disorder, Any current Panic disorder, Agoraphobia, Obsessive compulsive disorder, Generalized anxiety or Post Traumatic Stress Disorder, when the onset preceded the onset of the depressive episoden, Current major personality disorder of clinical significance, History of alcohol or drug abuse according to DSM IV criteria within the 6 months preceding selection, Fibromyalgia Syndrome, Chronic Fatigue Syndrome, Severe underlying or ongoing systemic disease, Previous history of generalized or partial seizure, Cardiovascular disease including myocardial infarction, cardiac failure, uncontrolled arterial hypertension, Known cardiac rhythm or conduction disorder, Known prostatic disorder and/or dysuria, Known acute glaucoma, Hepatic insufficiency, Stroke or any organic cerebral disease, Pregnancy or breast-feeding, ECG: QT or QTc greater than the upper limit of the normal range, Non-response to milnacipran for a previous episode

发起方

Pierre Fabre Médicament