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

• Conditions: Major Depressive Disorder; MedDRA version: 8.1Level: LLTClassification code 10025453Term: Major depressive disorder NOS

• Registration Number: EUCTR2006-002404-34-LT
• Lead Sponsor: Pierre Fabre Médicament

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-14
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 534

Inclusion Criteria

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-TR 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

Exclusion Criteria

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, Social Phobia, 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-TR 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified