Major Depressive Disorder
Conditions
Interventions
Product Name: F2695
Product Code: F2695SR
Pharmaceutical Form: Prolonged-release capsule, hard
Pharmaceutical form of the placebo: Prolonged-release capsule, hard
Route of administration of the placeb
Sponsors
Pierre Fabre Médicament
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
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, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the clinical efficacy of F2695 SR flexible dose (75, 100 mg /day) compared to placebo in patients with MDD through the assessment of MADRS after 10 weeks of treatment.;Secondary Objective: -To assess the efficacy of F2695 SR flexible dose (75, 100 mg /day) versus placebo through the assessment of CGI improvement, Sheehan Disability Scale, HAM-D17 and COVI scale after 10 weeks of treatment, - To assess the efficacy of F2695 SR flexible dose (75, 100 mg/day) versus placebo on somatic complaints through the assessment of Visual Analog Scales after 10 weeks of treatment. -To assess the safety of F2695 SR flexible dose (75, 100 mg /day) versus placebo.;Primary end point(s): Change in MADRS total score from baseline to Day 70. Main efficacy analysis: MMRM (likelihood-based Mixed-effects Model Repeated Measures) analysis on MADRS total score changes from baseline over time with Treatment, Centre, Visit as categorical fixed factors, MADRS total score baseline as covariate, and, treatment-by-visit and baseline-by-visit interactions on the Full Analysis Set. Appropriate contrasts on treatment factor and treatment-by-visit interaction to estimate the difference between treatment group in mean change from baseline to D70. | — |
Countries
Czech Republic, Estonia, Finland, Germany, Latvia, Lithuania, Sweden
Outcome results
None listed