Major Depressive Disorder MedDRA version: 8.1 Level: LLT Classification code 10012378 Term: Depression
Conditions
Interventions
Trade Name: IXEL 25 mg
Product Name: Milnacipran
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Milnacipran hydrochloride
CAS N
Sponsors
Pierre Fabre Médicament - IRPF
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Out patient, aged 18 years to 70 years - Male, or female of childbearing potential using a medically accepted and well documented method of contraception (e.g. oral contraceptives, intrauterine devices, patch, contraceptive implant...) during 2 months before the inclusion in the study, documented sterility or postmenopause (one year amenorrhoea) - Meeting DSM IV-TR criteria for Major Depressive Disorder diagnosed using a structured interview (MINI) moderate or severe, recurrent, unipolar, without psychotic features - Total score MADRS > or = to 23 at selection and inclusion visits - Without any clinically relevant abnormalities in clinical examination, laboratory tests and ECG parameters - Patient having signed the written informed consent 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Psychiatric criteria - Patient at significant suicidal risk as assessed with the MINI 5.0.0 - section C - Resistance to two well-conducted antidepressant treatments (defined by the lack of response to at least two treatments prescribed at their optimal dose and during at least 4 weeks) for the current episode - Any history of psychotic episode or disorder - Any history of bipolar disorder - Any current panic disorder, agoraphobia, or obsessive compulsive disorder, generalised anxiety disorder or post traumatic stress disorder whose onset preceded the onset of the depressive disorder (diagnosis confirmed with MINI) . - Current major personality disorder of clinical significance or any other condition that might affect compliance (Cluster A, B and C ex: borderline, paranoid, histrionic, avoidant…) - History of alcohol and/or drug abuse and/or dependence, except tobacco according to DSM IV-TR criteria in the 12 months preceding inclusion Somatic criteria - Severe underlying or ongoing systemic disease that could interfere with the study - Fibromyalgia or chronic fatigue - Previous history of generalised or partial seizure - Organic cerebral disease - Known closed angle glaucoma - Cardiovascular disease including recent myocardial infarction, cardiac failure, post stroke, uncontrolled arterial hypertension - Known cardiac rhythm or conduction disorder - Hepatic insufficiency - Known prostatic disorder and/or dysuria - Renal failure - Pregnancy or breast-feeding - Gastrointestinal disorders (due to glucose and galactose malabsorption or lactase deficit) or congenital galactosemia - History of hemostasis disorders. Laboratory criteria - AST/SGOT and ALT/SGPT greater than 1.5 times the upper normal values - Creatinine > 150 µmol/L or documented creatinine clearence< 60 ml/min - Positive pregnancy test - Clinically relevant abnormal values according to the investigator's opinion for the other laboratory parameters ECG criteria - QT or QTc greater than the upper limit of the normal range - Clinically relevant abnormal values according to the investigator's opinion for the other ECG parameters Treatment related criteria - Known hypersensitivity or allergy to one of the study treatments - Non-response to milnacipran or venlafaxine for a previous episode - Previous treatment with Milnacipran or Venlafaxine for this episode - Patient involved in any other biomedical research currently or within the past 3 months - Electroconvulsive therapy in the 3 months preceding inclusion - Structured psychotherapy initiated within the past 6 weeks - Treatment with a depot-neuroleptic during the past 12 months - Chronic use (at least 5 days per week) of benzodiazepines in the past 3 months or initiation within the 3 months prior to D1, at doses strictly superior to 10 mg diazepam/day equivalent. - Chronic use (at least 5 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the percentage of responders in both treatment groups, Milnacipran or Venlafaxine administered up to 200 mg/day in flexible doses, during a treatment period of 8 weeks including up-titration, in out patients with Major Depressive Disorder.; Secondary Objective: - To assess safety in each treatment group. - To assess pain and anxiety symptoms associated with Major Depressive Disorder. ; Primary end point(s): Primary efficacy criterion: Decrease of 50.0% or more of the total score of MADRS between inclusion and last visit performed at the end of the treatment period at fixed dose (D56 or visit of premature withdrawal) | — |
Countries
France
Outcome results
None listed