Exploratory study of the efficacy and safety of flexible doses of Milnacipran and Venlafaxine administered in out patients with Major Depressive Disorder.

• Register: EUCTR
• Last refreshed on: 10 December 2019
• Main ID: EUCTR2006-003658-47-FR
• Date of registration: 25/08/2006
• Prospective Registration: Yes
• Primary sponsor: Pierre Fabre Médicament - IRPF
• Public title: Exploratory study of the efficacy and safety of flexible doses of Milnacipran and Venlafaxine administered in out patients with Major Depressive Disorder.
• Scientific title: Exploratory study of the efficacy and safety of flexible doses of Milnacipran and Venlafaxine administered in out patients with Major Depressive Disorder.
• Date of first enrolment: 21/11/2006
• Target sample size: 180
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003658-47
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France

Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Major Depressive Disorder
MedDRA version: 8.1 Level: LLT Classification code 10012378 Term: Depression

Intervention(s)

Trade Name: IXEL 25 mg
Product Name: Milnacipran
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Milnacipran hydrochloride
CAS Number: 92623-85-3
Current Sponsor code: F2207
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25 -

Trade Name: IXEL 50 mg
Product Name: Milnacipran
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Milnacipran hydrochloride
CAS Number: 92623-85-3
Current Sponsor code: F2207
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: EFFEXOR 25 mg
Product Name: Venlafaxine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Venlafaxine
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 25-

Trade Name: EFFEXOR 50 mg
Product Name: Venlafaxine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Venlafaxine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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)

Secondary Objective: - To assess safety in each treatment group.
- To assess pain and anxiety symptoms associated with Major Depressive Disorder.

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 ID(s)

F02207 GE 3 03

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 21/07/2016
• Date Completed: 15/04/2008
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2006-003658-47/results