E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025453 |
E.1.2 | Term | Major depressive disorder NOS |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
-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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of study is the date of the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |