E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive disorder (MDD) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025454 |
E.1.2 | Term | Major depressive disorder, recurrent episode |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053708 |
E.1.2 | Term | Major depressive disorder with melancholic features |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025453 |
E.1.2 | Term | Major depressive disorder NOS |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025463 |
E.1.2 | Term | Major depressive disorder, single episode |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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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 |
The primary objective of the trial is to compare effectiveness of EMC with TAU in the treatment of Major Depressive disorder (MDD) in non-improvers on day 14 (level 1 of The EMC Trial). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the trial are:
• to compare speed of recovery from MDD between EMC and TAU in non-improvers on day 14 (level 1 of The EMC trial)
• to compare the side effect profile and safety of EMC and TAU in non-improvers on day 14 (level 1 of The EMC trial).
• To compare changes in quality of life under EMC and TAU in non-improvers on day 14 (level 1 of The EMC trial).
• to compare effectiveness, speed of recovery from MDD, changes in quality of life and side effect profile in subgroups of improvers on day 14 (levels 2 and 3 of The EMC trial)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Major Depressive Disorder (MDD), first episode or recurrent, according to DSM-IV
• A HAMD17 score of ≥18 pts.
• Age between 18 and 65 years and age ≤ 60 years at the time of the first depressive episode
• Ability of subject to understand character and individual consequences of clinical trial
• Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
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E.4 | Principal exclusion criteria |
• Acute risk of suicide needing an intervention not comprised by protocol treatment (e.g. electroconvulsive therapy)
• Patients with a lifetime DSM-IV diagnosis of dementia, schizophrenia, schizoaffective disorder, bipolar disorder
• Patients with a current DSM-IV diagnosis of posttraumatic stress disorder, obsessive-compulsive disorder, anxiety disorder, or eating disorder and the requirement of a treatment not comprised by protocol treatment.
• Patients with DSM-IV substance dependency requiring acute detoxification.
• Depression due to organic brain disorder, e.g. Multiple Sclerosis and Parkinson’s Disease
• Women who are pregnant, breastfeeding or planning to become pregnant during the trial
• Women who are not sterile by surgery or for more than two years postmenopausal or women with childbearing potential who not practicing a medically accepted contraception during trial (reliable contraception are systemic contraceptives (oral, implant, injection), diaphragm or condoms with spermicide, sexual abstinence)
• A clear history of non-response to an adequate treatment trial in the current major depressive episode to any protocol antidepressant
• Patients currently taking antidepressant medication, which has been started within the 2-4 weeks prior to study begin and a continuation of this antidepressant medication is clinically indicated
• Medical or psychological condition that contraindicates the use of an investigational drug
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
• Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions may include gastrointestinal, cardiovascular, vascular disease (particularly brady- and tachyarrhythmia, QT interval prolongation, congenital long QT syndrome, Torsades de pointes, heart failure NYHA class IV, myocardial infarction), pulmonary/respiratory, hepatic impairment, renal, metabolic diseases (particularly hypokalaemia or hypomagnesaemia), endocrinological, neurological, immune-deficiency, hematopoietic disease, or malignancies as determined by medical history, physical examination, or laboratory tests.
• Participation in other clinical trials during the present clinical trial or within the last 6 months
• Medical or psychological condition that would not permit signing of informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Remission from MDD, defined as a HAMD-17 sum score ≤7 on day 56 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Response, defined as a HAMD17 sum score decrease ≥50% on day 56
- Absolute change of HAMD17 sum score [day 56-day 0]
- Remission defined as IDS score ≤ 11 on day 56
- Response defined as IDS score decrease ≥50% on day 56
- Time to remission and time to response according to IDS and HAMD17
- Remission from MDD, defined as a HAMD17 sum score ≤ 7 on day 56 (subgroups of improvers on day 14)
- Absolute change in SF12 subscales "physical component score" and "mental component score" [day 56-day 0]
- Occurrence of adverse events, UKU ratings at all visits, relevant laboratory data and deviations from normal ECG |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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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 | 3 |
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 | 0 |
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 |