E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder (MDD) remains to be under-recognized and under-treated, though it is amongst the leading causes of disease burden worldwide. Despite the proven efficacy of modern antidepressants, response rates are still unsatisfying, since a substantial number of patients shows only limited response or fails to respond at all and high risk of relapse remains even when remission is achieved.
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MedDRA Classification |
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 this study is to relate functional and structural MR parameters (e.g. local and system level BOLD signal, gray matter, structural connectivity, surface and parcellation measures) to drug response and remission.
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E.2.2 | Secondary objectives of the trial |
A further objective of this study is the investigation of the potential use of mRNA expression levels of SLC6A4, BDNF and HTR1A and serotonin uptake as peripheral correlates of neural markers of drug response. An additional objective of this study is to relate genetic variation of SLC6A4, BDNF and HTR1A to neuronal makers of treatment response (e.g. amygdala response differs between responders and non-responders as a function of genotype).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• willingness and competence to sign the informed consent form voluntarily. • aged 18 – 45 years • right-handedness • a DSM-IV diagnosis of a major depressive episode by a structured clinical interview (SCID) • a MADRS score ≥20 and ≤ 30 • ability to be managed as outpatients • ability to fulfill the criteria to undergo an MRI scan • Caucasian subjects of European ancestry
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E.4 | Principal exclusion criteria |
• previous or concurrent major medical or neurological illness • clinically significant abnormal values in routine laboratory screening or general physical examination • DSM-IV diagnosis of substance dependence within the past year, except for caffeine or nicotine or current substance abuse • DSM-IV diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or an anxiety disorder as a primary diagnosis • the use of any psychotropic drug within the last two months • unresponsiveness of a former major depressive episode to an adequate antidepressive drug dosing of at least 6 weeks duration or any kind of therapy resistance • a history of severe drug allergy or hypersensitivity or known hypersensitivity to escitalopram • being acutely suicidal either indicated by a score ≥ 5 on item 10 (suicidal thoughts) on the MADRS or a score ≥ 4 on the HAM-D 21 (suicidal thoughts) or according to the investigator´s opinion • failures to comply with the study protocol or to follow the instructions of the investigating team • current pregnancy or breast feeding; • metallic implants or other contraindications to MRI
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary outcome variables are functional and structural MRI parameters dependent on drug response and remission. |
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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 | No |
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 | No |
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 | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | Information not present in EudraCT |
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
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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 | 2 |
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 | 2 |
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 |