E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Depression in the elderly |
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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 study is designed to establish the efficacy and tolerability of escitalopram in the treatment of depressive episodes of mild to moderate severity in the elderly. |
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E.2.2 | Secondary objectives of the trial |
1. To test if the GDS, the GRID HAM-D6 and the AQT are suited as tools to measure change of severity of depression during treatment. 2. To test the validity of self-report version of HAM-D6 in relation to the observer rated version 3. To test if there is difference in efficacy of escitalopram - when used to treat depressive disorders in elderly patients - in relation to pre-existing cognitive dysfunction
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• All in- or out-patients of 65 years of age or above fulfilling the ICD-10 diagnosis of depressive single episode (F32.00-32.11. 32.8 or 32.9), depressive recurrent episode (F33.00-33.11, 33.8 or 33.9) or organic depressive episode (F06.32). DSM-4 criteria will be registered but will not be used for in- or exclusion • The depressive state should be mild to moderate and reach a score on HAM-D6 of ≥ 7 and ≤ 11 • Patients with dementia can be included provided they have a MMSE score of ≥ 17
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E.4 | Principal exclusion criteria |
• Patients with a current depressive episode of a severity reaching a score of ≥ 12 on the HAM-D6-item depression factor. This is to exclude patients with a severe or psychotic depression • Patients with suicidal thoughts or behaviour • Patients with conditions where treatment with escitalopram is contraindicated: e.g. hypersensitivity to escitalopram or other contents of escitalopram tablets, concomitant treatment with non-selective, irreversible mono-amine-oxidase inhibitors, Marplanī • Patients who in the current depressive episode have had a failed trial of treatment with escitalopram • Co-morbid dementia with a severity corresponding to a score on the MMSE of less than 17 as these patients will often be without the ability to give informed consent. • Patients with sensory defects rendering psychometric assessment impossible, e.g. deafness, blindness, severe aphasia • Patients who cannot speak Danish well enough to make psychometric assessment possible and meaningful • Patients with congenital or early acquired intellectual deficits
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E.5 End points |
E.5.1 | Primary end point(s) |
Remission during the study is defined as a HAM-D6 score below 3 Response will be defined as a drop in HAM-D6 score of 50 % or more
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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 | No |
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 | Information not present in EudraCT |
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 | 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 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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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The end of the trial is 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 | |
E.8.9.1 | In the Member State concerned days | |