E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Elderly depressed patients, MDD, DSM IV-TR, single episode or recurrent |
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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 |
To confirm a beneficial effect of escitalopram on depressive symptoms and on cognition and motor retardation in elderly depressed patients. |
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E.2.2 | Secondary objectives of the trial |
To assess the timeframe in which different aspects of the depressive disease get better; cognitive impairment could resolve faster compared to the core depressive symptoms. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• In- and outpatients • Depressed patients, MDD, DSM IV-TR, single episode or recurrent • GDS > 11 • Elderly patients > 65 years • MMSE score > 24
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E.4 | Principal exclusion criteria |
• The patient suffers from any condition (e.g. Parkinson's disease, dementia, psychotic disorders, mental retardation, substance- or alcohol abuse, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR) that might effect cognitive or fine motor processes or compromise the study in another way.
• The patient presents a personality disorder that might compromise the study.
• The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance. (If there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient’s participation in the study, the patient may be included).
• The patient uses the following disallowed recent or concomitant medication within the specified time periods:
- any antidepressant within the last week (5 weeks for fluoxetine, 2 weeks for fluvoxamine) prior to baseline.
- monoamine oxidase inhibitors (MAOIs) or reversible monoamine oxidase A inhibitors (RIMAs) within 2 weeks prior to baseline.
- any drug used for augmentation of antidepressant action within the last week prior to baseline.
- any anxiolytics (including benzodiazepines) within the last week prior to baseline.
- any hypnotics within the last week prior to baseline, except zolpidem, zopiclone or zaleplon which can be prescribed episodically for insomnia.
- oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline.
- serotonergic medicinal products (for example, triptans, tryptophan, tramadol) within the last week prior to baseline.
- Lithium or valproate or other mood stabilizers within 2 weeks prior to baseline.
- Electroconvulsive therapy within 6 months prior to baseline.
- Herbal remedies, which are psychoactive (for example, St. Johns Wort, kava kava, valerian, ginkgo biloba) within the last week prior to baseline.
- Any other drug with potential psychotropic effects within the last week prior to baseline.
- Any anticonvulsant drug within the last 2 weeks prior to baseline.
- Anticoagulants and/or medicinal products known to affect platelet function within the last 2 weeks prior to baseline.
- Potent inhibitors of CYP2C19 (for example, omeprazole) within the last 2 weeks prior to baseline.
- Cimetidine within the last week prior to baseline.
- Medicinal products that are predominantly metabolized by CYP2D6 if they have a narrow therapeutic index (for example, flecainide and propafenone) within the last 2 weeks prior to baseline.
- Any antihistaminics prior to baseline
- Any anitcholinergics prior to baseline.
• The patient has demonstrated a lack of response to previous treatment with citalopram or escitalopram (including current episode).
• The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or one of the ingredients.
• The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in GDS (Geriatric Depression Scale) and cognitive and psychomotor functioning during a 12 week Sipralexa treatment. |
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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 | 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 | No |
E.8.1.2 | Open | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
20 controls, matched for age, sex, education and vascular risk factors |
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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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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 | 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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Last patient last visit is considered as end of 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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |