E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 explore alterations in brain metabolism by means of 18F-FDG PET in relation to information processing ratings, in patients with major depression treated with 8 wks escitalopram |
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E.2.2 | Secondary objectives of the trial |
To explore cross-sectional differences in brain metabolism of depressed patients compared to healthy volunteers (normal database) before and after treatment with escitalopram To explore the influence of 2 and 8 wks escitalopram treatment on information processing (attentional bias, autobiographical memory, future fluency, facial recognition) in patients with major depression To explore the influence of 2 and 8 weeks escitalopram treatment on depression, anxiety and hopelessness ratings in patients with major depression
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Functional Neuroimaging in depression: longitudinal study of PET metabolism in correlation with changes in attentional bias, autobiographical memory, future fluency and facial recognition in depressed patients treated with escitalopram - Substudy - version 1.0, 09 June 2009. To compare the results of the information processing assessments of the study population with the results of a corresponding control group in terms of age, gender and education. |
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E.3 | Principal inclusion criteria |
Major Depression, Depressive episode, following DSM-IV criteria (SCID-I) MADRS-score > 25 Inpatients (at inclusion) and outpatients Age: 18-65 yrs Medication-free or Anti-depressant wash-out 7 days (fluoxetine 6 weeks) Lorazepam 1mg or zolpidem 10mg are allowed
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E.4 | Principal exclusion criteria |
Bipolar disorder, following DSM-IV criteria (SCID-I) Personality disorder, following DSM-IV criteria (SCID-II) Diabetes mellitus Women without anticonceptive protection, pregnancy or breast feeding Pharmacological treatment or ingestion of substance that can influence cerebral perfusion less than a month before inclusion Psychotic symptomsSubstance abuse IQ below 80 Cognitive dysfunction due to trauma capitis or dementia
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the effect of the antidepressant escitalopram on cognitive functions and brain metabolism in depressed patients. |
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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) | 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 | 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.8.5 | 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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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 | |
E.8.9.2 | In all countries concerned by the trial years | 2 |