E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Major Depressive Disorder |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057840 |
E.1.2 | Term | Major depression |
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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 |
This study has two primary objectives, (1) to test the hypothesis that time to confirmed response is shorter in the early intervention strategy vs. the delayed intervention strategy, among patients identified as suffering from MDD with a lack of improvement after 4 weeks of escitalopram treatment and (2) to test the hypothesis that time to confirmed remission will be shorter in the early compared with the delayed strategy. The second objective will be tested according to a gatekeeper strategy meaning that it will be tested only if the null hypothesis for the first objective (time to confirmed response) is rejected at the 5% 2-tailed level of statistical significance. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are as follows: To compare the efficacy of both intervention strategies as measured by time to: o Confirmed response as defined by ≥50% reduction in baseline Quick Inventory of Depressive Symptomatology - Self-reported score (QIDS-SR) that is maintained for two consecutive visits. o Confirmed remission as defined by a QIDS-SR score of ≤5 (secondary outcome) that is maintained for two consecutive visits. To compare the efficacy of both intervention strategies throughout the study as measured by the Clinical Global Impression-Severity (CGI-S) rating scale. To compare the improvement of painful symptoms throughout the study for both intervention strategies as measured by the visual analog scale (VAS) score for overall pain severity. Assessments of pain improvement will be restricted to subjects presenting with at least a modest level of pain as indicated by a baseline VAS score of > 30. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
[1] Male or female outpatients of at least 18 years of age who meet criteria for MDD, single or recurrent episode according to the DSM-IV-TR disease diagnostic criteria. [2] Patients (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current AD treatment to escitalopram for this current MDD episode, at Visit 1. [3] Must have a baseline score of ≥19 on the HAM-D17 at visit 1. [4] Must have a baseline score of ≥ 4 in the Clinical Global Impression- Severity (CGI-S) at visit 1. [5] Have a level of understanding sufficient to provide ICD, and to communicate with the investigators and site personnel. [6] Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol. |
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E.4 | Principal exclusion criteria |
Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia. [8] Have a diagnosis of dementia, Alzheimers disease, or organic brain syndrome; or who are cognitively impaired or who have language problems that prevents them from understanding and/or providing valid answers to the rating scale contents. [9] Concomitant participation in other studies with investigational or marketed products. [10] Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness (for instance, change of residence or healthcare center of reference). [11] Are demonstrating a response or demonstrated a response to the antidepressant treatment for the current depression episode previous to baseline visit. [12] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [13] Are employed by Lilly or Boerhinger Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [14] Women of childbearing potential who are not using a medically accepted means of contraception (for example, intrauterine device, oral contraceptive, contraceptive patch, implant, Depo-Provera [medroxyprogesterone acetate injectable suspension, Pharmacia & Upjohn], or barrier devices) when engaging in sexual intercourse. Women who are pregnant or breast-feeding may not participate in the study. [15] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. [16] Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the patients baseline (visit 1) HAMD17 scores on item 3 suicide are 3. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Time to confirmed response is defined as the time from the day of study randomization (visit 2)to the date of first observation of confirmed response defined as a ≥50% baseline score reduction on the HAMD17 for two consecutive visit. Time to confirmed remission is defined as the time from the day of study randomization (visit 2)to the date of first observation of confirmed remission defined as a score on the HAMD17 of ≤ 7 for two consecutive visit. |
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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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
strategia di intervento precoce vs ritardata |
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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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 59 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
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 | 7 |