Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement to Escitalopram Treatment: Early vs. Delayed Intervention Strategy - ND

• Register: EUCTR
• Last refreshed on: 2 October 2012
• Main ID: EUCTR2008-002319-42-IT
• Date of registration: 03/10/2008
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company Limited
• Public title: Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement to Escitalopram Treatment: Early vs. Delayed Intervention Strategy - ND
• Scientific title: Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement to Escitalopram Treatment: Early vs. Delayed Intervention Strategy - ND
• Date of first enrolment: 20/10/2008
• Target sample size: 1160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002319-42
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: yes Other specify the comparator: strategia di intervento precoce vs ritardata

Countries of recruitment

Denmark, France, Greece, Hungary, Italy, Netherlands, Spain, Sweden

Key inclusion & exclusion criteria

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia. [8] Have a diagnosis of dementia, Alzheimer?s 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 patient?s baseline (visit 1) HAMD17 scores on item 3 suicide are 3.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Major Depressive Disorder
MedDRA version: 9.1 Level: LLT Classification code 10057840 Term: Major depression

Intervention(s)

Trade Name: CYMBALTA
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Duloxetine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: CIPRALEX
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Escitalopram
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Trade Name: CYMBALTA
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Duloxetine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

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.

Main Objective: 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.

Secondary Objective: 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.

Secondary ID(s)

2008-002319-42-NL

F1J-EW-HMGD