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

• Conditions: Major Depressive Disorder; MedDRA version: 9.1Level: LLTClassification code 10057840Term: Major depression

• Registration Number: EUCTR2008-002319-42-IT
• Lead Sponsor: Eli Lilly and Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-03
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1160

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified