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

Eli Lilly and Company Limited0 sites1,160 target enrollmentDecember 16, 2008

Overview

No summary available.

Registry

who.int

Start Date

December 16, 2008

End Date

March 8, 2010

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•(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

•\[7] Have any current primary Axis I disorder other than MDD
•\[8] Have a diagnosis of dementia, Alzheimer’s disease, or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent 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
•\[11] Are demonstrating a response or demonstrated a response to the AD 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
•\[13] Are employed by Lilly or Boehringer Ingelheim (BI)
•\[14] Women of childbearing potential who are not using a medically accepted means of contraception. 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\.