A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression

Major Depressive Disorder Clinical Trial

Official title: A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of escitalopram treatment in participants with severe major depressive disorder (MDD [marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation]).

Clinical Trial Description

This is a single-arm (clinical study in only one group of participants), open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), and prospective (study following participants forward in time) study. The study consists of 2 parts: Screening (that is, 5 days before study commences on Day 1) and Treatment (that is, Week 1-8). All the eligible participants will be receiving flexible doses of escitalopram orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Efficacy will primarily be evaluated by remission rate at the end of the study. Participants' safety will be monitored throughout the study. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT01814085
• Study type: Interventional
• Source: Xian-Janssen Pharmaceutical Ltd.
• Status: Completed
• Phase: Phase 4
• Start date: February 2010
• Completion date: March 2012