NCT01814085

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Xian-Janssen Pharmaceutical Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Escitalopram	Escitalopram tablets will be administered orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Dose can be adjusted as per Investigator's discretion depending on participant's response.

Timeline

• Start date: 2010-02-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2013-03-19
• Last updated: 2014-01-03

Locations

6 sites across 1 country: China