Status:
COMPLETED
A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the impact of escitalopram on quality of life and social functionality in patients with major depressive disorder with anxiety symptom.
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center, prospective (a study in which the participants are identified and then followed forward in time for the outcome ...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder according to the American Psychiatric Association's Diagnostic and Statistical Manual-IV, Text Revision (DSM-IV-TR) diagnostic criteria
- Minimum scores of 9 on Sheehan Disability Scale
- Minimum scores of 14 on Hamilton Anxiety Scale
Exclusion
- History of primary or comorbid diagnoses of schizophrenia, schizoaffective disorder, bipolar disorder, or dementia
- Presence of unstable serious illness and/or has a clinically significant renal or hepatic impairment, seizure disorders or any other disease which may be detrimental to the participant or the study
- Participant who have continuously taken psychoactive substances, antidepressants, anxiolytics, Monoamine oxidase inhibitors, psychoactive herbal remedies, lithium, electroconvulsive therapy, carbamazepine in the past 2 weeks before the baseline visit
- Diagnosis of major depressive disorder who currently require treatment systematically within past 2 months from baseline
- Receiving pharmacological treatment, which is disallowed in the current approved Chinese summary of product characteristics for escitalopram
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT01870843
Start Date
March 1 2014
End Date
May 1 2015
Last Update
July 11 2016
Active Locations (10)
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1
Beijing, China
2
Guangzhou, China
3
Hangzhou, China
4
Hohhot, China