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A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom

Information source: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder, Major

Intervention: Escitalopram (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Xian-Janssen Pharmaceutical Ltd.

Official(s) and/or principal investigator(s):
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study Director, Affiliation: Xian-Janssen Pharmaceutical Ltd.


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.

Clinical Details

Official title: Improving Quality of Life and Social Functionality With Escitalopram in the Treatment of Major Depressive Disorder With Anxiety Symptom

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

Primary outcome:

Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF)

Change From Baseline in Sheehan Disability Scale (SDS)

Secondary outcome:

Remission Rate at Week 8

Onset of Effect Rate at Week 1

Onset of Effect Rate at Week 2

Change From Baseline to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Scores

Change From Baseline to Week 8 in Hamilton Anxiety Scale (HAMA) Scores

Change From Baseline to Week 8 in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Scores

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 of the study), single-arm (all participants receiving one intervention) study. Approximately 260 participants will be enrolled in this study. This study consists of two phases: screening phase and treatment phase. In the treatment phase, participants will receive escitalopram for 8 weeks: escitalopram 10 mg per day for 1 week and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment. Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination which will be monitored throughout the study. The total study duration will be approximately 2 years.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Beijing, China

Guangzhou, China

Hangzhou, China

Hohhot, China

Jinan, China

Kunming, China

Nanjing, China

Shijiazhuang, China

Urumqi, China

Xiamen, China

Additional Information

Starting date: March 2014
Last updated: July 1, 2015

Page last updated: August 23, 2015

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