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.
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.
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 8Onset 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
|