Depressive Disorder, Major | A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom
Depressive Disorder, Major research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Depressive Disorder, Major
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:EscitalopramEscitalopram will be administered as oral tablets 10 mg per day 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
EscitalopramParticipants will receive 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.
Start Date: March 2014
Completed Date: May 2015
Phase: Phase 4
Primary Outcome: Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56
Secondary Outcome: Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
Study sponsors, principal investigator, and references
Principal Investigator: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.