Clinical trial NCT01870843: A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom
Official title: Improving Quality of Life and Social Functionality With Escitalopram in the Treatment of Major Depressive Disorder With Anxiety Symptom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Keywords: Depressive Disorder, Major
Depressive Disorder
Depression
Anxiety
Escitalopram
Quality of life
Social functionality
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56
timeFrame: Baseline, Day 14, Day 28, Day 42 and Day 56
measure: Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56
timeFrame: Baseline, Day 14, Day 28, Day 42, and Day 56
Secondary outcomes:
measure: Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
timeFrame: Day 7, Day 14, Day 28, Day 42 and Day 56
measure: Treatment Improvement Rate at the End of Week 1 and Week 2
timeFrame: Week 1 and Week 2
measure: Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
measure: Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
measure: Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56
timeFrame: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
measure: Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
timeFrame: Day 7, Day 14, Day 28, Day 42 and Day 56
measure: Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56
timeFrame: Day 7, Day 14, Day 28, Day 42 and Day 56
measure: Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56
timeFrame: Day 7, Day 14, Day 28, Day 42 and Day 56
Other outcomes:
Locations:
city: Beijing
country: China
city: Guangzhou
country: China
city: Hangzhou
country: China
city: Hohhot
country: China
city: Jinan
country: China
city: Kunming
country: China
city: Nanjing
country: China
city: Shijiazhuang
country: China
city: Urumqi
country: China
city: Xiamen
country: China
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: