Back to resultsA Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom
Primary Purpose
Depressive Disorder, Major
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder, Major focused on measuring Depressive Disorder, Major, Depressive Disorder, Depression, Anxiety, Escitalopram, Quality of life, Social functionality
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Escitalopram
Arm Description
Participants 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.
Outcomes
Primary Outcome Measures
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56
Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from "1 = very poor" to "5 = very good". The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening.
Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56
SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from "0 = unimpaired" to "30 = highly impaired". Higher scores indicate worsening.
Secondary Outcome Measures
Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
Remission rate is defined as percentage of participants with MADRS total scores less than or equal to 10 at the endpoint (at week 8). The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Treatment Improvement Rate at the End of Week 1 and Week 2
Onset of effect is defined as the reduction rate greater than or equal to 20 percent change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores. The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56
The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on a 7-point scale and the scores range from "0 = item not present/normal" to "6 = severe/continuous presence of the symptoms". Total score is calculated by adding the scores for all the 10 items and it ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56
HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from "0 to 56". The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and above 30 indicate very severe anxiety. Higher scores indicate worsening.
Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56
QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms.
Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
The MADRS is a 10 item scale designed to measure depression severity. Each item is scored on a 7 point scale and the scores range from "0 = item not present/normal" to "6 = severe/continuous presence of the symptoms". Total score is calculated by adding the scores for all the 10 items and ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; 35 to 60= severe depression data was obtained by Last observation carried forward (LOCF) method.
Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56
HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5 point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from "0 to 56". The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and 31 to 56 indicate very severe anxiety. Higher scores indicate worsening data was obtained by Last observation carried forward (LOCF) method.
Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56
QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms data was obtained by Last observation carried forward (LOCF) method.
Full Information
NCT ID
NCT01870843
First Posted
June 3, 2013
Last Updated
May 31, 2016
Sponsor
Xian-Janssen Pharmaceutical Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01870843
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xian-Janssen Pharmaceutical Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major
Keywords
Depressive Disorder, Major, Depressive Disorder, Depression, Anxiety, Escitalopram, Quality of life, Social functionality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
261 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
Escitalopram 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.
Primary Outcome Measure Information:
Title
Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56
Description
Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from "1 = very poor" to "5 = very good". The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening.
Time Frame
Baseline, Day 14, Day 28, Day 42 and Day 56
Title
Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56
Description
SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from "0 = unimpaired" to "30 = highly impaired". Higher scores indicate worsening.
Time Frame
Baseline, Day 14, Day 28, Day 42, and Day 56
Secondary Outcome Measure Information:
Title
Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
Description
Remission rate is defined as percentage of participants with MADRS total scores less than or equal to 10 at the endpoint (at week 8). The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Time Frame
Day 7, Day 14, Day 28, Day 42 and Day 56
Title
Treatment Improvement Rate at the End of Week 1 and Week 2
Description
Onset of effect is defined as the reduction rate greater than or equal to 20 percent change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores. The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Time Frame
Week 1 and Week 2
Title
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56
Description
The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on a 7-point scale and the scores range from "0 = item not present/normal" to "6 = severe/continuous presence of the symptoms". Total score is calculated by adding the scores for all the 10 items and it ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression.
Time Frame
Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
Title
Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56
Description
HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from "0 to 56". The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and above 30 indicate very severe anxiety. Higher scores indicate worsening.
Time Frame
Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
Title
Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56
Description
QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms.
Time Frame
Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56
Title
Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
Description
The MADRS is a 10 item scale designed to measure depression severity. Each item is scored on a 7 point scale and the scores range from "0 = item not present/normal" to "6 = severe/continuous presence of the symptoms". Total score is calculated by adding the scores for all the 10 items and ranges from "0 to 60". The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; 35 to 60= severe depression data was obtained by Last observation carried forward (LOCF) method.
Time Frame
Day 7, Day 14, Day 28, Day 42 and Day 56
Title
Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56
Description
HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5 point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from "0 to 56". The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and 31 to 56 indicate very severe anxiety. Higher scores indicate worsening data was obtained by Last observation carried forward (LOCF) method.
Time Frame
Day 7, Day 14, Day 28, Day 42 and Day 56
Title
Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56
Description
QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms data was obtained by Last observation carried forward (LOCF) method.
Time Frame
Day 7, Day 14, Day 28, Day 42 and Day 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
Organizational Affiliation
Xian-Janssen Pharmaceutical Ltd.
Official's Role
Study Director
Facility Information:
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
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom
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