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

• ClinicalTrials.gov Identifier: NCT01870843
• Recruitment Status: Completed
• First Posted: June 6, 2013
• Results First Posted: July 11, 2016
• Last Update Posted: July 11, 2016
• Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Information provided by (Responsible Party): Xian-Janssen Pharmaceutical Ltd.

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.

Condition or disease	Intervention/treatment	Phase
Depressive Disorder, Major	Drug: Escitalopram	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 261 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Improving Quality of Life and Social Functionality With Escitalopram in the Treatment of Major Depressive Disorder With Anxiety Symptom
• Study Start Date: March 2014
• Actual Primary Completion Date: May 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Escitalopram; 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.	Drug: Escitalopram; 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.

Outcome Measures

Primary Outcome Measures :

1. Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56 [ Time Frame: Baseline, Day 14, Day 28, Day 42 and 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.
2. Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56 [ Time Frame: Baseline, Day 14, Day 28, Day 42, and 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 :

1. Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56 [ Time Frame: Day 7, Day 14, Day 28, Day 42 and 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.
2. Treatment Improvement Rate at the End of Week 1 and Week 2 [ Time Frame: 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.
3. Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56 [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42 and 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.
4. Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56 [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42 and 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.
5. Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56 [ Time Frame: Baseline, Day 7, Day 14, Day 28, Day 42 and 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.
6. Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56 [ Time Frame: Day 7, Day 14, Day 28, Day 42 and 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.
7. Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56 [ Time Frame: Day 7, Day 14, Day 28, Day 42 and 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.
8. Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56 [ Time Frame: Day 7, Day 14, Day 28, Day 42 and 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

China

Beijing, China

Guangzhou, China

Hangzhou, China

Hohhot, China

Jinan, China

Kunming, China

Nanjing, China

Shijiazhuang, China

Urumqi, China

Xiamen, China

Sponsors and Collaborators

Xian-Janssen Pharmaceutical Ltd.

Investigators

• Study Director: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial; Xian-Janssen Pharmaceutical Ltd.

More Information

• Responsible Party: Xian-Janssen Pharmaceutical Ltd.
• ClinicalTrials.gov Identifier: NCT01870843
• Other Study ID Numbers: CR100826; ESCITALDEP4005 ( Other Identifier: Xian-Janssen Pharmaceutical Ltd., China ); ESC-C-11-CN-002-V04 ( Other Identifier: Xian-Janssen Pharmaceutical Ltd., China )
• First Posted: June 6, 2013
• Results First Posted: July 11, 2016
• Last Update Posted: July 11, 2016
• Last Verified: May 2016

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:

Depressive Disorder, Major; Depressive Disorder; Depression; Anxiety; Escitalopram; Quality of life; Social functionality

Additional relevant MeSH terms:

Disease; Depressive Disorder; Depression; Depressive Disorder, Major; Pathologic Processes; Mental Disorders; Mood Disorders; Behavioral Symptoms; Citalopram; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs