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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Xian-Janssen Pharmaceutical Ltd.
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier:
NCT01870843
First received: June 3, 2013
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Depressive Disorder, Major
Drug: Escitalopram
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Xian-Janssen Pharmaceutical Ltd.:

Primary Outcome Measures:
  • Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 6, and Week 8 ] [ Designated as safety issue: No ]
    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 From Baseline in Sheehan Disability Scale (SDS) [ Time Frame: Baseline, Week 2, Week 4, Week 6, and Week 8 ] [ Designated as safety issue: No ]
    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 at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Remission rate is defined as percentage of participants with Montgomery-Asberg Depression Rating Scale (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) will range 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.

  • Onset of Effect Rate at Week 1 [ Time Frame: Week 1 ] [ Designated as safety issue: No ]
    Onset of effect will be 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) will range 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.

  • Onset of Effect Rate at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    Onset of effect will be 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) will range 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 From Baseline to Week 8 in Montgomery-Asberg Depression Rating Scale (MADRS) Scores [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 will range 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 From Baseline to Week 8 in Hamilton Anxiety Scale (HAMA) Scores [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    HAMA 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 will range 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 From Baseline to Week 8 in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Scores [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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 or over (very severe depression). Higher scores represent more severe depression symptoms.


Estimated Enrollment: 260
Study Start Date: March 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870843

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
China
Not yet recruiting
Beijing, China
Not yet recruiting
Guangzhou, China
Recruiting
Hangzhou, China
Not yet recruiting
Hohhot, China
Recruiting
Jinan, China
Not yet recruiting
Kunming, China
Recruiting
Nanjing, China
Recruiting
Shijiazhuang, China
Not yet recruiting
Urumqi, China
Recruiting
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

Additional Information:
No publications provided

Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01870843     History of Changes
Other Study ID Numbers: CR100826, ESCITALDEP4005, ESC-C-11-CN-002-V04
Study First Received: June 3, 2013
Last Updated: September 17, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xian-Janssen Pharmaceutical Ltd.:
Depressive Disorder, Major
Depressive Disorder
Depression
Anxiety
Escitalopram
Quality of life
Social functionality

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 01, 2014