NCT01870843

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 6, 2013

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

June 3, 2013

Results QC Date

April 1, 2016

Last Update Submit

May 31, 2016

Conditions

Depressive Disorder, Major

Keywords

Depressive Disorder, MajorDepressive DisorderDepressionAnxietyEscitalopramQuality of lifeSocial functionality

Outcome Measures

Primary Outcomes (2)

  • 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.

    Baseline, Day 14, Day 28, Day 42 and Day 56

  • 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.

    Baseline, Day 14, Day 28, Day 42, and Day 56

Secondary Outcomes (8)

  • Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56

    Day 7, Day 14, Day 28, Day 42 and Day 56

  • Treatment Improvement Rate at the End of Week 1 and Week 2

    Week 1 and Week 2

  • Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56

    Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56

  • Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56

    Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56

  • Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56

    Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56

  • +3 more secondary outcomes

Study Arms (1)

Escitalopram

EXPERIMENTAL

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

Interventions

EscitalopramDRUG

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.

Escitalopram

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Beijing, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Hangzhou, China

Location

Unknown Facility

Hohhot, China

Location

Unknown Facility

Jinan, China

Location

Unknown Facility

Kunming, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Shijiazhuang, China

Location

Unknown Facility

Ürümqi, China

Location

Unknown Facility

Xiamen, China

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDepressive DisorderDepressionAnxiety Disorders

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Associate TA Manager
Organization
Xian-Janssen Pharmaceutical Ltd
ClinicalTrialDisclosure@its.jnj.com

Study Officials

  • Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

    Xian-Janssen Pharmaceutical Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 6, 2013

Study Start

March 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

July 11, 2016

Results First Posted

July 11, 2016

Record last verified: 2016-05

Locations

CN(10)