Phase 4
Completed N=261
A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT01870843 ↗
Enrolled (actual)
261
Serious AEs
1.6%
Results posted
Jul 2016
Primary outcomePrimary: Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56 — 39.3; 9.6; 15.1; 19.0 Units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56 |
39.3; 9.6; 15.1; 19.0; 22.5 | — |
| PRIMARY Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56 |
17.4; -4.6; -7.0; -8.3; -10.1 | — |
| SECONDARY Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56 |
3.4; 16.3; 27.5; 43.3; 61.7 | — |
| SECONDARY Treatment Improvement Rate at the End of Week 1 and Week 2 |
98; 174 | — |
| SECONDARY Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56 |
29.1; -5.6; -10.5; -13.6; -16.4; -19.1 | — |
| SECONDARY Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56 |
25.6; -5.6; -10.1; -12.9; -15.1; -17.5 | — |
| SECONDARY Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56 |
14.9; -2.9; -4.7; -6.1; -7.4; -8.6 | — |
| SECONDARY Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56 |
7.2; 25.0; 46.7; 61.7; 74.2 | — |
| SECONDARY Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56 |
4.3; 15.8; 31.7; 43.8; 61.3 | — |
| SECONDARY Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56 |
7.5; 15.2; 27.0; 42.6; 51.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT01870843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.