An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms
Information source: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depressive Disorder, Major
Intervention: Escitalopram (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Xian-Janssen Pharmaceutical Ltd. Official(s) and/or principal investigator(s): Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study Director, Affiliation: Xian-Janssen Pharmaceutical Ltd.
Summary
The purpose of this study is to evaluate the efficacy and safety of long term escitalopram
treatment in participants with Major Depressive Disorder (MDD) with associated anxiety
symptoms.
Clinical Details
Official title: Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Percentage of Participants With Remission According to Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAM-A)
Secondary outcome: Percentage of Participants Showing ResponseChange From Baseline in MADRS Total Score at Week 24 Change From Baseline of Single Rating Item in MADRS Total Score at Week 24 Change From Baseline in Hamilton Depression Rating Scale (HAMD)-17 Score at Week 24 Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24 Change From Baseline of Single Rating Item in HAM-A at Week 24 Change From Baseline in Clinical Global Impression Score (CGI-S) at Week 24 Change From Baseline in Short Form-12 (SF-12) Score at Week 24
Detailed description:
This is an open-label (all people know the identity of the intervention), single arm,
prospective (study following participants forward in time), post-marketing, multi-center
(when more than one hospital or medical school team work on a medical research study) study
to evaluate the efficacy and safety of escitalopram in participants with MDD with associated
anxiety symptoms. The duration of the study will be 24 weeks at a starting dose of
escitalopram 10 milligram per day (mg/day). The dose will be flexibly adjusted (maximum 20
mg/day) after 2 weeks of treatment depending on Investigator's discretion. The study will
consist of 9 visits: Baseline, Week 1, 2, 4, 8, 12, 16, 20 and 24. Assessments of efficacy
and safety will be performed at each visit. The primary efficacy evaluation will be done by
Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale(HAM-A).
Participant's safety will also be monitored throughout the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participant must be willing and able to give written informed consent
- Participant currently suffering from Major Depressive Disorder (MDD) with anxious
symptoms including participant with first MDD episode, and relapsed participant with
new episode
- Participant with minimum score at baseline of 22 on the Montgomery-Asbery Depression
Rating Scale (MADRS) and minimum score at baseline of 14 on Hamilton Anxiety Rating
(HAM-A) scales
- Female participant must be surgically sterile, or practicing an effective method of
birth control before entry and throughout the study
Exclusion Criteria:
Participant who has continuously taken psychoactive substances, antidepressants,
anxiolytics, monoamine oxidase inhibitors (MAOIs), psychoactive herbal remedies, lithium,
electroconvulsive therapy (ECT) carbamazepine in the past 2 weeks before the baseline
visit - Participants with MDD, requiring treatment systematically within past 2 months
from baseline - Participants who has contraindication to escitalopram - Participant has
primary or comorbid diagnoses of schizophrenia (psychiatric disorder with symptoms of
emotional instability, detachment from reality, often with delusions and hallucinations
[imagining things], and withdrawal into the self), schizoaffective disorder (a mixed
psychiatric disorder relating to a complex psychotic state that has features of both
schizophrenia and a mood disorder such as bipolar disorder), bipolar disorder, or dementia
(mental decline) - Participant who has a significant risk of suicide on clinical
assessment or has made a serious suicide attempt within the past 6-month
Locations and Contacts
Beijng, China
Changsha, China
Hangzhou, China
Nanjing, China
Shanghai, China
Shenyang, China
Shijiazhuang, China
Tianjin, China
Wenzhou, China
Wuhan, China
Additional Information
Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom
Starting date: July 2009
Last updated: May 30, 2014
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