Status:
COMPLETED
An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Depressive Disorder, Major
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief 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.
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 hospi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 7 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2011
Estimated Enrollment :
318 Patients enrolled
Trial Details
Trial ID
NCT01814098
Start Date
July 7 2009
End Date
November 30 2011
Last Update
October 2 2017
Active Locations (10)
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1
Beijng, China
2
Changsha, China
3
Hangzhou, China
4
Nanjing, China