Status:
COMPLETED
A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
Lead Sponsor:
Xian-Janssen Pharmaceutical Ltd.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of escitalopram treatment in participants with severe major depressive disorder (MDD \[marked depression appearing in the involution pe...
Detailed Description
This is a single-arm (clinical study in only one group of participants), open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team...
Eligibility Criteria
Inclusion
- Participants diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)
- Scores of greater than or equal to 30 on the Montgomery-Asberg Depression Rating Scale (MADRS)
Exclusion
- Pregnant or lactating female participants
- Participants who are previously or currently diagnosed with the following mental disorders by DSM-IV: organic mental disorder, schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizoaffective disorder, delusional disorder, undifferentiated mental disorders and bipolar affective disorder, participants with history of drug abuse, including alcohol and drug abuse in the past 12 months
- Participants who have significant risk of suicide on clinical assessment (has a score of greater than or equal to 5 on item 5 of MADRS) or have made a serious suicide attempt within the past 6 months and have any contraindication to escitalopram
- Participants who have known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease currently taking other psychotropic drugs and anticonvulsant agents or continuously taking benzodiazepines or sleeping pills for over five days in the past one week
- Participants who have history of seizure (sudden, uncontrolled muscle spasms and loss of consciousness resulting from abnormal brain function) disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative diseases, parkinson disease and any movement disorders) and have multiple drug adverse reactions
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
225 Patients enrolled
Trial Details
Trial ID
NCT01814085
Start Date
February 1 2010
End Date
March 1 2012
Last Update
January 3 2014
Active Locations (6)
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1
Beijing, China
2
Huzhou, China
3
Nanjing, China
4
Qingdao, China