A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
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: Major Depressive Disorder
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 escitalopram treatment
in participants with severe major depressive disorder (MDD [marked depression appearing in
the involution period and characterized by hallucinations, delusions, paranoia, and
agitation]).
Clinical Details
Official title: A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression
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 Based on Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcome: Percentage of Participants With Clinical Response Based on Montgomery-Asberg Depression Rating Scale (MADRS)Percentage of Participants With Clinical Onset Based on Montgomery-Asberg Depression Rating Scale (MADRS) Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 1, 2, 4 and 8 Change From Baseline in Hamilton Depression Rating Scale (HAM-D-17) Score at Week 1, 2, 4 and 8 Change From Baseline in Hamilton Anxiety Scale (HAMA) Score at Week 1, 2, 4 and 8 Change From Baseline in Brain-Derived Neurotrophic Factor (BDNF) at Week 8 Change From Baseline in Short Form-12 (SF-12) Score at Week 8 Change from Baseline in Plasma Drug Concentration at Week 1 and 8 Number of Participants with Structural and Functional Changes in Magnetic Resonance Imaging (MRI) at Week 8
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 work on a medical research study), and prospective (study following
participants forward in time) study. The study consists of 2 parts: Screening (that is, 5
days before study commences on Day 1) and Treatment (that is, Week 1-8). All the eligible
participants will be receiving flexible doses of escitalopram orally in the dose range of 10
to 20 milligram per day (mg/day) for 8 weeks. Efficacy will primarily be evaluated by
remission rate at the end of the study. Participants' safety will be monitored throughout
the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Beijing, China
Huzhou, China
Nanjing, China
Qingdao, China
Shanghai, China
Wuhan, China
Additional Information
A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression
Starting date: February 2010
Last updated: January 2, 2014
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