A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression
Overview
- Phase
- Phase 4
- Intervention
- Escitalopram
- Conditions
- Major Depressive Disorder
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Enrollment
- 225
- Primary Endpoint
- Percentage of Participants With Remission Based on Montgomery-Asberg Depression Rating Scale (MADRS)
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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 period and characterized by hallucinations, delusions, paranoia, and agitation]).
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.
Investigators
Eligibility 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
Arms & Interventions
Escitalopram
Escitalopram tablets will be administered orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Dose can be adjusted as per Investigator's discretion depending on participant's response.
Intervention: Escitalopram
Outcomes
Primary Outcomes
Percentage of Participants With Remission Based on Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: Week 8
Remission is defined as percentage of participants with MADRS total score less than or equal to10 at the endpoint (8 weeks). The MADRS is a scale designed to measure depression severity and detects changes due to antidepressant treatment. The test consists of 10 items, each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total score of 60. Higher score represents a more severe condition.
Secondary Outcomes
- Percentage of Participants With Clinical Response Based on Montgomery-Asberg Depression Rating Scale (MADRS)(Baseline and Week 8)
- Change From Baseline in Hamilton Depression Rating Scale (HAM-D-17) Score at Week 1, 2, 4 and 8(Baseline, Week 1, 2, 4 and 8)
- Percentage of Participants With Clinical Onset Based on Montgomery-Asberg Depression Rating Scale (MADRS)(Baseline and Week 8)
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 1, 2, 4 and 8(Baseline, Week 1, 2, 4 and 8)
- Number of Participants with Structural and Functional Changes in Magnetic Resonance Imaging (MRI) at Week 8(Baseline and Week 8)
- Change From Baseline in Hamilton Anxiety Scale (HAMA) Score at Week 1, 2, 4 and 8(Baseline, Week 1, 2, 4 and 8)
- Change From Baseline in Brain-Derived Neurotrophic Factor (BDNF) at Week 8(Baseline and Week 8)
- Change From Baseline in Short Form-12 (SF-12) Score at Week 8(Baseline and Week 8)
- Change from Baseline in Plasma Drug Concentration at Week 1 and 8(Baseline, Week 1 and 8)