Clinical trial NCT01814085: A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression
Official title: A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Escitalopram
Lexapro
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Remission Based on Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Week 8
Secondary outcomes:
measure: Percentage of Participants With Clinical Response Based on Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and Week 8
measure: Percentage of Participants With Clinical Onset Based on Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Baseline and Week 8
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 1, 2, 4 and 8
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Change From Baseline in Hamilton Depression Rating Scale (HAM-D-17) Score at Week 1, 2, 4 and 8
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Change From Baseline in Hamilton Anxiety Scale (HAMA) Score at Week 1, 2, 4 and 8
timeFrame: Baseline, Week 1, 2, 4 and 8
measure: Change From Baseline in Brain-Derived Neurotrophic Factor (BDNF) at Week 8
timeFrame: Baseline and Week 8
measure: Change From Baseline in Short Form-12 (SF-12) Score at Week 8
timeFrame: Baseline and Week 8
measure: Change from Baseline in Plasma Drug Concentration at Week 1 and 8
timeFrame: Baseline, Week 1 and 8
measure: Number of Participants with Structural and Functional Changes in Magnetic Resonance Imaging (MRI) at Week 8
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Beijing
country: China
city: Huzhou
country: China
city: Nanjing
country: China
city: Qingdao
country: China
city: Shanghai
country: China
city: Wuhan
country: China
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: