A Safety and Efficacy Study of Escitalopram on Acute Treatment of Severe Depression

NCT01814085 | Completed Phase 4

• 2 other identifiers: CR016300ESCITALDEP4001
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 6

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 \[marked depression appearing in the involution period and characterized by hallucinations, delusions, paranoia, and agitation\]).

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Escitalopram; Lexapro

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Remission Based on Montgomery-Asberg Depression Rating Scale (MADRS)

  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.

  Week 8

Secondary Outcomes (9)

• Percentage of Participants With Clinical Response Based on Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline and Week 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

• 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

• Change From Baseline in Hamilton Anxiety Scale (HAMA) Score at Week 1, 2, 4 and 8

  Baseline, Week 1, 2, 4 and 8

Study Arms (1)

Escitalopram

EXPERIMENTAL

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.

Drug: Escitalopram

Interventions

Escitalopram DRUG

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.

Also known as: Lexapro

Escitalopram

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants diagnosed with major depressive disorder (MDD) according to Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)

You may not qualify if:

• 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

Sponsors & Collaborators

• Xian-Janssen Pharmaceutical Ltd.: lead

Study Sites (6)

Unknown Facility

Beijing, China

Location

Unknown Facility

Huzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Qingdao, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Wuhan, China

Location

Related Links

• A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

  Xian-Janssen Pharmaceutical Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 19, 2013
• Study Start: February 1, 2010
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: January 3, 2014

Record last verified: 2014-01

Locations

CN (6)