Lexapro®'s Efficacy After Dose Escalation in Remission Study

Major Depressive Disorder Clinical Trial

— LEADERS  

Official title:

A Double-blinded 6-week Prospective Study to Evaluate the Remission Rate According to Dose of Escitalopram (Lexapro®) in Patients With Major Depressive Disorder: a Preliminary Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594866
• Other study ID #: AYM-LEADERS
• Status: Completed
• Phase: Phase 4
• Start date: May 2012
• Est. completion date: December 2016

Study information

• Verified date: September 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.

Description:

In this study, the investigators are going to examine the efficacy of escitalopram after dose escalation and evaluate remission rate. This study design is the double-blinded 6-week prospective study. It would be useful for clinicians because there were few study of high-dose antidepressant treatment in lack of remission in major depressive disorder patients. To control of bias, the investigators included patients with lack of remission after 4-week escitalopram treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age: 18 ~ 65

• Patient with major depressive disorder according to DSM-IV criteria

• Patient have signed on the informed consent, and well understood the objective and procedure of this study.

• MADRS total score = 18

• Competent patient who is manage to answer the questionnaires.

• In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

• In previous depressive episodes, no efficacy although more than one antidepressant treatment

• Allergy or hypersensitivity to escitalopram

• Diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (DSM-IV)

• MADRS 10 score = 5, or patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion

• Pregnant or breast-feeding female patient

• Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion

• Significant severe medical condition

• Patients who take antipsychotics or mood stabilizer or other psychiatric drugs excluding benzodiazepines or beta blockers or hypnotics

• History of participating to other investigational drug trial within 1month prior to screening

• Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• escitalopram
escitalopram 20mg and 30mg p.o. daily, 6 weeks
• escitalopram
escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	H. Lundbeck A/S

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS)		6 weeks
Secondary	Hamilton Depression Rating Scale-17 items (HAM-D)		6 weeks
Secondary	Hamilton Anxiety Rating Scale (HAM-A)		6 weeks
Secondary	Clinical Global Impression-severity (CGI-S)		6 weeks
Secondary	Clinical Global Impression-Improvement (CGI-I)		6 weeks
Secondary	Beck's Depression Inventory(BDI)		6 weeks
Secondary	WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)		6 weeks
Secondary	Clinically Useful Depression Outcome Scale (CUDOS)		6 weeks
Secondary	Short From-36 Health survey (SF-36 Health survey)		6 weeks