Lexapro®'s Efficacy After Dose Escalation in Remission Study (LEADERS)

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: escitalopram

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01594866

AYM-LEADERS

Details and patient eligibility

About

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

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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