Lexapro®'s Efficacy After Dose Escalation in Remission Study

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: H. Lundbeck A/S
• Treatments: Citalopram; Dexetimide

Criteria

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