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Completed

NCT Number: NCT01594866

Lexapro®'s Efficacy After Dose Escalation in Remission Study

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Escitalopram

Drug

escitalopram 20mg and 30mg p.o. daily, 6 weeks

Other names: Lexapro®

Primary outcomes

  1. Montgomery-Åsberg Depression Rating Scale (MADRS)

    Time frame: 6 weeks

Secondary outcomes

  1. Hamilton Depression Rating Scale-17 items (HAM-D)

    Time frame: 6 weeks

  2. Hamilton Anxiety Rating Scale (HAM-A)

    Time frame: 6 weeks

  3. Clinical Global Impression-severity (CGI-S)

    Time frame: 6 weeks

  4. Clinical Global Impression-Improvement (CGI-I)

    Time frame: 6 weeks

  5. Beck's Depression Inventory(BDI)

    Time frame: 6 weeks

  6. WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)

    Time frame: 6 weeks

  7. Clinically Useful Depression Outcome Scale (CUDOS)

    Time frame: 6 weeks

  8. Short From-36 Health survey (SF-36 Health survey)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • H. Lundbeck A/S

Registry information

Official study 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

Acronym: LEADERS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 9, 2012
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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