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

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ClinicalTrials.gov Identifier: NCT01594866
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE May 7, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date September 7, 2018
Study Start Date  ICMJE May 2012
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01594866 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Hamilton Depression Rating Scale-17 items (HAM-D) [ Time Frame: 6 weeks ]
  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 6 weeks ]
  • Clinical Global Impression-severity (CGI-S) [ Time Frame: 6 weeks ]
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 6 weeks ]
  • Beck's Depression Inventory(BDI) [ Time Frame: 6 weeks ]
  • WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF) [ Time Frame: 6 weeks ]
  • Clinically Useful Depression Outcome Scale (CUDOS) [ Time Frame: 6 weeks ]
  • Short From-36 Health survey (SF-36 Health survey) [ Time Frame: 6 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lexapro®'s Efficacy After Dose Escalation in Remission Study
Official Title  ICMJE 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
Brief 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.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: escitalopram
    escitalopram 20mg and 30mg p.o. daily, 6 weeks
    Other Name: Lexapro®
  • Drug: escitalopram
    escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups
    Other Name: Lexapro®
Study Arms  ICMJE
  • Placebo Comparator: Escitalopram, 20mg, placebo
    escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)
    Interventions:
    • Drug: escitalopram
    • Drug: escitalopram
  • Experimental: Escitalopram 20mg, escitalopram 10mg
    Escitalopram 20mg + Escitalopram 10mg
    Interventions:
    • Drug: escitalopram
    • Drug: escitalopram
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594866
Other Study ID Numbers  ICMJE AYM-LEADERS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yong Min Ahn, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE H. Lundbeck A/S
Investigators  ICMJE
Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP