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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Seoul National University Hospital
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Yong Min Ahn, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01594866
First received: May 7, 2012
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Major Depressive Disorder
Drug: escitalopram
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Depression Rating Scale-17 items (HAM-D) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-severity (CGI-S) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Improvement (CGI-I) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Beck's Depression Inventory(BDI) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Clinically Useful Depression Outcome Scale (CUDOS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Short From-36 Health survey (SF-36 Health survey) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Escitalopram, 20mg, placebo
escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)
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®
Experimental: Escitalopram 20mg, escitalopram 10mg
Escitalopram 20mg + Escitalopram 10mg
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®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594866

Contacts
Contact: Eun Young Kim, MD 82 2 2072 2457 npeunyoung@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Yong Min Ahn, MD, PhD         
Sponsors and Collaborators
Seoul National University Hospital
H. Lundbeck A/S
Investigators
Principal Investigator: Yong Min Ahn, MD, PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yong Min Ahn, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01594866     History of Changes
Other Study ID Numbers: AYM-LEADERS
Study First Received: May 7, 2012
Last Updated: December 5, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
Major depressive disorder, remission, escitalopram

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on August 28, 2014