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

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ClinicalTrials.gov Identifier: NCT01594866
Recruitment Status : Unknown
Verified December 2015 by Yong Min Ahn, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2012
Last Update Posted : December 8, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: escitalopram Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2012
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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®


Outcome Measures

Primary Outcome Measures :
  1. Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yong Min Ahn, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01594866     History of Changes
Other Study ID Numbers: AYM-LEADERS
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015

Keywords provided by Yong Min Ahn, 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
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents