Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT01594866
Status:
COMPLETED
Last Update Posted:
2018-09-07
First Post:
2012-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lexapro®'s Efficacy After Dose Escalation in Remission Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000089983', 'term': 'Escitalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2012-05-07', 'studyFirstSubmitQcDate': '2012-05-08', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Montgomery-Åsberg Depression Rating Scale (MADRS)', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Hamilton Depression Rating Scale-17 items (HAM-D)', 'timeFrame': '6 weeks'}, {'measure': 'Hamilton Anxiety Rating Scale (HAM-A)', 'timeFrame': '6 weeks'}, {'measure': 'Clinical Global Impression-severity (CGI-S)', 'timeFrame': '6 weeks'}, {'measure': 'Clinical Global Impression-Improvement (CGI-I)', 'timeFrame': '6 weeks'}, {'measure': "Beck's Depression Inventory(BDI)", 'timeFrame': '6 weeks'}, {'measure': 'WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)', 'timeFrame': '6 weeks'}, {'measure': 'Clinically Useful Depression Outcome Scale (CUDOS)', 'timeFrame': '6 weeks'}, {'measure': 'Short From-36 Health survey (SF-36 Health survey)', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Major depressive disorder, remission, escitalopram'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18 \\~ 65\n* Patient with major depressive disorder according to DSM-IV criteria\n* Patient have signed on the informed consent, and well understood the objective and procedure of this study.\n* MADRS total score ≥ 18\n* Competent patient who is manage to answer the questionnaires.\n* 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.\n\nExclusion Criteria:\n\n* In previous depressive episodes, no efficacy although more than one antidepressant treatment\n* Allergy or hypersensitivity to escitalopram\n* Diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (DSM-IV)\n* 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\n* Pregnant or breast-feeding female patient\n* Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion\n* Significant severe medical condition\n* Patients who take antipsychotics or mood stabilizer or other psychiatric drugs excluding benzodiazepines or beta blockers or hypnotics\n* History of participating to other investigational drug trial within 1month prior to screening\n* 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"}, 'identificationModule': {'nctId': 'NCT01594866', 'acronym': 'LEADERS', 'briefTitle': "Lexapro®'s Efficacy After Dose Escalation in Remission Study", 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AYM-LEADERS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Escitalopram, 20mg, placebo', 'description': 'escitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)', 'interventionNames': ['Drug: escitalopram']}, {'type': 'EXPERIMENTAL', 'label': 'Escitalopram 20mg, escitalopram 10mg', 'description': 'Escitalopram 20mg + Escitalopram 10mg', 'interventionNames': ['Drug: escitalopram']}], 'interventions': [{'name': 'escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro®'], 'description': 'escitalopram 20mg and 30mg p.o. daily, 6 weeks', 'armGroupLabels': ['Escitalopram 20mg, escitalopram 10mg', 'Escitalopram, 20mg, placebo']}, {'name': 'escitalopram', 'type': 'DRUG', 'otherNames': ['Lexapro®'], 'description': 'escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups', 'armGroupLabels': ['Escitalopram 20mg, escitalopram 10mg', 'Escitalopram, 20mg, placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Yong Min Ahn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Yong Min Ahn', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}