Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-24 @ 12:53 PM
Study NCT ID:
NCT01601002
Status:
COMPLETED
Last Update Posted:
2016-04-21
First Post:
2012-05-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression
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': 'D000078785', 'term': 'Mirtazapine'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-20', 'studyFirstSubmitDate': '2012-05-15', 'studyFirstSubmitQcDate': '2012-05-16', 'lastUpdatePostDateStruct': {'date': '2016-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'increase in weight as measured in the clinic', 'timeFrame': 'Weeks 1,2,4,8 and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of population achieving clinical response as measured by rate of fall in HAM-D 24 item scores', 'timeFrame': 'Start to end of study (12 weeks)'}, {'measure': 'Proportion of patients achieving remission at end of study on HAM-D 24 (<11)', 'timeFrame': 'Start to end of study (12 weeks)'}, {'measure': 'Frequency of adverse events', 'timeFrame': 'Start to end of study (12 weeks)'}, {'measure': 'Percentage adhering to medication', 'timeFrame': 'Start to end of study (12 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mirtazapine'], 'conditions': ['Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': 'Patients with an episode of depression in late life prescribed mirtazapine recruited from a clinical sample will be monitored for weight and receive a blood test during their usual course of treatment to determine polymorphisms in a specific gene (LEPR) thought to affect weight gain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients older than 50 years\n* meeting criteria for a diagnosis of major depressive disorder (DSM IV code 296.2x or 296.3x) as confirmed by a score \\> 20 on the HAM-D 24 items scale and a structured clinical interview using the SCID by a consultant psychiatrist\n\nExclusion Criteria:\n\n* Treatment resistant depression (as defined by failure to respond to ≥2 adequate antidepressant trials)\n* Major depressive disorder with psychosis (296.x4)\n* Those with depression who fulfill the chronic specifier (MDE for \\>2 years)\n* Significant Axis II pathology\n* Previous trial with mirtazapine\n* Concurrent antipsychotic usage\n* Comorbid dementia (as confirmed by MMSE \\< 24)\n* Substance misuse including drug and/or alcohol dependence/abuse in the past 3 months\n* Bipolar disorder\n* Schizophrenia\n* Obsessive compulsive disorder\n* Post traumatic stress disorder\n* Eating disorder\n* Head injury\n* Recent stroke (\\< 3 months)\n* Recent MI (\\< 3 months)\n* Currently actively participating in structured/formal psychotherapy\n* Being non ambulatory\n* Those actively suicidal\n* Those incapable of informed consent'}, 'identificationModule': {'nctId': 'NCT01601002', 'briefTitle': 'LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Does LEPR Polymorphism Predict Variability in Weight Gain Induced by Mirtazapine in the Treatment of Late Life Depression?', 'orgStudyIdInfo': {'id': 'HSREB-102574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mirtazapine', 'description': 'Mirtazapine in dosage of 7.5 mg to 45 mg/day', 'interventionNames': ['Drug: Mirtazapine']}], 'interventions': [{'name': 'Mirtazapine', 'type': 'DRUG', 'otherNames': ['Remeron'], 'description': 'Mirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label', 'armGroupLabels': ['Mirtazapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Akshya Vasudev, MBBS, MD, MRCPsych', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Akshya Vasudev', 'investigatorAffiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}}}}