Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02179268
Status:
COMPLETED
Last Update Posted:
2014-07-01
First Post:
2014-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antidepressants and Bone Mineral Density
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D015283', 'term': 'Citalopram'}, {'id': 'D003909', 'term': 'Dexetimide'}, {'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}, {'id': 'D000077593', 'term': 'Reboxetine'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011437', 'term': 'Propylamines'}, {'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'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-28', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-06-28', 'lastUpdatePostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bone mineral density (BMD)', 'timeFrame': 'Change from Baseline in bone mineral density at one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Antidepressants', 'bone mineral density', 'bone turnover markers'], 'conditions': ['Bone Mineral Density Quantitative Trait Locus 7']}, 'descriptionModule': {'briefSummary': 'The aim of this five arm randomized trial was thus to compare selective serotonin reuptake inhibitor (SSRI)sertraline and citalopram to a dual reuptake inhibitor venlafaxine, a nor-adrenaline reuptake inhibitor reboxetine and a control group receiving placebo, with the primary endpoint being bone mineral density, and secondary endpoints being bone turnover markers.', 'detailedDescription': 'These results have overt clinical implications. They suggest a noxious effect, particularly of selective serotonin reuptake inhibitor (SSRI) antidepressants, on bone. Osteoporosis and fracture is overtly the problem of the elderly. However, the process of skeletal consolidation begins in childhood and the corresponding phase of demineralisation proceeds at a glacial pace and lasts throughout adulthood, as a consequence antidepressant therapy is likely to have a substantive impact on a phenomenon likely to manifest decades hence. It is known that numerically small changes in bone mineral density are associated with a substantial increase in fracture risk. Because the SSRIs have only been in widespread use for two decades, it is plausible that the consequences of this adverse effect are yet to emerge. These data consequently suggest a recalibration of the risk/benefit ratio of this class of agents and additionally beg the question of the potential role of screening for bone mineral density in this at-risk population group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '48 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants needed to have a primary diagnosis of depression with Zung Self Rated Depression Scale (SDS) \\> 53, and Hamilton Depression Scale (HAMD) ≥20.\n\nExclusion Criteria:\n\n* The patients with hyperparathyroidism, myeloma or other disorders known to affect bone metabolism\n* Use of estrogen\n* Calcitonin drugs\n* Previous antidepressant or other psychiatric drug use or prior treatment history'}, 'identificationModule': {'nctId': 'NCT02179268', 'briefTitle': 'Antidepressants and Bone Mineral Density', 'organization': {'class': 'OTHER', 'fullName': 'Guiyang Medical University'}, 'officialTitle': 'International Committee of Medical Journal Editors', 'orgStudyIdInfo': {'id': '[2012] NO31260237/C090103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'sertraline & control', 'description': 'sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).', 'interventionNames': ['Drug: sertraline', 'Drug: citalopram', 'Drug: venlafaxine', 'Drug: reboxetine', 'Behavioral: control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'citalopram & Control', 'description': 'citalopram 20-40mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).', 'interventionNames': ['Drug: sertraline', 'Drug: citalopram', 'Drug: venlafaxine', 'Drug: reboxetine', 'Behavioral: control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'venlafaxine & control', 'description': 'venlafaxine 75-100mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).', 'interventionNames': ['Drug: sertraline', 'Drug: citalopram', 'Drug: venlafaxine', 'Drug: reboxetine', 'Behavioral: control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'reboxetine & control', 'description': 'reboxetine 4-8mg tables by mouth every day for 1 year, Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).', 'interventionNames': ['Drug: sertraline', 'Drug: citalopram', 'Drug: venlafaxine', 'Drug: reboxetine', 'Behavioral: control']}], 'interventions': [{'name': 'sertraline', 'type': 'DRUG', 'otherNames': ['Zoloff'], 'description': '50mg, 50-150mg/d,qd for one year', 'armGroupLabels': ['citalopram & Control', 'reboxetine & control', 'sertraline & control', 'venlafaxine & control']}, {'name': 'citalopram', 'type': 'DRUG', 'otherNames': ['Cipramil'], 'description': '20mg, 20-40mg/d,qd,for one year', 'armGroupLabels': ['citalopram & Control', 'reboxetine & control', 'sertraline & control', 'venlafaxine & control']}, {'name': 'venlafaxine', 'type': 'DRUG', 'otherNames': ['Effexor'], 'description': 'venlafaxine,25mg, 75-100mg/d, bid, for one year', 'armGroupLabels': ['citalopram & Control', 'reboxetine & control', 'sertraline & control', 'venlafaxine & control']}, {'name': 'reboxetine', 'type': 'DRUG', 'otherNames': ['Edronax'], 'description': 'reboxetine,4mg, 4-8mg/d,qd for one year', 'armGroupLabels': ['citalopram & Control', 'reboxetine & control', 'sertraline & control', 'venlafaxine & control']}, {'name': 'control', 'type': 'BEHAVIORAL', 'otherNames': ['cognitive behavioral therapy'], 'description': '50min, every week for three months, every month, for nine months', 'armGroupLabels': ['citalopram & Control', 'reboxetine & control', 'sertraline & control', 'venlafaxine & control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'yiming wang, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'World Health Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guiyang Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Psychiatry, the Affiliated Hospital', 'investigatorFullName': 'Yiming Wang', 'investigatorAffiliation': 'Guiyang Medical University'}}}}