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Antidepressants and Bone Mineral Density

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ClinicalTrials.gov Identifier: NCT02179268
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Yiming Wang, Guiyang Medical University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bone Mineral Density Quantitative Trait Locus 7 Drug: sertraline Drug: citalopram Drug: venlafaxine Drug: reboxetine Behavioral: control Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: International Committee of Medical Journal Editors
Study Start Date : March 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: sertraline & control
sertraline 50-150mg tables for 1 year,Control (cognitive behavioral therapy by psychiatrists, 50min, every week for three months, every month, for nine months).
Drug: sertraline
50mg, 50-150mg/d,qd for one year
Other Name: Zoloff

Drug: citalopram
20mg, 20-40mg/d,qd,for one year
Other Name: Cipramil

Drug: venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
Other Name: Effexor

Drug: reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year
Other Name: Edronax

Behavioral: control
50min, every week for three months, every month, for nine months
Other Name: cognitive behavioral therapy

Active Comparator: citalopram & Control
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).
Drug: sertraline
50mg, 50-150mg/d,qd for one year
Other Name: Zoloff

Drug: citalopram
20mg, 20-40mg/d,qd,for one year
Other Name: Cipramil

Drug: venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
Other Name: Effexor

Drug: reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year
Other Name: Edronax

Behavioral: control
50min, every week for three months, every month, for nine months
Other Name: cognitive behavioral therapy

Active Comparator: venlafaxine & control
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).
Drug: sertraline
50mg, 50-150mg/d,qd for one year
Other Name: Zoloff

Drug: citalopram
20mg, 20-40mg/d,qd,for one year
Other Name: Cipramil

Drug: venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
Other Name: Effexor

Drug: reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year
Other Name: Edronax

Behavioral: control
50min, every week for three months, every month, for nine months
Other Name: cognitive behavioral therapy

Active Comparator: reboxetine & control
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).
Drug: sertraline
50mg, 50-150mg/d,qd for one year
Other Name: Zoloff

Drug: citalopram
20mg, 20-40mg/d,qd,for one year
Other Name: Cipramil

Drug: venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
Other Name: Effexor

Drug: reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year
Other Name: Edronax

Behavioral: control
50min, every week for three months, every month, for nine months
Other Name: cognitive behavioral therapy




Primary Outcome Measures :
  1. bone mineral density (BMD) [ Time Frame: Change from Baseline in bone mineral density at one year ]


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Ages Eligible for Study:   20 Years to 48 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants needed to have a primary diagnosis of depression with Zung Self Rated Depression Scale (SDS) > 53, and Hamilton Depression Scale (HAMD) ≥20.

Exclusion Criteria:

  • The patients with hyperparathyroidism, myeloma or other disorders known to affect bone metabolism
  • Use of estrogen
  • Calcitonin drugs
  • Previous antidepressant or other psychiatric drug use or prior treatment history

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): NCT02179268


Sponsors and Collaborators
Guiyang Medical University
Investigators
Study Chair: yiming wang, Ph.D World Health Organization

Responsible Party: Yiming Wang, Department of Psychiatry, the Affiliated Hospital, Guiyang Medical University
ClinicalTrials.gov Identifier: NCT02179268     History of Changes
Other Study ID Numbers: [2012] NO31260237/C090103
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: July 1, 2014
Last Verified: June 2014

Keywords provided by Yiming Wang, Guiyang Medical University:
Antidepressants
bone mineral density
bone turnover markers

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Antidepressive Agents
Sertraline
Venlafaxine Hydrochloride
Citalopram
Reboxetine
Dexetimide
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Adrenergic Uptake Inhibitors