Antidepressants and Bone Mineral Density

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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International Committee of Medical Journal Editors

Conditions
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Bone Mineral Density Quantitative Trait Locus 7

Intervention / Treatment
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* Drug: sertraline
* Drug: citalopram
* Drug: venlafaxine
* Drug: reboxetine
* Behavioral: control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 48 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sertraline & control<br>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<br>* 50mg, 50-150mg/d,qd for one year<br>* Other names: Zoloff;Drug: citalopram<br>* 20mg, 20-40mg/d,qd,for one year<br>* Other names: Cipramil;Drug: venlafaxine<br>* venlafaxine,25mg, 75-100mg/d, bid, for one year<br>* Other names: Effexor;Drug: reboxetine<br>* reboxetine,4mg, 4-8mg/d,qd for one year<br>* Other names: Edronax;Behavioral: control<br>* 50min, every week for three months, every month, for nine months<br>* Other names: cognitive behavioral therapy;|
| Active Comparator: citalopram & Control<br>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<br>* 50mg, 50-150mg/d,qd for one year<br>* Other names: Zoloff;Drug: citalopram<br>* 20mg, 20-40mg/d,qd,for one year<br>* Other names: Cipramil;Drug: venlafaxine<br>* venlafaxine,25mg, 75-100mg/d, bid, for one year<br>* Other names: Effexor;Drug: reboxetine<br>* reboxetine,4mg, 4-8mg/d,qd for one year<br>* Other names: Edronax;Behavioral: control<br>* 50min, every week for three months, every month, for nine months<br>* Other names: cognitive behavioral therapy;|
| Active Comparator: venlafaxine & control<br>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<br>* 50mg, 50-150mg/d,qd for one year<br>* Other names: Zoloff;Drug: citalopram<br>* 20mg, 20-40mg/d,qd,for one year<br>* Other names: Cipramil;Drug: venlafaxine<br>* venlafaxine,25mg, 75-100mg/d, bid, for one year<br>* Other names: Effexor;Drug: reboxetine<br>* reboxetine,4mg, 4-8mg/d,qd for one year<br>* Other names: Edronax;Behavioral: control<br>* 50min, every week for three months, every month, for nine months<br>* Other names: cognitive behavioral therapy;|
| Active Comparator: reboxetine & control<br>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<br>* 50mg, 50-150mg/d,qd for one year<br>* Other names: Zoloff;Drug: citalopram<br>* 20mg, 20-40mg/d,qd,for one year<br>* Other names: Cipramil;Drug: venlafaxine<br>* venlafaxine,25mg, 75-100mg/d, bid, for one year<br>* Other names: Effexor;Drug: reboxetine<br>* reboxetine,4mg, 4-8mg/d,qd for one year<br>* Other names: Edronax;Behavioral: control<br>* 50min, every week for three months, every month, for nine months<br>* Other names: cognitive behavioral therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density (BMD) |  | Change from Baseline in bone mineral density at one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antidepressants, bone mineral density, bone turnover markers