A Phase 3 interventional study of sertraline and citalopram in Bone Mineral Density Quantitative Trait Locus 7, sponsored by Guiyang Medical University. Completed. Open to participants aged 20 Years to 48 Years. Per ClinicalTrials.gov, last updated 2014-07-01.
Sponsored by Guiyang Medical University · Phase 3, Interventional, and Supportive care
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.
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.
Guiyang Medical University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Drug: citalopram · Drug: venlafaxine · Drug: reboxetine · Behavioral: 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 · Drug: citalopram · Drug: venlafaxine · Drug: reboxetine · Behavioral: 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 · Drug: citalopram · Drug: venlafaxine · Drug: reboxetine · Behavioral: 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 · Drug: citalopram · Drug: venlafaxine · Drug: reboxetine · Behavioral: control
50mg, 50-150mg/d,qd for one year
Also known as: Zoloff
20mg, 20-40mg/d,qd,for one year
Also known as: Cipramil
venlafaxine,25mg, 75-100mg/d, bid, for one year
Also known as: Effexor
reboxetine,4mg, 4-8mg/d,qd for one year
Also known as: Edronax
50min, every week for three months, every month, for nine months
Also known as: cognitive behavioral therapy
bone mineral density (BMD)
Time frame: Change from Baseline in bone mineral density at one year
No study locations are listed for this record.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Guiyang Medical University