Antidepressants and Bone Mineral Density

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-04-30

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.

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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.

Conditions

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Bone Mineral Density Quantitative Trait Locus 7

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

sertraline

Intervention Type DRUG

50mg, 50-150mg/d,qd for one year

citalopram

Intervention Type DRUG

20mg, 20-40mg/d,qd,for one year

venlafaxine

Intervention Type DRUG

venlafaxine,25mg, 75-100mg/d, bid, for one year

reboxetine

Intervention Type DRUG

reboxetine,4mg, 4-8mg/d,qd for one year

control

Intervention Type BEHAVIORAL

50min, every week for three months, every month, for nine months

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).

Group Type ACTIVE_COMPARATOR

sertraline

Intervention Type DRUG

50mg, 50-150mg/d,qd for one year

citalopram

Intervention Type DRUG

20mg, 20-40mg/d,qd,for one year

venlafaxine

Intervention Type DRUG

venlafaxine,25mg, 75-100mg/d, bid, for one year

reboxetine

Intervention Type DRUG

reboxetine,4mg, 4-8mg/d,qd for one year

control

Intervention Type BEHAVIORAL

50min, every week for three months, every month, for nine months

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).

Group Type ACTIVE_COMPARATOR

sertraline

Intervention Type DRUG

50mg, 50-150mg/d,qd for one year

citalopram

Intervention Type DRUG

20mg, 20-40mg/d,qd,for one year

venlafaxine

Intervention Type DRUG

venlafaxine,25mg, 75-100mg/d, bid, for one year

reboxetine

Intervention Type DRUG

reboxetine,4mg, 4-8mg/d,qd for one year

control

Intervention Type BEHAVIORAL

50min, every week for three months, every month, for nine months

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).

Group Type ACTIVE_COMPARATOR

sertraline

Intervention Type DRUG

50mg, 50-150mg/d,qd for one year

citalopram

Intervention Type DRUG

20mg, 20-40mg/d,qd,for one year

venlafaxine

Intervention Type DRUG

venlafaxine,25mg, 75-100mg/d, bid, for one year

reboxetine

Intervention Type DRUG

reboxetine,4mg, 4-8mg/d,qd for one year

control

Intervention Type BEHAVIORAL

50min, every week for three months, every month, for nine months

Interventions

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sertraline

50mg, 50-150mg/d,qd for one year

Intervention Type DRUG

citalopram

20mg, 20-40mg/d,qd,for one year

Intervention Type DRUG

venlafaxine

venlafaxine,25mg, 75-100mg/d, bid, for one year

Intervention Type DRUG

reboxetine

reboxetine,4mg, 4-8mg/d,qd for one year

Intervention Type DRUG

control

50min, every week for three months, every month, for nine months

Intervention Type BEHAVIORAL

Other Intervention Names

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Zoloff Cipramil Effexor Edronax cognitive behavioral therapy

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No