Antidepressants and Bone Mineral Density

June 28, 2014 updated by: Yiming Wang, Guiyang Medical University

International Committee of Medical Journal Editors

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

203

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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 Names:
  • Zoloff
Drug: citalopram
20mg, 20-40mg/d,qd,for one year
Other Names:
  • Cipramil
Drug: venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
Other Names:
  • Effexor
Drug: reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year
Other Names:
  • Edronax
Behavioral: control
50min, every week for three months, every month, for nine months
Other Names:
  • 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 Names:
  • Zoloff
Drug: citalopram
20mg, 20-40mg/d,qd,for one year
Other Names:
  • Cipramil
Drug: venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
Other Names:
  • Effexor
Drug: reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year
Other Names:
  • Edronax
Behavioral: control
50min, every week for three months, every month, for nine months
Other Names:
  • 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 Names:
  • Zoloff
Drug: citalopram
20mg, 20-40mg/d,qd,for one year
Other Names:
  • Cipramil
Drug: venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
Other Names:
  • Effexor
Drug: reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year
Other Names:
  • Edronax
Behavioral: control
50min, every week for three months, every month, for nine months
Other Names:
  • 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 Names:
  • Zoloff
Drug: citalopram
20mg, 20-40mg/d,qd,for one year
Other Names:
  • Cipramil
Drug: venlafaxine
venlafaxine,25mg, 75-100mg/d, bid, for one year
Other Names:
  • Effexor
Drug: reboxetine
reboxetine,4mg, 4-8mg/d,qd for one year
Other Names:
  • Edronax
Behavioral: control
50min, every week for three months, every month, for nine months
Other Names:
  • cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guiyang Medical University

Investigators

  • Study Chair: yiming wang, Ph.D, World Health Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 28, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

July 1, 2014

Last Update Submitted That Met QC Criteria

June 28, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • [2012] NO31260237/C090103

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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