Skip to main content
OpenTrials
Completed

NCT Number: NCT02179268

Antidepressants and Bone Mineral Density

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–48 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sertraline

Drug

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

Other names: Zoloff

Citalopram

Drug

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

Other names: Cipramil

Venlafaxine

Drug

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

Other names: Effexor

reboxetine

Drug

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

Other names: Edronax

Control

Behavioral

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

Other names: cognitive behavioral therapy

Primary outcomes

  1. bone mineral density (BMD)

    Time frame: Change from Baseline in bone mineral density at one year

Sponsors and collaborators

Lead sponsor

Guiyang Medical University

Other

Registry information

Official study title

International Committee of Medical Journal Editors

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 1, 2014
Registry last updated
Jul 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.