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Trial record 1 of 1 for:    "Bone Mineral Density Quantitative Trait Locus 7" | "Antidepressive Agents"
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Antidepressants and Bone Mineral Density

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ClinicalTrials.gov Identifier: NCT02179268
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : July 1, 2014
Sponsor:
Information provided by (Responsible Party):
Yiming Wang, Guiyang Medical University

Tracking Information
First Submitted Date  ICMJE June 19, 2014
First Posted Date  ICMJE July 1, 2014
Last Update Posted Date July 1, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2014)
bone mineral density (BMD) [ Time Frame: Change from Baseline in bone mineral density at one year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antidepressants and Bone Mineral Density
Official Title  ICMJE International Committee of Medical Journal Editors
Brief Summary 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 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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Bone Mineral Density Quantitative Trait Locus 7
Intervention  ICMJE
  • Drug: sertraline
    50mg, 50-150mg/d,qd for one year
    Other Name: Zoloff
  • Drug: citalopram
    20mg, 20-40mg/d,qd,for one year
    Other Name: Cipramil
  • Drug: venlafaxine
    venlafaxine,25mg, 75-100mg/d, bid, for one year
    Other Name: Effexor
  • Drug: reboxetine
    reboxetine,4mg, 4-8mg/d,qd for one year
    Other Name: Edronax
  • Behavioral: control
    50min, every week for three months, every month, for nine months
    Other Name: cognitive behavioral therapy
Study Arms  ICMJE
  • 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).
    Interventions:
    • Drug: sertraline
    • Drug: citalopram
    • Drug: venlafaxine
    • Drug: reboxetine
    • Behavioral: control
  • 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).
    Interventions:
    • Drug: sertraline
    • Drug: citalopram
    • Drug: venlafaxine
    • Drug: reboxetine
    • Behavioral: control
  • 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).
    Interventions:
    • Drug: sertraline
    • Drug: citalopram
    • Drug: venlafaxine
    • Drug: reboxetine
    • Behavioral: control
  • 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).
    Interventions:
    • Drug: sertraline
    • Drug: citalopram
    • Drug: venlafaxine
    • Drug: reboxetine
    • Behavioral: control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 28, 2014)
203
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 48 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02179268
Other Study ID Numbers  ICMJE [2012] NO31260237/C090103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yiming Wang, Guiyang Medical University
Study Sponsor  ICMJE Guiyang Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: yiming wang, Ph.D World Health Organization
PRS Account Guiyang Medical University
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP