Search / Trial NCT00001413

Bone Mineral Density in Women With Major Depression

Launched by NATIONAL INSTITUTE OF MENTAL HEALTH (NIMH) · Nov 3, 1999

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Trial Information

Current as of February 21, 2024

Completed

Keywords

Corticosteroids Osteoporosis Depression Dexa Scan Body Mass Dual X Ray Energy Absorptiometry Normal Volunteer

Description

Osteoporosis is a condition that is underdiagnosed and undertreated, and often goes unnoticed until a fragility fracture occurs after many years of progressive loss of bone quality. Risk factors for osteoporosis include glucocorticoid excess and a pro-inflammatory state, both of which we and others have observed in a substantial proportion of patients with Major Depressive Disorder. We have found statistically and clinically significant reductions in bone mineral density (BMD) in a group of 24 depressed but otherwise healthy pre-menopausal women, as compared to 24 healthy, closely matched ...

Gender

All

Eligibility criteria

  • -
  • INCLUSION CRITERIA:
  • A history of current or past major depression of at least four months duration, or a history of two or more brief depressive episodes will be the primary criterion for inclusion.
  • Patients with Bipolar Disorder will be eligible if they meet the depressive episode criterion.
  • No specific inclusion criteria are set for normal volunteers.
  • EXCLUSION CRITERIA:
  • DEPRESSED SUBJECTS:
  • Pregnant women will not be eligible to participate.
  • Known medical causes of osteoporosis, other than depression.
  • Current or past history of eating disorders, or schizophrenia, as per DSM-IV.
  • Chronic use of oral or parenteral steroids (daily use for 3 months or longer).
  • HEALTHY SUBJECTS:
  • Pregnant women will not be eligible to participate.
  • Known medical causes of osteoporosis.
  • Any history of DSM-IV diagnosis, including depression, eating disorders, and alcohol or drug abuse.
  • History or current evidence of any significant clinical or laboratory abnormalities.

Attachments

readout_NCT00001413_2024-02-21.pdf

4.5 MB

NCT00001413_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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