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HealthyNCT00001413

Bone Mineral Density in Women With Major Depression

An observational study of Healthy and Involutional Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to examine calcium absorption and bone mineral density in women with depression. Research indicates that pre-menopausal women with depression have significantly lower bone mineral density (BMD) than pre-menopausal women without depression. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy, Involutional Depression, Osteoporosis
How many people
585 participants
Where
1 siteUnited States
Study dates
6 Apr 1994to 19 Jan 2007
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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:
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Bone Mineral Density in Patients With Major Depression With Melancholic and Atypical Features: Relation to Stress-System Neurohormonal Function

The purpose of this study is to examine calcium absorption and bone mineral density in women with depression.

Research indicates that pre-menopausal women with depression have significantly lower bone mineral density (BMD) than pre-menopausal women without depression. Although the mechanisms of BMD loss are unclear, researchers believe that individuals with depression have impaired calcium absorption. However, it is unknown whether the abnormal absorption is a result of depression or a side effect of the drugs used to treat it. This study will compare calcium absorption in women with depression and in healthy women without depression.

Participants in this study will be given two non-radioactive calcium isotopes. One can be taken by mouth and the other must be injected. Participants will have the level of isotopes in their urine measured to estimate true fractional calcium absorption (TFCA). Participants may also have a dual X-ray absorptiometry (DEXA) scan to measure total body adiposity and lean body mass.

Read the detailed 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 controls. The difference was significant at several trabecular bone sites (e.g., 13.6% at the femoral neck, 13.6% at the Ward's triangle, and 10.8% at the trochanter). Epidemiological studies indicate that losses in trabecular bone mineral density of these magnitudes are associated with an increased lifetime risk for fracture up to 50%.

Although the mechanism(s) of the lower bone mineral density in our patients with past or current depression has not yet been elucidated, these subjects showed significantly higher 24-hour urinary free cortisol excretion than their matched controls. However, the extent of the lower bone mineral density in women with past or current depression cannot be accounted for strictly on the basis of hypercortisolism alone, but is likely to require other hormonal or biochemical factors as well.

Preliminary data in subjects recruited from a large study of mothers with or without mood disorders and their offspring indicate that a disproportionate number of young adult offspring of mothers with Major Depressive Disorder show reduced BMD, 2/3 of whom had not yet manifested clinical signs or symptoms of mood disorder.

In the light of the fact that major depression affects between 5% and 9% of the female population, the depression-associated lower bone mineral density potentially predisposes millions of women to enhanced susceptibility to osteoporosis. We therefore wish to continue our assessment of bone mineral density in subjects with past or current depression to further document the incidence of lower bone mineral density in a larger series. We also wish to identify subjects with past or present depression who have reduced bone mineral density to offer them the possibility of participating in other studies designed to clarify pathophysiologic mechanisms involved in low bone mineral density, identify any clinical characteristics of depressive illness that may predict increased risk of osteopenia or osteoporosis, examine the association of low BMD with other endocrine and metabolic disturbances seen in depressive illness, and to identify those who may require therapeutic intervention.

Keywords
Corticosteroids, Osteoporosis, Depression, DEXA Scan, Body Mass, Dual X-Ray, Energy Absorptiometry, Normal Volunteer
Medical subject headings
Depressive Disorder, Major, Osteoporosis, Depression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 1999 (estimated)
  2. Study start6 Apr 1994
  3. Study completion19 Jan 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
585 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00001413
Sponsor's protocol ID
940121
Other IDs
94-M-0121
Status last verified
19 Jan 2007
First submitted
3 Nov 1999
Last updated
2 Jul 2017
Results posted
No

Publications

  • Mazess RB, Barden H, Ettinger M, Schultz E. Bone density of the radius, spine, and proximal femur in osteoporosis. J Bone Miner Res. 1988 Feb;3(1):13-8. doi: 10.1002/jbmr.5650030104.

    PubMed 3213603

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Involutional Depression, run by National Institute of Mental Health (NIMH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00001413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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