Bone Mineral Density in Women With Major Depression (NCT00001413) | Clinical Trial Compass
CompletedNot Applicable
Bone Mineral Density in Women With Major Depression
United States585 participantsStarted 1994-04-06
Plain-language 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. 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.