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Adolescent DepressionNCT00399776

Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy

An observational study of Adolescent Depression, run by Creighton University 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

We hypothesize that antipsychotic induced hyperprolactinemia can decrease bone mineral accrual and decrease bone mineral content (BMC) in adolescents on antipsychotic therapy. Specifics Aims 1. Read more about this study

Who is it for?
Ages 10 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Adolescent Depression
What is being tested?
Bone Density Test
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteUnited States
Study dates
Oct 2006to Sep 2009
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 10 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Subjects will be recruited from within the clinic as well as community psychiatrists

Who may be able to join

  • Adolescent females and males with antipsychotic exposure equivalent to at least 100 chlorpromazine equivalents for a minimum of one year.
  • Age between 10 and 17 years of age
  • Within 10th and 90th percentile for height and weight -

Who cannot join

  • Pregnant
  • Chronic illness such as asthma, inflammatory bowel disease, rheumatoid disorders or cystic fibrosis.
  • On chronic systemic steroid therapy for the past 12 months
  • For subjects with hypothyroidism and on thyroid replacement therapy, TSH level will be obtained to determine eligibility.
  • Menstrual irregularities secondary to excessive physical activity.
  • History of anorexia nervosa and/or bulimia nervosa.
  • Subjects on hormonal contraception. -

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Creighton University Psychiatry Research Center

    Omaha, Nebraska, 68131

Other trials in United States

About this study

We hypothesize that antipsychotic induced hyperprolactinemia can decrease bone mineral accrual and decrease bone mineral content (BMC) in adolescents on antipsychotic therapy.

Specifics Aims

  1. To determine if antipsychotic therapy leads to decreased bone mineral accrual and decreased bone mineral content in a group of adolescents on antipsychotic therapy by comparing them to an ethnicity, gender and pubertal stage matched control group.
  2. To determine the relationship between serum concentrations of prolactin, sex steroids and bone turnover markers in adolescents on antipsychotic therapy and an ethnicity, gender and pubertal stage matched control group.
Read the detailed description

Recent studies have shown an increase in antipsychotic prescriptions among children and adolescents. Virtually all pediatric use of antipsychotics is "off-label," meaning without a Food and Drug Administration indication. To make matters worse, pediatric antipsychotic usage can lead to serious side effects like movement disorders and metabolic disturbances. Hence, it is concerning that despite the virtual absence of long term efficacy and safety data, the widespread use of antipsychotics in children and adolescents continues. One important adverse effects of antipsychotic therapy is hyperprolactinemia. Prolactin is a hormone secreted by the central nervous system. The main action of prolactin in females is the induction and maintenance of lactation. The main action of prolactin in females is the induction and maintenance of lactation. Antipsychotic therapy has shown to raise prolactin levels both, in the adult and pediatric population. Sustained hyperprolactinemia can cause a number of endocrinological abnormalities leading to a hypogonadal state and eventually bone demineralization and osteoporosis. There is evidence linking pediatric prolactinomas to decreased bone density. Also, adult studies suggest that the high rates of osteoporosis in schizophrenia may result from hypogonadism secondary to antipsychotic induced hyperprolactinemia. Our concern is that the sequela of antipsychotic induced hyperprolactinemia in children and adolescents, has received little attention, despite the important implications for bone health. This topic is especially important because peak bone mass is achieved during adolescence and is a key determinant of the lifetime risk of osteoporosis.

We hypothesize that antipsychotic induced hyperprolactinemia can interrupt bone mineral accrual and reduce bone mineral content in adolescents on antipsychotic therapy. We plan to measure bone mineral content and peripheral markers of bone metabolism in adolescents on antipsychotic therapy and compare them with ethnicity, gender and pubertal stage matched controls. We also plan to measure serum levels of prolactin and other hormonal measures such as: estradiol, progesterone, testosterone, follicle stimulating hormone, luteinizing hormone and thyroid function tests in both the groups. Statistical analysis will be performed to compare bone mineral content between the study and control groups. Additionally, the association between the hormonal measures and bone mineral content will be determined.

Osteoporosis is a major public health problem. In the United States today, 10 million individuals already have osteoporosis, and 18 million more have low bone mass, placing them at an increased risk for this disorder. Optimization of bone health is a process that must occur throughout the lifespan and factors that influence bone health at all ages are essential to prevent osteoporosis and its devastating consequences. To date, there are no published studies, examining the association between antipsychotic induced hyperprolactinemia and bone mineral content (BMC) and/or risk of osteoporosis in children or adolescents. Although there have been reports of antipsychotic induced hyperprolactinemia in both prepubertal and postpubertal children, it has been suggested that post pubertal children may be at a higher risk of decreased BMC. Thus, we plan to initially study the effects on adolescents. Potential implications of our research findings include: providing recommendations for preventing, diagnosing and monitoring bone mineral content/density during pediatric antipsychotic therapy. Since this is an unexplored area, yet very crucial field, findings from our study can be expected to have ramifications for clinical practice within one to two years of project completion.

Being tested
Bone Density Test
Keywords
bone mineral, antipsychotic therapy, bone mineral accrual, bone mineral content

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bone Density TestRadiation

    Evaluating bone mineral content and bone metabolism in adolescents on antipsychotic therapy compared to healthy adolescents

Study groups in NCT00399776
Study groupRoleWhat they receive
Group AAdolescents taking haloperidol, risperidone, or olanzapine
Receives: Radiation: Bone Density Test
Group BHealthy adolescents
Receives: Radiation: Bone Density Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Antipsychotic induced hyperprolactinemia can decrease bone mineral accrual

    Measured: This is a 2 visit study

Secondary outcomes (1)
  1. Determine relationship between serum concentrations of prolactin, sex steroids and bone turnover markers in adolescents on antipsychotic therapy

    Measured: This is a 2 visit study

Timeline

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

  1. First posted15 Nov 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionSep 2009
  4. Study completionSep 2009

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00399776
Sponsor's protocol ID
06-14216
Status last verified
Aug 2011
First submitted
13 Nov 2006
Last updated
4 Aug 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Adolescent Depression, run by Creighton University 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 7 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 4 Aug 2011. 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.

What does the primary outcome measure?

Antipsychotic induced hyperprolactinemia can decrease bone mineral accrual (time frame: This is a 2 visit study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 4 Aug 2011.

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