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.
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
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
- 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.
- 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.
- Conditions
- Adolescent Depression
- 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 group | Role | What they receive |
|---|---|---|
| Group A | Adolescents taking haloperidol, risperidone, or olanzapine Receives: Radiation: Bone Density Test | |
| Group B | Healthy adolescents Receives: Radiation: Bone Density Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antipsychotic induced hyperprolactinemia can decrease bone mineral accrual
Measured: This is a 2 visit study
Secondary outcomes (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.
- First posted15 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Investigators
- Sriram Ramaswamy, M.D., Principal investigator, Creighton University
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy
- ClinicalTrials.gov ID
- NCT00399776
- Acronym / sponsor ID
- 06-14216
- Conditions
- Adolescent Depression
- Keywords
- bone mineral, antipsychotic therapy, bone mineral accrual, bone mineral content
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Oct 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that antipsychotic induced hyperprolactinemia can decrease bone mineral accrual and decrease bone mineral content (BMC) in adolescents on antipsychotic therapy.
Specifics Aims
- 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.
- 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Radiation: Bone Density TestAdolescents taking haloperidol, risperidone, or olanzapine |
| Group B | – | Radiation: Bone Density TestHealthy adolescents |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects will be recruited from within the clinic as well as community psychiatrists
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Density TestEvaluating bone mineral content and bone metabolism in adolescents on antipsychotic therapy compared to healthy adolescents | Radiation | Group A, Group B |
Primary outcome
Antipsychotic induced hyperprolactinemia can decrease bone mineral accrual
Time frame: This is a 2 visit study
1 secondary outcome
Determine relationship between serum concentrations of prolactin, sex steroids and bone turnover markers in adolescents on antipsychotic therapy
Time frame: This is a 2 visit study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sriram Ramaswamy, M.D. principal investigator
Creighton University
1 site in 1 country: see every site and its status.
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.