Status:
COMPLETED
Bone Mineral Content and Bone Metabolism in Adolescents on Antipsychotic Therapy
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Thrasher Research Fund
Conditions:
Adolescent Depression
Eligibility:
All Genders
10-17 years
Brief 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. To d...
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 Admin...
Eligibility Criteria
Inclusion
- 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 -
Exclusion
- 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. -
Key Trial Info
Start Date :
October 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00399776
Start Date
October 1 2006
End Date
September 1 2009
Last Update
August 4 2011
Active Locations (1)
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1
Creighton University Psychiatry Research Center
Omaha, Nebraska, United States, 68131