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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00573716
Other study ID # 06-14240
Secondary ID
Status Completed
Phase N/A
First received December 12, 2007
Last updated August 3, 2011
Start date October 2006
Est. completion date October 2009

Study information

Verified date August 2011
Source Creighton University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study examines if the use of antipsychotic medications might contribute to an interruption in bone mineral development and/or a reduction in bone mineral content in adolescents.


Description:

Studies have shown that some antipsychotic medications, including Risperdal, can increase prolactin levels in both adult and pediatric populations. Prolactin is a hormone made by the central nervous system. The main function of prolactin is to regulate lactation in females. However, having too much prolactin over time can interrupt bone mineral accrual and a decrease in bone density. Since peak bone mass is reached during adolescents, this is a key determinant of a lifetime risk of osteoporosis. On the other hand, there ahve been no reports of increased prolactin using Abilify. In fact, in adults Abilify has been shown to normalize or even lower prolactin levels. In this study, we will compare the amount of prolactin and bone mineral density of adolescents who take Risperdal or Abilify with bone mineral density of adolescents who do nto take antipsychotic medications. We will also compare the amount of prolactin and bone mineral density of adolescents who take Risperdal with those who take Abilify. This study will also help us to learn about the relationship between medications, prolactin levels, sex steroids, and bone formation markers in adolescents.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 11 Years to 17 Years
Eligibility Inclusion Criteria:

- Between the ages of 11 and 17 years

- Females and males on aripiprazole or risperidone monotherapy for minimum one year

- Within 10th and 90th percentile for height and weight

Exclusion Criteria:

- Pregnancy

- Chronic illness such as asthma, inflammatory bowel disease, rheumatoid disorders or cystic fibrosis, on chronic systemic steroid therapy for past 12 months

- Menstrual irregularities secondary to excessive physical activity

- History of anorexia nervosa and/or bulimia nervosa

- Subjects on hormonal contraception

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Creighton Department of Psychiatry Omaha Nebraska

Sponsors (2)

Lead Sponsor Collaborator
Creighton University Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary That compared to risperidone, pediatric aripiprazole therapy is not associated with hyperprolactinemia and reduced bone mineral content and/or altered bone metabolism This is a 2-visit study No
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