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Sponsors and Collaborators: |
Creighton University Bristol-Myers Squibb |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00573716 |
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.
Condition |
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Psychiatry |
Study Type: | Observational |
Study Design: | Case Control, Retrospective |
Official Title: | A Comparison of Bone Mineral Density Changes During Treatment With Risperidone or Aripiprazole in Adolescents |
Estimated Enrollment: | 60 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts |
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1
15 subjects who are taking aripiprazole monotherapy
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2
15 subjects who are taking Risperidone therapy
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3
30 healthy volunteers with an ethnicity, sex, and pubertal stage match of subjects taking aripiprazole monotherapy and Risperidone therapy
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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.
Ages Eligible for Study: | 11 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Subjects will be recruited from psychiatry clinic and community resources
Inclusion Criteria:
Exclusion Criteria:
United States, Nebraska | |
Creighton Department of Psychiatry | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Sriram Ramaswamy, M.D. | Creighton University |
Responsible Party: | Creighton University ( Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry ) |
Study ID Numbers: | 06-14240 |
Study First Received: | December 12, 2007 |
Last Updated: | April 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00573716 History of Changes |
Health Authority: | United States: Institutional Review Board |
bone mineral content aripiprazole monotherapy risperidone monotherapy |
Neurotransmitter Agents Dopamine Tranquilizing Agents Psychotropic Drugs Risperidone |
Central Nervous System Depressants Dopamine Agents Aripiprazole Antipsychotic Agents Serotonin |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Risperidone Central Nervous System Depressants Dopamine Antagonists |
Antipsychotic Agents Pharmacologic Actions Serotonin Antagonists Serotonin Agents Therapeutic Uses Dopamine Agents Aripiprazole Central Nervous System Agents |