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Comparison of Bone Mineral Density Changes During Tx With Risperidone or Aripiprazole in Adolescents

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ClinicalTrials.gov Identifier: NCT00573716
Recruitment Status : Completed
First Posted : December 14, 2007
Last Update Posted : August 4, 2011
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Creighton University

Brief 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.

Condition or disease
Psychiatry

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Comparison of Bone Mineral Density Changes During Treatment With Risperidone or Aripiprazole in Adolescents
Study Start Date : October 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Group/Cohort
1
15 subjects who are taking aripiprazole monotherapy
2
15 subjects who are taking Risperidone therapy
3
30 healthy volunteers with an ethnicity, sex, and pubertal stage match of subjects taking aripiprazole monotherapy and Risperidone therapy



Primary Outcome Measures :
  1. That compared to risperidone, pediatric aripiprazole therapy is not associated with hyperprolactinemia and reduced bone mineral content and/or altered bone metabolism [ Time Frame: This is a 2-visit study ]


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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from psychiatry clinic and community resources
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573716


Locations
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United States, Nebraska
Creighton Department of Psychiatry
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Bristol-Myers Squibb
Investigators
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Principal Investigator: Sriram Ramaswamy, M.D. Creighton University

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Responsible Party: Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry, Creighton University
ClinicalTrials.gov Identifier: NCT00573716     History of Changes
Other Study ID Numbers: 06-14240
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: August 4, 2011
Last Verified: August 2011
Keywords provided by Creighton University:
bone mineral content
aripiprazole monotherapy
risperidone monotherapy
Additional relevant MeSH terms:
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Risperidone
Aripiprazole
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists