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Comparison of Bone Mineral Density Changes During Tx With Risperidone or Aripiprazole in Adolescents
This study is ongoing, but not recruiting participants.
First Received: December 12, 2007   Last Updated: April 16, 2009   History of Changes
Sponsors and Collaborators: Creighton University
Bristol-Myers Squibb
Information provided by: Creighton University
ClinicalTrials.gov Identifier: NCT00573716
  Purpose

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
Psychiatry

MedlinePlus related topics: Minerals
Drug Information available for: Risperidone Aripiprazole
U.S. FDA Resources
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

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
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

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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573716

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

No publications provided

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

Keywords provided by Creighton University:
bone mineral content
aripiprazole monotherapy
risperidone monotherapy

Study placed in the following topic categories:
Neurotransmitter Agents
Dopamine
Tranquilizing Agents
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Agents
Aripiprazole
Antipsychotic Agents
Serotonin

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009