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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00573716
First received: December 12, 2007
Last updated: August 3, 2011
Last verified: August 2011
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: A Comparison of Bone Mineral Density Changes During Treatment With Risperidone or Aripiprazole in Adolescents

Resource links provided by NLM:


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 ]

Estimated Enrollment: 60
Study Start Date: October 2006
Study Completion Date: October 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Sriram Ramaswamy, M.D., Assistant Professor of Psychiatry, Creighton University
ClinicalTrials.gov Identifier: NCT00573716     History of Changes
Other Study ID Numbers: 06-14240
Study First Received: December 12, 2007
Last Updated: August 3, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Aripiprazole
Risperidone
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 21, 2014