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

Creighton University

Status: Completed

Conditions: Psychiatry

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00573716

06-14240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 3 patient groups

1

Description:

15 subjects who are taking aripiprazole monotherapy

2

Description:

15 subjects who are taking Risperidone therapy

3

Description:

30 healthy volunteers with an ethnicity, sex, and pubertal stage match of subjects taking aripiprazole monotherapy and Risperidone therapy