CompletedNot Applicable

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

United States60 participantsStarted 2006-10

Plain-language 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.

Who can participate

Age range

11 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

That compared to risperidone, pediatric aripiprazole therapy is not associated with hyperprolactinemia and reduced bone mineral content and/or altered bone metabolism

Timeframe: This is a 2-visit study

Trial details

NCT IDNCT00573716

SponsorCreighton University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2009-06

View on ClinicalTrials.gov More Psychiatry trials

Who can participate

Age range

11 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.