NCT00573716

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 4, 2011

Status Verified

August 1, 2011

Enrollment Period

2.7 years

First QC Date

December 12, 2007

Last Update Submit

August 3, 2011

Conditions

Psychiatry

Keywords

bone mineral contentaripiprazole monotherapyrisperidone monotherapy

Outcome Measures

Primary Outcomes (1)

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

    This is a 2-visit study

Study Arms (3)

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

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Subjects will be recruited from psychiatry clinic and community resources

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton Department of Psychiatry

Omaha, Nebraska, 68131, United States

Location

Study Officials

  • Sriram Ramaswamy, M.D.

    Creighton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2007

First Posted

December 14, 2007

Study Start

October 1, 2006

Primary Completion

June 1, 2009

Study Completion

October 1, 2009

Last Updated

August 4, 2011

Record last verified: 2011-08

Locations

US(1)