Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
Public ClinicalTrials.gov record NCT01731119. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Pilot Study of Lurasidone in Treating Antipsychotic Naive or Quasi-Naive Children and Adolescents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The overarching purpose of this pilot study is to collect preliminary data regarding the variability of weight gain associated with lurasidone (Latuda©) treatment of antipsychotic naive children and adolescents in order to inform decisions about including a lurasidone arm in a future large scale trial of different approaches to minimize antipsychotic associated weight gain in the pediatric population. In adults, lurasidone appears to cause minimal weight gain. The participants will be 6-19 years old with psychotic spectrum, mood spectrum, or autism spectrum disorders. They will have 4 weeks or less of lifetime antipsychotic exposure.
Study identification
- NCT ID
- NCT01731119
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 9 participants
Conditions and interventions
Conditions
- Schizophrenia
- Schizoaffective Disorder
- Schizophreniform Disorder
- Psychosis NOS
- Autistic Disorder
- Asperger Syndrome
- Child Development Disorders, Pervasive
- Bipolar I Disorder
- Bipolar II Disorder
- Mood Disorder NOS
- Severe Major Depression With Psychotic Features
- Single Episode Major Depression Without Psychotic Symptoms
- Severe Mood Disorder With Psychotic Features
Eligibility (public fields only)
- Age range
- 6 Years to 19 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 2012 (Type not available)
- Primary completion
- Aug 2014 (Actual)
- Completion
- Aug 2014 (Actual)
- Last update posted
- Jun 14, 2017
2012 – 2014
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27517 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01731119, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 14, 2017 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01731119 live on ClinicalTrials.gov.