Weight, BodyLAPSNCT03522168
Long-term Antipsychotic Pediatric Safety Trial
An observational study of Weight, Body, run by Duke University at 37 sites in United States.
Trial summary
Main LAP01 study: The purpose is to evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 - <18-year-old children, who have varying durations of prior antipsychotic drug exposure from the start of study Month 0 (M0). Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Weight, Body
- What is being tested?
- Risperidone and Aripiprazole
- How many people
- 509 participants
- Where
- 37 sitesUnited States
- Study dates
- 10 Jan 2019to 21 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Main Study: The study population will consist of two groups of children 3 - <18 yrs old at the M0 visit: * Risperidone group, n=350, including 30 children 3 - <6 yrs old and 320 children 6 - <18 yrs old, ~ 50% - 80% will have <90 days of prior treatment with any antipsychotic. * Aripiprazole group, n=350, including 30 children 3 - <6 yrs old and 320 children 6 - <18 yrs old., ~ 50% - 80% will have ≤90 days of prior treatment with any antipsychotic. We will target participants within each treatment group to be distributed across the age range to permit analyses of age effects with: * ~30 being 3 - <6 years * ≥35% (n ≥123) being 6 - <12 years * ≥35% (n ≥123) being 12 - <18 years PK sub group at selected sites includes 24 participates, details in protocol. Registry Sub-Study Registry participants will be selected exclusively from the population that has enrolled onto the LAPS Trial.
Who may be able to join
- Parent/guardian has provided informed consent
- Participant has provided assent if developmentally appropriate and as required by the institutional review board (IRB)
- 3 - <18 years of age inclusive at time of M0 visit
- Participant, when developmentally appropriate, and parent/guardian are:
- Willing to authorize exchange of information between the SS and the participant's PPPMP and/or other significant medical provider
- Affirm participant's use at M0 visit of either risperidone or aripiprazole mono-antipsychotic therapy as prescribed by participant's PPPMP
Show all 25Show fewer
- Based on their age at the time of M0 visit, participant is receiving aripiprazole or risperidone at the dose and for the diagnoses as listed below:
- Participants ages 3 - < 6 years can have any diagnosis and any dose
- Participants ages ≥ 6 - <18 years at the doses and for the diagnoses listed below
- Labeled Indications (Closely Related Disorders)
- Aripiprazole 2-30 mg/day
- Irritability associated with autistic disorder:
- (Irritability in autism spectrum disorder) - Treatment of Tourette's disorder: (Tourette's disorder, persistent (chronic) motor or vocal tic disorder)
- Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar l disorder: (Bipolar spectrum disorders including disruptive mood dysregulation disorder)
- Schizophrenia: (Schizophrenia spectrum disorders including schizoaffective disorder, psychosis not otherwise specified, and delusional disorder)
- Risperidone 0.25-6 mg/day - Irritability associated with autistic disorder: (Irritability in autism spectrum disorder)
- Bipolar Mania: (Bipolar spectrum disorders including disruptive mood dysregulation disorder)
- Schizophrenia: (Schizophrenia spectrum disorders including schizoaffective disorder, psychosis not otherwise specified, and delusional disorder)
- MYCITE® (aripiprazole) and all forms of injectables are not permitted in this study
- Guardian anticipates risperidone or aripiprazole treatment will continue for ≥6 months
- Enrolled in LAPS Trial
- Access to a personal mobile device (with Bluetooth capability and data or internet access) and willing to use it for the purposes of this study
- Parent/guardian/LAR/participant has provided informed consent
- Participant has provided assent/consent if developmentally appropriate and as required by the institutional review board (IRB)
- Participant was part of the 6 to <18 year-old group in the LAPS Trial
Who cannot join
- History of prior or current diagnosis of an eating disorder or meets diagnostic criteria for an eating disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and determined by psychiatric exam
- Pre-existing or suspected major medical, metabolic, or genetic condition that is expected to be associated with weight, cardiovascular, neuromotor, or endocrine problems
- Known or self-reported pregnancy
- Taking antipsychotic medication other than either risperidone or aripiprazole at the time of M0 visit
- Contraindications to participation in the study in the opinion of the SMC
- Unwilling or unable to provide back-up family contact information
- Registry Sub-Study
- 1. Participant has completed the M24 LAPS Trial Visit
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
BioBehavioral Research of Austin
Austin, Texas, 78759
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Neurobehavioral Medicine Group
Bloomfield, Michigan, 48302
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Virginia
Charlottesville, Virginia, 22903
University of Cincinnati
Cincinnati, Ohio, 45219-2492
Valley Healthcare System
Columbus, Georgia, 31903
Harmonex Neuroscience Research
Dothan, Alabama, 36303
Duke Child and Family Study Center
Durham, North Carolina, 27705
Cook Children's Medical Center
Fort Worth, Texas, 76104
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548
IACT Health
Grayson, Georgia, 30017
Behavioral Health Hospital Oupatient Clinic
Greensboro, North Carolina, 27278
Cone Health Outpatient Behavioral Health
Greensboro, North Carolina, 27403
Baylor College of Medicine
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
OM Research
Lancaster, California, 93594
Massachusetts General Hospital, Lurie Center for Autism
Lexington, Massachusetts, 02421
Arkansas Children's Research Institute
Little Rock, Arkansas, 72202
UCLA Semel Institute
Los Angeles, California, 90024
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Clinical Trials Solution
Miami, Florida, 33126
South Florida Behavioral Health Network
Miami, Florida, 33126
AMR-Baber Research, Inc.
Naperville, Illinois, 60563
Yale Child Study Center
New Haven, Connecticut, 06520
Scientific Clinical Research, Inc.
North Miami, Florida, 33161
University of Nebraska Medical Center
Omaha, Nebraska, 68131
Southwest Autism Research & Resource Center
Phoenix, Arizona, 85006
Carolina Partners in Mental HealthCare, PLLC
Raleigh, North Carolina, 27609
Avera McKennan University Psychiatry Associates
Sioux Falls, South Dakota, 57108
Attalla Consultants LLC dba Institute for Behavioral Medicine
Smyrna, Georgia, 30082
Beacon Medical Group
South Bend, Indiana, 46601
Washington University
St Louis, Missouri, 63110
Montefiore Medical Center, Albert Einstein College of Medicine
The Bronx, New York, 10461
Neuropsychiatric Associates
Woodstock, Vermont, 05091
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Pediatric Trials Network Long-term Antipsychotic Pediatric Safety Trial (LAPS) NICHD-2016-LAP01 Phase 4 Trial
Main LAP01 study: The purpose is to evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 - <18-year-old children, who have varying durations of prior antipsychotic drug exposure from the start of study Month 0 (M0). This is critical because children appear to have greater vulnerability to antipsychotic-associated weight gain than adults, and obesity has significant effects on morbidity and mortality.
An additional sub-study (registry sub-study) was added via a protocol amendment. This registry sub-study is optional for participants and only participants who participate in the main study are eligible if they were 6 to less than 18 years of age at the time of the M0 visit. Participants who consent to this registry sub-study will participate in yearly in-person visits and complete monthly assessments remotely over the course of two additional years from the time of their final visit of the main LAP01 study.
Read the detailed description
Main LAP01 study: Prospective, multi-site, Phase 4, longitudinal observational study designed to systematically collect robust longitudinal post-marketing safety and quality of life data about multi-year pediatric treatment with risperidone or aripiprazole. Screening may occur for up to 37 days prior to enrollment. Assessments will occur at in-person visits planned at months 0, 6, 12, 18 and 24, and at unscheduled, in-person visits that study staff request when the participant switches or stops antipsychotic monotherapy with risperidone or aripiprazole, adds or stops treatment with a weight modifying agent, becomes pregnant, chooses to withdraw from the study prematurely or, has an ongoing Serious Adverse Event (SAE) that requires further assessment. Monthly remote interim contacts occurring between in-person visits will monitor for changes (other than dose related) in antipsychotic therapy or weight modifying treatments, potential SAEs, and potential pregnancy. The participant, his/her parent/guardian, and the participant's personal psychotropic-prescribing medical provider (PPPMP) will make any and all decisions related to antipsychotic medications, any other medications, and the participant's current mental state, developmental/psychiatric condition, and level of risk for potential harm to self or others independent of the study procedures and assessments. Study staff (SS) will share with the participant's PPPMP all lab results and changes in the participant's AEs or clinical presentation, which the study medical clinician (SMC) considers medically concerning based on the participant's assessment during in-person visits. If an emergency safety concern is evident during an in-person visit, the SMC will immediately assess the participant, following medical standard-of-care procedures, to determine whether the participant is safe to leave the clinic or requires additional emergency care. If new or worsening symptoms are reported by the participant or parent/guardian during remote interim contacts, the participant and/or parent/guardian will be instructed to contact the PPPMP directly.
Registry sub-study: Participants who choose to participate will consent via a mobile application (Pattern Health) and will measure their height and weight at home monthly (also collected through the Pattern Health mobile application). One questionnaire will be completed every 6 months via the Pattern Health mobile application. Yearly in-person visits will be conducted to obtain in-clinic height, weight, vital signs and review concomitant medications.
- Conditions
- Weight, Body
- Being tested
- Risperidone, Aripiprazole
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
Also called Risperdal
Medications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder
AripiprazoleDrug
Also called Abilify
Medications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder
| Study group | Role | What they receive |
|---|---|---|
| Risperidone group | Risperidone, n=350, including 30 children 3 - <6 years old and 320 children 6 - <18 years old. ~50% - ~80% of the entire group will have <90 days of prior treatment with any antipsychotic. Receives: Drug: Risperidone | |
| Aripiprazole group | Aripiprazole group, n=350, including 30 children 3 - <6 years old and 320 children 6 - <18 years old. ~50% - ~80% of the entire group will have ≤90 days of prior treatment with any antipsychotic. Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Trial: Change in BMI z-score
Longitudinally, evaluate the long term pathologic weight changes associated with multi- year risperidone or aripiprazole therapy over a period of 24 months in children ages 3 -<18 years with varying durations of prior antipsychotic drug exposure at the M0 visit. The primary analysis will focus on changes in the modified Body Mass Index (BMI) z- score in children 6 - <18 years old from M0 visit over 24 months of follow up.
Measured: Baseline, 24 months
Registry Sub-Study: Modified Body Mass Index (BMI) z-score
Evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy over a period of 24 to 50 months in children who were 6 to <18 years of age at the time of LAPS Trial enrollment
Measured: Up to 24 months
Secondary outcomes (19)
Main Trial: Measure of weight change
Change in BMI category and Modified BMI z-score increase of ≥1.0 unit from M0
Measured: Baseline, 24 months
Main Trial: Metabolic measures associated with risk of diabetes and cardiovascular disease
Clinical laboratory evaluations for high-sensitivity C-reactive protein (hs-CRP); hemoglobin A1c (Hgb A1c); Presence of acanthosis nigricans or, in females only, hirsuitism on physical exam
Measured: Baseline, 24 months
Main Trial: Prolactin related outcomes
Clinical laboratory evaluation of serum prolactin; Incidence of gynecomastia in males on physical exam
Measured: Baseline, 24 months
Main Trial: Uniformly Elicited Events of Special Interest
A standardized semi-structured interview will be used by the SMC to assess events of special interest in all participants at every in-person visit [56]. The form queries for potential hospitalizations, emergency department visits, and urgent care visits and for pregnancy. The form also evaluates frequent or especially concerning adverse effects seen with antipsychotics including behavioral events. Targeted symptoms are: Sedation, Increased sleep, Problems with attention, thinking or learning Insomnia, Arrhythmias, Light-headedness (Orthostasis vs Vertigo), Seizures, Increased appetite, Decreased appetite, Tics, Tremors, Parkinsonian symptoms, Akathisia, Drooling, Dyskinesia, Polydipsia, Polyuria, Enuresis, Galactorrhea, Amenorrhea, Sexual dysfunction/anorgasmia, Diabetes, Fractures Menorrhagia, Lack of satiety
Measured: Baseline, 24 months
Main Trial: Adverse effects
Serious adverse events Adverse events (AEs) of mild (grade 1) severity and related to risperidone or aripiprazole All adverse events of moderate (grade 2) severity or greater regardless of relatedness to risperidone or aripiprazole
Measured: Baseline, 24 months
Main Trial: Suicidality
Assessed using DASS
Measured: Baseline, 24 months
Main Trial: Neuromotor effects
Abnormal Involuntary Movement Scale (AIMS) Simpson Angus Extrapyramidal Symptoms Scale (SAS)
Measured: Baseline, 24 months
Main Trial: AEs (Adverse Events)
Elicited AEs, including AEs of mild (grade 1) and related to risperidone or aripiprazole, and all AEs of moderate (grade 2) or greater and clinically significant changes in suicidality.
Measured: Baseline, 24 months
Main Trial: Pediatric Quality of Life Inventory
Relationship of risperidone or aripiprazole therapy to adaptive functioning and quality of life as assessed by the Pediatric Quality of Life Inventory (PedsQL, 23 item), and changes in the intensity or frequency of pre-existing behavioral problems indicated at M0 (baseline). The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization in individuals aged 2 years and older. The main scales include physical functioning, emotional functioning, social functioning, and school functioning. Summary scores can also be utilized to measure change over time on a five point scale for 0 = "Never a Problem" to 5 = "Almost Always a Problem". The guardian will be asked to complete the parent version for reporting on their child's quality of life.
Measured: Baseline, 24 months
Main Trial: School and Work Questionnaire (SWQ)
Relationship of risperidone or aripiprazole therapy with age-appropriate skip patterns, school promotions and graduations, changes in school supports, type of living situations, romantic relationships, arrests, and types and extent of employment during the interval since the prior assessment.
Measured: Baseline, 24 months
Main Trial: Caregiver Strain Questionnaire (CSQ)
Relationship of risperidone or aripiprazole therapy to adaptive functioning and quality of life as assessed ) by the Caregiver Strain Questionnaire (CSQ) and changes in the intensity or frequency of pre-existing behavioral problems indicated at M0 (baseline). This is a 21-item questionnaire with a categorical scale ranging from 1 (not at all a problem) to 5 (very much a problem) that assesses the caregiver's quality of life. It asks specifically about the caregiver's quality of life by assessing the impact of caring for a child with emotional and behavioral problems. The questions include information about disruption of family life and relationships; demands on time; negative, mental, and physical health effects for any family member; financial strain; feelings of sacrifice; disruption of social/community life; worry/guilt; fatigue/strain; and embarrassment.
Measured: Baseline, 24 months
Main Trial: Delighted-Terrible Faces Scale (DTFS)
Relationship of risperidone or aripiprazole therapy to adaptive functioning and quality of life as assessed by the Delighted-Terrible Faces Scale (DTFS) and changes in the intensity or frequency of pre-existing behavioral problems indicated at M0 (baseline). The DTFS is a uni-dimensional, single item scale that will be used to assess the participant's perceived life quality. Faces expressing various feelings are depicted, and the participant is asked which face comes closest to expressing how he/she feels about his/her life over the past month. The participant can then select from the range of seven categorical faces depicting from one-delighted to seven-terrible expressions. This scale is included because it can be easily completed by participants with limited verbal and cognitive abilities as well as by very young children.
Measured: Baseline, 24 months
Main Trial: PK CL/F
CL/F, apparent total clearance of the drug from plasma after oral administration at steady state
Measured: 24 months
Main Trial: PK Vss/F
Vss/F, apparent volume of distribution at steady state after non-intravenous administration at steady state
Measured: 24 months
Main Trial: PK AUCss
AUCss, area under the curve at steady state
Measured: 24 months
Main Trial: PK Cmax
Cmax, maximum concentration at steady state
Measured: 24 months
Main Trial: PK Tmax
Tmax, time of maximum concentration at steady state
Measured: 24 months
Main Trial: PK T1/2
T1/2, half-life at steady state
Measured: 24 months
Registry Sub-Study: Parent/guardian/former guardian/LAR completed Pediatric Quality of Life Inventory (PedsQL, 23 item) survey.
Change in PedsQL outcomes over time from M0 LAPS Trial in-person visit to R24 LAPS Registry mobile data collection
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start10 Jan 2019
- Primary completion21 Nov 2023
- Study completion21 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight, BodyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The Emmes Company, LLC
- Responsible party
- Principal investigator, Daniel Benjamin, Duke University
- Investigators
- Linmarie Sikich, MD, Principal investigator, Duke Clinical Research Institution (DCRI)Kevin Watt, MD, PhD, Principal investigator, University of UtahKaran Kumar, MD, MS, Principal investigator, Duke Clinical Research Institution (DCRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522168
- Sponsor's protocol ID
- Pro00084468
- Acronym
- LAPS
- Status last verified
- Apr 2026
- First submitted
- 18 Apr 2018
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected is uploaded into the National Institute of Health data repository (DASH) at the end of the study (de-identified).
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Trials Network Long-term Antipsychotic Pediatric Safety Trial (LAPS) NICHD-2016-LAP01 Phase 4 Trial
- ClinicalTrials.gov ID
- NCT03522168
- Acronym / sponsor ID
- LAPS / Pro00084468
- Conditions
- Weight, Body
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The Emmes Company, LLC
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 21 Nov 2023 (actual)
- Study completion
- 21 Nov 2023 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Main LAP01 study: The purpose is to evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy in 3 - <18-year-old children, who have varying durations of prior antipsychotic drug exposure from the start of study Month 0 (M0). This is critical because children appear to have greater vulnerability to antipsychotic-associated weight gain than adults, and obesity has significant effects on morbidity and mortality.
An additional sub-study (registry sub-study) was added via a protocol amendment. This registry sub-study is optional for participants and only participants who participate in the main study are eligible if they were 6 to less than 18 years of age at the time of the M0 visit. Participants who consent to this registry sub-study will participate in yearly in-person visits and complete monthly assessments remotely over the course of two additional years from the time of their final visit of the main LAP01 study.
Detailed description
Main LAP01 study: Prospective, multi-site, Phase 4, longitudinal observational study designed to systematically collect robust longitudinal post-marketing safety and quality of life data about multi-year pediatric treatment with risperidone or aripiprazole. Screening may occur for up to 37 days prior to enrollment. Assessments will occur at in-person visits planned at months 0, 6, 12, 18 and 24, and at unscheduled, in-person visits that study staff request when the participant switches or stops antipsychotic monotherapy with risperidone or aripiprazole, adds or stops treatment with a weight modifying agent, becomes pregnant, chooses to withdraw from the study prematurely or, has an ongoing Serious Adverse Event (SAE) that requires further assessment. Monthly remote interim contacts occurring between in-person visits will monitor for changes (other than dose related) in antipsychotic therapy or weight modifying treatments, potential SAEs, and potential pregnancy. The participant, his/her parent/guardian, and the participant's personal psychotropic-prescribing medical provider (PPPMP) will make any and all decisions related to antipsychotic medications, any other medications, and the participant's current mental state, developmental/psychiatric condition, and level of risk for potential harm to self or others independent of the study procedures and assessments. Study staff (SS) will share with the participant's PPPMP all lab results and changes in the participant's AEs or clinical presentation, which the study medical clinician (SMC) considers medically concerning based on the participant's assessment during in-person visits. If an emergency safety concern is evident during an in-person visit, the SMC will immediately assess the participant, following medical standard-of-care procedures, to determine whether the participant is safe to leave the clinic or requires additional emergency care. If new or worsening symptoms are reported by the participant or parent/guardian during remote interim contacts, the participant and/or parent/guardian will be instructed to contact the PPPMP directly.
Registry sub-study: Participants who choose to participate will consent via a mobile application (Pattern Health) and will measure their height and weight at home monthly (also collected through the Pattern Health mobile application). One questionnaire will be completed every 6 months via the Pattern Health mobile application. Yearly in-person visits will be conducted to obtain in-clinic height, weight, vital signs and review concomitant medications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risperidone group | – | Drug: RisperidoneRisperidone, n=350, including 30 children 3 - <6 years old and 320 children 6 - <18 years old. ~50% - ~80% of the entire group will have <90 days of prior treatment with any antipsychotic. |
| Aripiprazole group | – | Drug: AripiprazoleAripiprazole group, n=350, including 30 children 3 - <6 years old and 320 children 6 - <18 years old. ~50% - ~80% of the entire group will have ≤90 days of prior treatment with any antipsychotic. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Main Study: The study population will consist of two groups of children 3 - <18 yrs old at the M0 visit: * Risperidone group, n=350, including 30 children 3 - <6 yrs old and 320 children 6 - <18 yrs old, ~ 50% - 80% will have <90 days of prior treatment with any antipsychotic. * Aripiprazole group, n=350, including 30 children 3 - <6 yrs old and 320 children 6 - <18 yrs old., ~ 50% - 80% will have ≤90 days of prior treatment with any antipsychotic. We will target participants within each treatment group to be distributed across the age range to permit analyses of age effects with: * ~30 being 3 - <6 years * ≥35% (n ≥123) being 6 - <12 years * ≥35% (n ≥123) being 12 - <18 years PK sub group at selected sites includes 24 participates, details in protocol. Registry Sub-Study Registry participants will be selected exclusively from the population that has enrolled onto the LAPS Trial.
Key inclusion criteria (25 listed)
- Parent/guardian has provided informed consent
- Participant has provided assent if developmentally appropriate and as required by the institutional review board (IRB)
- 3 - <18 years of age inclusive at time of M0 visit
- Participant, when developmentally appropriate, and parent/guardian are:
- Based on their age at the time of M0 visit, participant is receiving aripiprazole or risperidone at the dose and for the diagnoses as listed below:
Key exclusion criteria (8 listed)
- History of prior or current diagnosis of an eating disorder or meets diagnostic criteria for an eating disorder as described in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and determined by psychiatric exam
- Pre-existing or suspected major medical, metabolic, or genetic condition that is expected to be associated with weight, cardiovascular, neuromotor, or endocrine problems
- Known or self-reported pregnancy
- Taking antipsychotic medication other than either risperidone or aripiprazole at the time of M0 visit
- Contraindications to participation in the study in the opinion of the SMC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RisperidoneAlso: RisperdalMedications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder | Drug | Risperidone group |
| AripiprazoleAlso: AbilifyMedications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder | Drug | Aripiprazole group |
Primary outcome
Main Trial: Change in BMI z-score
Time frame: Baseline, 24 months
Longitudinally, evaluate the long term pathologic weight changes associated with multi- year risperidone or aripiprazole therapy over a period of 24 months in children ages 3 -<18 years with varying durations of prior antipsychotic drug exposure at the M0 visit. The primary analysis will focus on changes in the modified Body Mass Index (BMI) z- score in children 6 - <18 years old from M0 visit over 24 months of follow up.
Registry Sub-Study: Modified Body Mass Index (BMI) z-score
Time frame: Up to 24 months
Evaluate the long-term pathologic weight changes associated with multi-year risperidone or aripiprazole therapy over a period of 24 to 50 months in children who were 6 to <18 years of age at the time of LAPS Trial enrollment
19 secondary outcomes
Main Trial: Measure of weight change
Time frame: Baseline, 24 months
Main Trial: Metabolic measures associated with risk of diabetes and cardiovascular disease
Time frame: Baseline, 24 months
Main Trial: Prolactin related outcomes
Time frame: Baseline, 24 months
Main Trial: Uniformly Elicited Events of Special Interest
Time frame: Baseline, 24 months
Main Trial: Adverse effects
Time frame: Baseline, 24 months
Main Trial: Suicidality
Time frame: Baseline, 24 months
Main Trial: Neuromotor effects
Time frame: Baseline, 24 months
Main Trial: AEs (Adverse Events)
Time frame: Baseline, 24 months
Main Trial: Pediatric Quality of Life Inventory
Time frame: Baseline, 24 months
Main Trial: School and Work Questionnaire (SWQ)
Time frame: Baseline, 24 months
Main Trial: Caregiver Strain Questionnaire (CSQ)
Time frame: Baseline, 24 months
Main Trial: Delighted-Terrible Faces Scale (DTFS)
Time frame: Baseline, 24 months
Main Trial: PK CL/F
Time frame: 24 months
Main Trial: PK Vss/F
Time frame: 24 months
Main Trial: PK AUCss
Time frame: 24 months
Main Trial: PK Cmax
Time frame: 24 months
Main Trial: PK Tmax
Time frame: 24 months
Main Trial: PK T1/2
Time frame: 24 months
Registry Sub-Study: Parent/guardian/former guardian/LAR completed Pediatric Quality of Life Inventory (PedsQL, 23 item) survey.
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. All data collected is uploaded into the National Institute of Health data repository (DASH) at the end of the study (de-identified).
Related trials for Weight, Body
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linmarie Sikich, MD principal investigator
Duke Clinical Research Institution (DCRI)
Kevin Watt, MD, PhD principal investigator
University of Utah
Karan Kumar, MD, MS principal investigator
Duke Clinical Research Institution (DCRI)
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight, Body, run by Duke University at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Trial: Change in BMI z-score (time frame: Baseline, 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.