Long-term Antipsychotic Pediatric Safety Trial

  • STATUS
    Recruiting
  • days left to enroll
    38
  • participants needed
    700
  • sponsor
    Duke University
Updated on 25 February 2021
Investigator
Lee Howard
Primary Contact
Arkansas Children's Research Institute (2.3 mi away) Contact
+39 other location

Summary

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.

Description

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 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, with the participant's PPPMP. 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.

Details
Condition Body Weight
Treatment risperidone, Aripiprazole
Clinical Study IdentifierNCT03522168
SponsorDuke University
Last Modified on25 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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 6. Guardian anticipates risperidone or aripiprazole treatment will continue for 6 months

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note