LAPS

LAPS Trial Meets Study and Sub-Study Milestones

Posted on by Meagan.daly@duke.edu

Child writing with pencil

The PTN Long-term Antipsychotic Pediatric Safety (LAPS) Trial, which aims to assess the long-term health of risperidone and aripiprazole in children, has enrolled more than 500 children in the main study. Risperidone and aripiprazole have been shown to be effective for the treatment of conditions such as schizophrenia and bipolar disorder in adults and children. However, it is common for these drugs to be prescribed without FDA approval for conditions such as attention-deficit disorder, obsessive-compulsive disorder, and major depression. Regardless of indication, little is known about the long-term health risks and quality-of-life benefits for their use in children.

In addition to the main study, the team has established a sub-study registry that will continue to collect height and weights, from home, via the Pattern Health mobile app. This will allow for continued longitudinal assessment of pathologic weight change associated with these antipsychotics.  In addition to the use of the app, parents of participants will also complete quality of life questionnaires, every six months, for their children participating in the sub-study. The team has enrolled more than 250 children in the sub-study portion of LAPS.

The ultimate goal of the both the main study and sub-study is to provide long-term data to the FDA to update the risperidone and aripiprazole labels to include correct safety and dosing information. This information will allow doctors to provide the safest, most effective dose to children who require treatment with antipsychotics.

LAPS trial achieves substantial enrollment milestone

Posted on by Meagan.daly@duke.edu

The PTN Long-term Antipsychotic Pediatric Safety (LAPS) Trial has now passed the halfway mark of enrollment, marking a substantial study milestone.

The two-year LAPS study will follow children aged 3 to 17 who are already taking an antipsychotic (risperidone or aripiprazole) to treat disorders such as schizophrenia, bipolar disorder, and irritability associated with autism. The study will assess both the long-term health risks and quality-of-life benefits of these two drugs, which have been shown to be effective and may even prevent mental illness in adulthood.

“Antipsychotic treatment of children and adolescents has greatly increased over the past 20 years,” said Dr. Linmarie Sikich, principal investigator for the study and associate professor in the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine. “At the same time, new evidence suggests an association between antipsychotic use and weight gain. In addition, the incidence of long-term adverse effects such as involuntary movements and hormonal changes is unknown.”

The goal of LAPS is to assess the long-term health risks of risperidone and aripiprazole in children. While several antipsychotics are FDA-approved in children, it is common for these drugs to be prescribed without FDA approval for conditions such as attention-deficit disorder, obsessive-compulsive disorder, and major depression.

The enrollment of more than 350 children helps achieve 50 percent of the overall enrollment goal and is a key accomplishment for the two-year observational study.

PTN LAPS Trial enrolls more than 100 patients

Posted on by Meagan.daly@duke.edu

The PTN Long-term Antipsychotic Pediatric Safety (LAPS) Trial, which aims to assess the long-term health risks of risperidone and aripiprazole in children, has now enrolled more than 100 children. Risperidone and aripiprazole have been shown to be effective for the treatment of conditions such as schizophrenia and bipolar disorder in adults, but little is known about the long-term health risks and quality-of-life benefits for their use in children.

While several antipsychotics are FDA-approved in children, it is common for these drugs to be prescribed without FDA approval for conditions such as attention-deficit disorder, obsessive-compulsive disorder, and major depression.

The ultimate goal of the study is to provide long-term safety data to the FDA to update the risperidone and aripiprazole labels to include correct safety and dosing information. This information will allow doctors to provide the safest, most effective dose to children who require treatment with antipsychotics.

The enrollment of more than 100 children helps achieve nearly 30 percent of the overall enrollment goal of the LAPS Trial and is a key accomplishment for the two-year observational study.

First site activated for LAPS study on antipsychotic use in children

Posted on by Kayla Korzekwinski

The first site has been activated for the Long-term Antipsychotic Pediatric Safety (LAPS) Trial, which aims to determine the safety of long-term antipsychotic treatments in children. Dr. Ahmed Elmaadawi’s was the first site activated on Tuesday, Dec. 11. Dr. Elmaadawi is the director of the Interventional Psychiatry Program at Beacon Health System in South Bend, Ind.

The two-year LAPS study will follow children aged 3 to 17 who are already taking an antipsychotic (risperidone or aripiprazole) to treat disorders such as schizophrenia, bipolar disorder, and irritability associated with autism. The study will assess both the long-term health risks and quality-of-life benefits of these two drugs, which have been shown to be effective and may even prevent mental illness in adulthood.

Dr. Linmarie Sikich

“Antipsychotic treatment of children and adolescents has greatly increased over the past 20 years,” said Dr. Linmarie Sikich, principal investigator for the study and associate professor in the Department of Psychiatry and Behavioral Sciences at the Duke University School of Medicine. “At the same time, new evidence suggests an association between antipsychotic use and weight gain. In addition, the incidence of long-term adverse effects such as involuntary movements and hormonal changes is unknown.”

These findings have led to a growing concern that the potential benefits of long-term antipsychotic use may not outweigh the risks, especially for children.

While several antipsychotics are FDA-approved in children, it is common for these drugs to be prescribed without FDA approval for conditions such as attention-deficit disorder, obsessive-compulsive disorder, and major depression. Antipsychotics are also frequently used to promote weight gain and reduce anxiety in children and teens with eating disorders.

The ultimate goal of the study is to provide long-term safety data to the FDA to update the risperidone and aripiprazole labels to include correct safety and dosing information. This information will allow doctors to provide the safest, most effective dose to children who require treatment with antipsychotics.