Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198107
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2005-09-12
Brief Title:
Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Sponsor:
Indiana University
Organization:
Indiana University
Study Overview
Official Title:
Novel Pharmacological Strategies in Autism
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children
Detailed Description:
Autism is a developmental disorder that affects every child differently A wide range of symptoms accompany autism including self-injurious behavior aggression and severe tantrums Despite an improved ability to reduce these symptoms existing drug treatments continue to be associated with adverse side effects Also there is no existing drug treatment that reliably improves social behavior a core deficit in autism Studies on drug treatment combinations that are designed to reduce self-injurious behavior aggression and severe tantrums and improve social behavior in children with autism have yet to be conducted This study will address the above-mentioned limitations by evaluating aripiprazole in reducing self-injurious behavior aggression and severe tantrums and by evaluating the addition of D-Cycloserine in improving social behavior among children with autism
This study will include three phases and an add-on component for some children Participants will be randomly assigned to receive either aripiprazole or a placebo treatment for 8 weeks Assessments measuring irritability behavior and social skills will be conducted at the end of this first phase Those patients who respond well to aripiprazole will continue to receive aripiprazole treatment for another 16 weeks This second phase will determine whether aripiprazole is associated with long-term maintenance of symptomatic improvement in patients who respond well to short-term treatment Assessments will again be conducted at the end of this 16-week period Those patients whose symptoms have stabilized and continue to improve while on aripiprazole will be asked to participate in the final phase of this study During the this pilot phase D-Cycloserine will be added to ongoing treatment with aripiprazole Patients will take both aripiprazole and D-Cycloserine for an additional 8 weeks to determine if this combination of drug treatments results in improved social behavior once patients aggression and self-injurious behavior have been stabilized with aripiprazole At the end of this 8-week period participants will be assessed for any changes in behavior irritability or social skills Results from this study may aid in developing safer and more effective drug treatments for children and adolescents with autism
This study will include three phases and an add-on component for some children Participants will be randomly assigned to receive either aripiprazole or a placebo treatment for 8 weeks Assessments measuring irritability behavior and social skills will be conducted at the end of this first phase Those patients who respond well to aripiprazole will continue to receive aripiprazole treatment for another 16 weeks This second phase will determine whether aripiprazole is associated with long-term maintenance of symptomatic improvement in patients who respond well to short-term treatment Assessments will again be conducted at the end of this 16-week period Those patients whose symptoms have stabilized and continue to improve while on aripiprazole will be asked to participate in the final phase of this study During the this pilot phase D-Cycloserine will be added to ongoing treatment with aripiprazole Patients will take both aripiprazole and D-Cycloserine for an additional 8 weeks to determine if this combination of drug treatments results in improved social behavior once patients aggression and self-injurious behavior have been stabilized with aripiprazole At the end of this 8-week period participants will be assessed for any changes in behavior irritability or social skills Results from this study may aid in developing safer and more effective drug treatments for children and adolescents with autism
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR 82-SEDR | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH072961 |
| R01MH072961 | NIH | None | None |