Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005014
Status:
COMPLETED
Last Update Posted:
2014-04-17
First Post:
2000-03-31
Brief Title:
Treatment of Autism in Children and Adolescents
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institute of Mental Health NIMH
Study Overview
Official Title:
Placebo-Controlled Study of Risperidone for the Treatment of Children and Adolescents With Autism and Negative Behavioral Symptoms
Status:
COMPLETED
Status Verified Date:
2010-08
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 is designed to determine the effectiveness of risperidone a drug treatment for the interfering symptoms of Autistic Disorder in children and adolescents between the ages of 5 and 17 Between 100 and 120 patients will be participating in this research study at five academic medical centers in the United States The primary aim of the treatment is to reduce impairing behavioral symptoms such as aggression explosive outbursts or self-injurious behavior without significant side effects A secondary aim is to evaluate possible improvement in the level of social relatedness attention motor coordination and short-term memory
This study is a placebo-controlled double-blind study neither the investigators nor patients know if the treatment being given is risperidone or an inactive substance placebo Patients will be asked to participate for 6 to 8 months For the first 8 weeks patients will receive either risperidone or placebo randomly chosen At the end of the 8 weeks those patients who have improved and were on risperidone will be asked to continue on this medication for another 4 months The last two months of the study are again double-blind neither patients nor investigators know treatment Patients will either continue risperidone treatment or be gradually tapered from risperidone placebo-substitution This blinded discontinuation phase will last 2 months during which patients will be closely monitored for recurrence or worsening of symptoms Patients who have been treated with placebo in the first 8 weeks of the study and have not improved will be treated with risperidone Weekly visits are required for the first 8 weeks of the study monthly visits for the following 4 months and weekly visits during the last 2 months of the study
This study is a placebo-controlled double-blind study neither the investigators nor patients know if the treatment being given is risperidone or an inactive substance placebo Patients will be asked to participate for 6 to 8 months For the first 8 weeks patients will receive either risperidone or placebo randomly chosen At the end of the 8 weeks those patients who have improved and were on risperidone will be asked to continue on this medication for another 4 months The last two months of the study are again double-blind neither patients nor investigators know treatment Patients will either continue risperidone treatment or be gradually tapered from risperidone placebo-substitution This blinded discontinuation phase will last 2 months during which patients will be closely monitored for recurrence or worsening of symptoms Patients who have been treated with placebo in the first 8 weeks of the study and have not improved will be treated with risperidone Weekly visits are required for the first 8 weeks of the study monthly visits for the following 4 months and weekly visits during the last 2 months of the study
Detailed Description:
The primary purpose of this study is to compare the relative safety and efficacy of risperidone and placebo in the treatment of children and adolescents with autistic disorder
HYPOTHESES 1 Risperidone will be more effective than placebo in reducing impulsive aggression agitation self-injurious behavior and troublesome repetitive behavior associated with autism 2 Risperidone will result in more sedation transient and weight gain than placebo 3 Patients continued on risperidone will be significantly less likely to experience exacerbation of symptoms of irritability aggression agitation and stereotypy than those randomized to placebo as measured by the Aberrant Behavior Checklist ABC the Ritvo-Freeman Real Life Rating Scale and the compulsions scale from the Childrens Yale-Brown Obsessive Compulsive Scale CY-BOCS 4 Patients continued on risperidone would show superior adjustment and functioning at the end of the trial as evidenced by lower Clinical Global Impression ratings when compared to patients randomized to placebo
Design Phase I Double-Blind Phase - Randomized double-blind placebo-controlled parallel groups design Eight-week double-blind treatment with risperidone or placebo Eight-week open trial with risperidone for placebo non-responders patients who were randomized to placebo and showed no improvement
Risperidone responders will be eligible to enter the four-month extension study Placebo responders and risperidone non-responders will be managed as clinically appropriate by each research site Phase II Extension Study - Four-month open treatment with risperidone Dose adjustment permitted according to clinical assessment efficacy or adverse events Two-month randomized double-blind placebo-controlled discontinuation parallel group design
Completers of four-month Extension Phase protocol who have maintained significantly improved status decrease greater than 25 in ABC from Protocol I Baseline ratings and CGI of much or very much improved will be randomized at the end of four months to placebo substitution or risperidone continuation Group assigned to placebo substitution will undergo weekly blinded reductions of entry dose dosage at end of Phase I by 25 per week over three consecutive weeks After full placebo substitution placebo group will remain on placebo for total of up to 5 weeks three-week taper five-week remaining on placebo Group assigned to continued active treatment will be maintained on entry dose level for full 8 weeks of Phase II assuming no behavioral deterioration Active treatment patients may have dose reduced for treatment emergent effects
Randomization - Balanced within site by Tanner Stage pre-pubertal Tanner I or II as measured by the absence of pubic hair post-pubertal Tanner III or greater gender and anticonvulsant use
HYPOTHESES 1 Risperidone will be more effective than placebo in reducing impulsive aggression agitation self-injurious behavior and troublesome repetitive behavior associated with autism 2 Risperidone will result in more sedation transient and weight gain than placebo 3 Patients continued on risperidone will be significantly less likely to experience exacerbation of symptoms of irritability aggression agitation and stereotypy than those randomized to placebo as measured by the Aberrant Behavior Checklist ABC the Ritvo-Freeman Real Life Rating Scale and the compulsions scale from the Childrens Yale-Brown Obsessive Compulsive Scale CY-BOCS 4 Patients continued on risperidone would show superior adjustment and functioning at the end of the trial as evidenced by lower Clinical Global Impression ratings when compared to patients randomized to placebo
Design Phase I Double-Blind Phase - Randomized double-blind placebo-controlled parallel groups design Eight-week double-blind treatment with risperidone or placebo Eight-week open trial with risperidone for placebo non-responders patients who were randomized to placebo and showed no improvement
Risperidone responders will be eligible to enter the four-month extension study Placebo responders and risperidone non-responders will be managed as clinically appropriate by each research site Phase II Extension Study - Four-month open treatment with risperidone Dose adjustment permitted according to clinical assessment efficacy or adverse events Two-month randomized double-blind placebo-controlled discontinuation parallel group design
Completers of four-month Extension Phase protocol who have maintained significantly improved status decrease greater than 25 in ABC from Protocol I Baseline ratings and CGI of much or very much improved will be randomized at the end of four months to placebo substitution or risperidone continuation Group assigned to placebo substitution will undergo weekly blinded reductions of entry dose dosage at end of Phase I by 25 per week over three consecutive weeks After full placebo substitution placebo group will remain on placebo for total of up to 5 weeks three-week taper five-week remaining on placebo Group assigned to continued active treatment will be maintained on entry dose level for full 8 weeks of Phase II assuming no behavioral deterioration Active treatment patients may have dose reduced for treatment emergent effects
Randomization - Balanced within site by Tanner Stage pre-pubertal Tanner I or II as measured by the absence of pubic hair post-pubertal Tanner III or greater gender and anticonvulsant use
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT | None | None | None |
| N01 MH70009 | None | None | None |
| N01 MH80011 | None | None | None |
| N01 MH70010 | None | None | None |
| N01 MH70001 | None | None | None |