Mental RetardationPhase 3NCT00065273
Atypical Neuroleptic Drugs in People With Mental Retardation/Developmental Delay
A Phase 3 study testing risperidone, clozapine and olanzapine in people with Mental Retardation and Developmental Delay Disorder, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
Psychiatric drugs are often used to treat behavioral symptoms of mental retardation/developmental delay (MR/DD). These drugs can cause serious side effects. Newer drugs may have decreased side effects. This study will compare new and old drugs used to treat behavioral symptoms in people with MR/DD. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Mental Retardation, Developmental Delay Disorder
- What is being tested?
- risperidone, clozapine and olanzapine
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to Jun 2001
- Phase
- Phase 3
- 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 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primary diagnosis of mental retardation (IQ < 70)
- Scheduled for medication reductions from psychotropic drugs and subsequent placement on risperidone
- Severe self-injury, aggression, property destruction, or stereotypic behavior for 6 months prior to study entry
- No seizures, or seizures under control of medication for previous 2 years
- Additional Inclusion Criteria for Substudy
- Participants in the primary study who are available for 2 hour weekly or bi-weekly clinic visits and are able to have observers in their home, school, and/or work environment
Who cannot join
- Degenerative disease that may affect motor or cognitive functioning
- Progressive disease of an organ system
- Advanced age that may produce deteriorating cognitive or motor functioning
- Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Severe Aberrant Behavior Among Persons With Mental Retardation. Project III: Behavioral Selectivity of Atypical Neuroleptic Drugs: Effects on Cognitive and Social Behaviors
Psychiatric drugs are often used to treat behavioral symptoms of mental retardation/developmental delay (MR/DD). These drugs can cause serious side effects. Newer drugs may have decreased side effects. This study will compare new and old drugs used to treat behavioral symptoms in people with MR/DD.
Read the detailed description
Atypical neuroleptics have fewer extrapyramidal and behavioral side effects than typical neuroleptics. Atypical neuroleptics may also improve social and cognitive functioning. This improvement may be due to reductions in the negative symptoms that are part of the psychosis and psychiatric syndromes or to the improved side effect profile. This study will examine the effects of the atypical neuroleptic drugs risperidone, clozapine, and olanzapine on learning, memory, and social behavior in individuals with MR/DD. A substudy will expand the study to evaluate ecobehavioral measures. The goal of these studies is to assess the behavioral selectivity of atypical neuroleptics by measuring cognitive and social functioning along with targeted aberrant behaviors in individuals under placebo and different doses of drug.
Fifty participants will be randomized to receive risperidone, clozapine, olanzapine, or placebo. Twenty-five of the participants will be drawn from a group receiving typical neuroleptics at the onset of the study. The efficacy of atypical neuroleptics in reducing destructive, aggressive, and stereotypic behaviors in persons with mental retardation will be assessed.
Learning and memory will be measured using laboratory operant tasks. Social and environmental interactions, as well as primary target behaviors, will be directly measured by trained observers. The frequency of specific aberrant behaviors will be determined, along with the conditional probabilities that certain environmental events proceed and follow these behaviors. In the substudy, categories of aberrant behavior will be used to provide information relevant to environmental variables maintaining aberrant behavior; this categorization will improve the determinations of pharmacologic efficacy and will provide a better understanding of the relationship between atypical neuroleptics and environmentally maintained aberrant behavior.
- Conditions
- Mental Retardation, Developmental Delay Disorder
- Being tested
- risperidone, clozapine, olanzapine
- Keywords
- Severe aberrant behavior, Risperidone, Clozapine, Haloperidol, Laboratory operant tasks, Simple acquisition procedures, Matching to sample task, Lag sequential analysis
- Medical subject headings
- Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
clozapineDrug
olanzapineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2003 (estimated)
- Study startJul 1998
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mental RetardationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Stephen Schroeder, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065273
- Sponsor's protocol ID
- 5P01HD026927
- Other IDs
- 5P01HD026927
- Status last verified
- Jun 2003
- First submitted
- 21 Jul 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Valdovinos MG, Napolitano DA, Zarcone JR, Hellings JA, Williams DC, Schroeder SR. Multimodal evaluation of risperidone for destructive behavior: functional analysis, direct observations, rating scales, and psychiatric impressions. Exp Clin Psychopharmacol. 2002 Aug;10(3):268-75. doi: 10.1037//1064-1297.10.3.268.
PubMed 12233987McAdam DB, Zarcone JR, Hellings J, Napolitano DA, Schroeder SR. Effects of risperidone on aberrant behavior in persons with developmental disabilities: II. Social validity measures. Am J Ment Retard. 2002 Jul;107(4):261-9. doi: 10.1352/0895-8017(2002)1072.0.CO;2.
PubMed 12069645Zarcone JR, Hellings JA, Crandall K, Reese RM, Marquis J, Fleming K, Shores R, Williams D, Schroeder SR. Effects of risperidone on aberrant behavior of persons with developmental disabilities: I. A double-blind crossover study using multiple measures. Am J Ment Retard. 2001 Nov;106(6):525-38. doi: 10.1352/0895-8017(2001)1062.0.CO;2.
PubMed 11708938Hellings JA, Zarcone JR, Crandall K, Wallace D, Schroeder SR. Weight gain in a controlled study of risperidone in children, adolescents and adults with mental retardation and autism. J Child Adolesc Psychopharmacol. 2001 Fall;11(3):229-38. doi: 10.1089/10445460152595559.
PubMed 11642473Hammock R, Levine WR, Schroeder SR. Brief report: effects of clozapine on self-injurious behavior of two risperidone nonresponders with mental retardation. J Autism Dev Disord. 2001 Feb;31(1):109-13. doi: 10.1023/a:1005626100084.
PubMed 11439749
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Aberrant Behavior Among Persons With Mental Retardation. Project III: Behavioral Selectivity of Atypical Neuroleptic Drugs: Effects on Cognitive and Social Behaviors
- ClinicalTrials.gov ID
- NCT00065273
- Acronym / sponsor ID
- 5P01HD026927
- Conditions
- Mental Retardation, Developmental Delay Disorder
- Keywords
- Severe aberrant behavior, Risperidone, Clozapine, Haloperidol, Laboratory operant tasks, Simple acquisition procedures, Matching to sample task, Lag sequential analysis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jul 1998
- Study completion
- Jun 2001
- First posted
- 22 Jul 2003 (estimated)
- 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.
Psychiatric drugs are often used to treat behavioral symptoms of mental retardation/developmental delay (MR/DD). These drugs can cause serious side effects. Newer drugs may have decreased side effects. This study will compare new and old drugs used to treat behavioral symptoms in people with MR/DD.
Detailed description
Atypical neuroleptics have fewer extrapyramidal and behavioral side effects than typical neuroleptics. Atypical neuroleptics may also improve social and cognitive functioning. This improvement may be due to reductions in the negative symptoms that are part of the psychosis and psychiatric syndromes or to the improved side effect profile. This study will examine the effects of the atypical neuroleptic drugs risperidone, clozapine, and olanzapine on learning, memory, and social behavior in individuals with MR/DD. A substudy will expand the study to evaluate ecobehavioral measures. The goal of these studies is to assess the behavioral selectivity of atypical neuroleptics by measuring cognitive and social functioning along with targeted aberrant behaviors in individuals under placebo and different doses of drug.
Fifty participants will be randomized to receive risperidone, clozapine, olanzapine, or placebo. Twenty-five of the participants will be drawn from a group receiving typical neuroleptics at the onset of the study. The efficacy of atypical neuroleptics in reducing destructive, aggressive, and stereotypic behaviors in persons with mental retardation will be assessed.
Learning and memory will be measured using laboratory operant tasks. Social and environmental interactions, as well as primary target behaviors, will be directly measured by trained observers. The frequency of specific aberrant behaviors will be determined, along with the conditional probabilities that certain environmental events proceed and follow these behaviors. In the substudy, categories of aberrant behavior will be used to provide information relevant to environmental variables maintaining aberrant behavior; this categorization will improve the determinations of pharmacologic efficacy and will provide a better understanding of the relationship between atypical neuroleptics and environmentally maintained aberrant behavior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Primary diagnosis of mental retardation (IQ < 70)
- Scheduled for medication reductions from psychotropic drugs and subsequent placement on risperidone
- Severe self-injury, aggression, property destruction, or stereotypic behavior for 6 months prior to study entry
- No seizures, or seizures under control of medication for previous 2 years
- Additional Inclusion Criteria for Substudy
Key exclusion criteria (4 listed)
- Degenerative disease that may affect motor or cognitive functioning
- Progressive disease of an organ system
- Advanced age that may produce deteriorating cognitive or motor functioning
- Multiple sensory or motor disabilities that will interfere with seeing the stimuli and responding to the computer
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 |
|---|---|---|
| risperidone | Drug | – |
| clozapine | Drug | – |
| olanzapine | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Jun 2005.
- Background: PubMed 12233987Valdovinos MG, Napolitano DA, Zarcone JR, Hellings JA, Williams DC, Schroeder SR. Multimodal evaluation of risperidone for destructive behavior: functional analysis, direct observations, rating scales, and psychiatric impressions. Exp Clin Psychopharmacol. 2002 Aug;10(3):268-75. doi: 10.1037//1064-1297.10.3.268.
- Background: PubMed 12069645McAdam DB, Zarcone JR, Hellings J, Napolitano DA, Schroeder SR. Effects of risperidone on aberrant behavior in persons with developmental disabilities: II. Social validity measures. Am J Ment Retard. 2002 Jul;107(4):261-9. doi: 10.1352/0895-8017(2002)1072.0.CO;2.
- Background: PubMed 11708938Zarcone JR, Hellings JA, Crandall K, Reese RM, Marquis J, Fleming K, Shores R, Williams D, Schroeder SR. Effects of risperidone on aberrant behavior of persons with developmental disabilities: I. A double-blind crossover study using multiple measures. Am J Ment Retard. 2001 Nov;106(6):525-38. doi: 10.1352/0895-8017(2001)1062.0.CO;2.
- Background: PubMed 11642473Hellings JA, Zarcone JR, Crandall K, Wallace D, Schroeder SR. Weight gain in a controlled study of risperidone in children, adolescents and adults with mental retardation and autism. J Child Adolesc Psychopharmacol. 2001 Fall;11(3):229-38. doi: 10.1089/10445460152595559.
- Background: PubMed 11439749Hammock R, Levine WR, Schroeder SR. Brief report: effects of clozapine on self-injurious behavior of two risperidone nonresponders with mental retardation. J Autism Dev Disord. 2001 Feb;31(1):109-13. doi: 10.1023/a:1005626100084.
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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.
Stephen Schroeder, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing risperidone, clozapine and olanzapine in people with Mental Retardation and Developmental Delay Disorder, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site 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 6 inclusion and 4 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 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00065273, which also lists 5 linked publications.
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 24 Jun 2005.