Autistic DisorderPhase 2PAIRSNCT00619190
Study of Aripiprazole to Treat Children and Adolescents With Autism
A Phase 2 study testing aripiprazole in people with Autistic Disorder and Asperger Syndrome, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders. Read more about this study
- Who is it for?
- Ages 30 months to 17 years
- Conditions the study is for
- Autistic Disorder, Asperger Syndrome, Autism Spectrum Disorder
- What is being tested?
- aripiprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level
- Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation Scale (ADOS)
- Have a guardian who is able and willing to give written informed consent
- If competent, subject able and willing to give written assent for their own participation
- If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months
- Subjects may receive other nonpharmacologic treatment including dietary treatments
Who cannot join
- Diagnosis of Rett's syndrome or Child Disintegrative Disorder
- Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks
- Previous trial of aripiprazole
- Pregnant or nursing
- Epilepsy or another significant chronic medical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina, Department of Psychiatry
Chapel Hill, North Carolina, 27514
About this study
Official title: An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders
The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.
Read the detailed description
The purpose of this open label study in children and adolescents with autism spectrum disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behaviors associated with ASD and development in three behavioral domains which appear particularly affected by ASD. We are also examining the safety and tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled in the treatment part of the study. An additional 10 children, self selected by guardian desire not to pursue pharmacological treatment, will serve as a nonrandomized control group. This group will be provided with support but not any other treatments, come in for fewer visits and will be asked not to seek pharmacologic treatment outside the study. As of January 2010, we have completed enrollment in the treatment arm. Currently, we are only looking to enroll individuals in the control arm in which participants would not take any psychiatric medication.
- Being tested
- aripiprazole
- Keywords
- open label, aripiprazole, children, adolescents, autism spectrum disorders
- Medical subject headings
- Autistic Disorder, Asperger Syndrome, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
Also called Abilify
aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months
| Study group | Role | What they receive |
|---|---|---|
| open aripipraprazole | Experimental | Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg Receives: Drug: aripiprazole |
| no medication control | No intervention | group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks
The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant.
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Clinical Global Impressions Scale - Severity Score (CGI-S)
One of the most widely used of clinician assessment tools in psychiatry, the CGI is an observer-rated scale that measures illness severity (CGI-S).
The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (among the most severely ill patients).
Measured: Baseline to 12 weeks
Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks
The Aberrant Behavior Checklist lethargy/social withdrawal subscale (ABC-SW) is the sum of ratings from 0 - not a problem at all to 3 - problem is severe in degree on 16 items within the Aberrant Behavior checklist (also described in the primary outcome measure section above). Scores can range from 0 to 48, with higher scores indicating more severe problems. The period for the rating is one week and the reference group is typically developing children of the same age and gender as the participant. Both frequency of the behaviors and severity of the problems related to them are considered. High ratings on these items reflect lack of response and interaction with other people in the child's environment.
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Linmarie Sikich, MD, University of North Carolina, Chapel Hill
- Investigators
- Linmarie Sikich, MD, Principal investigator, University of North Carolina, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00619190
- Sponsor's protocol ID
- 04-1792 GCRC-2491
- Acronym
- PAIRS
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2008
- Last updated
- 26 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of Aripiprazole in Children and Adolescents With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT00619190
- Acronym / sponsor ID
- PAIRS / 04-1792 GCRC-2491
- Keywords
- open label, aripiprazole, children, adolescents, autism spectrum disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Jan 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 26 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this open label study in children and adolescents is to examine the acute and long-term effects of aripiprazole on problem behaviors associated with autism spectrum disorders and development in areas which appear to be affected by autism spectrum disorders.
Detailed description
The purpose of this open label study in children and adolescents with autism spectrum disorders (ASD) is to examine the acute (12 week) and long-term (1 year) effects of aripiprazole on problem behaviors associated with ASD and development in three behavioral domains which appear particularly affected by ASD. We are also examining the safety and tolerability of aripiprazole in a range of children with autism. 20 children will be enrolled in the treatment part of the study. An additional 10 children, self selected by guardian desire not to pursue pharmacological treatment, will serve as a nonrandomized control group. This group will be provided with support but not any other treatments, come in for fewer visits and will be asked not to seek pharmacologic treatment outside the study. As of January 2010, we have completed enrollment in the treatment arm. Currently, we are only looking to enroll individuals in the control arm in which participants would not take any psychiatric medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open aripipraprazole | Experimental | Drug: aripiprazoleOpenly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg |
| no medication control | No intervention | –group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. |
Who may qualify
- Ages
- 30 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Subjects must be between 30 months and 17 years 11 months, male or female, of any ethnicity and of any cognitive level
- Meet criteria for diagnosis of autism, Asperger's Disorder or Pervasive Developmental Order NOS (i.e. an autism spectrum disorder) based on clinical evaluation and either the Autism Diagnostic Interview - Revised (ADI-R) or the Autism Diagnostic Observation Scale (ADOS)
- Have a guardian who is able and willing to give written informed consent
- If competent, subject able and willing to give written assent for their own participation
- If on anticonvulsants, subject have been seizure-free and on a stable anticonvulsant regimen for at least 6 months
Key exclusion criteria (5 listed)
- Diagnosis of Rett's syndrome or Child Disintegrative Disorder
- Taken psychotropic medications other than clonidine or diphenhydramine within 2 weeks
- Previous trial of aripiprazole
- Pregnant or nursing
- Epilepsy or another significant chronic medical illness
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 |
|---|---|---|
| aripiprazoleAlso: Abilifyaripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months | Drug | open aripipraprazole |
Primary outcome
Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks
Time frame: Baseline to 12 weeks
The Aberrant Behavior Checklist (ABC) is a caregiver rated questionnaire for assessing problem behaviors of children over the past week relative to typically developing children of the same age. Problem behaviors are rated on a categorical scale between 0 not at all a problem and 3 problem is severe in degree. Raters are instructed to consider both the severity and the frequency of the behavior in determining how severe a problem the behavior is. Thus, if a given behavior occurs more often than in other children of the same age and sex, scores greater than or equal to 1 are warranted. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, higher the number the worse the symptoms.The irritability subscale consists of 15 items with a minimal score of 0 - no irritability problems to 45 - all irritability items rated as severe. A rating of 18 or more on the irritability subscale is considered clinically significant.
2 secondary outcomes
Clinical Global Impressions Scale - Severity Score (CGI-S)
Time frame: Baseline to 12 weeks
Change From Baseline in the Aberrant Behavior Checklist -Lethargy/Social Withdrawal Subscale at 12 Weeks
Time frame: Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Linmarie Sikich, MD principal investigator
University of North Carolina, Department of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing aripiprazole in people with Autistic Disorder and Asperger Syndrome, run by University of North Carolina, Chapel Hill 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 5 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 26 Mar 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Change From Baseline in Aberrant Behavior Checklist-Irritability at 12 Weeks (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2014.