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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open aripipraprazole | Experimental | Openly 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aripiprazole | Drug | aripiprazole, open label, flexibly dosed from 1mg to 30mg, provided for up to 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linmarie Sikich, MD | University of North Carolina, Department of Psychiatry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina, Department of Psychiatry | Chapel Hill | North Carolina | 27514 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Aripipraprazole | Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg |
| FG001 | no Medication Control | group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Aripipraprazole | Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg |
| BG001 | no Medication Control | group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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). | Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
Adverse event data was collected from baseline to 12 weeks treatment. It was a systematic assessment of adverse effects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open Aripipraprazole | Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agitation | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linmarie Sikich, MD | UNC Chapel Hill | 919-972-7499 | lsikich@med.unc.edu |
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| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D020817 | Asperger Syndrome |
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
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| 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. | Baseline to 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions |
|
|
| Primary | 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. | Only 20 out of 21 total participants were analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
| Secondary | 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. | Only 20 out of 21 total participants was analyzed in the aripriprazole group because one participant dropped out before 12 weeks and so the data was not available. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 12 weeks |
|
|
|
| 0 |
| 21 |
| 19 |
| 21 |
| EG001 | no Medication Control | group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions | 0 | 9 | 5 | 9 |
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Appetite Increased | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Appetite Decreased | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Insomnia | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Encopresis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Fever | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Nightmares | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache/Migraine | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Allergies | Immune system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Mouth Sores | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| acne | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |