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| ID | Type | Description | Link |
|---|---|---|---|
| K23MH081285 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Duke University | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable behaviors in autism spectrum disorders. All participants will receive active study medication. Participants will also receive diagnostic and cognitive evaluations at no cost. Participants will be required to undergo two fMRI (functional magnetic resonance imaging scans) where we will take pictures of your brain while performing simple tasks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-Label, Flexible-Dose Aripiprazole | Experimental | This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version | The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS-PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant. | Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose") |
| Measure | Description | Time Frame |
|---|---|---|
| Total Repetitive Behavior Scale - Revised (RBS_R) | The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales. The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linmarie Sikich, MD | University of North Carolina | Principal Investigator |
| Gabriel Dichter, PhD | University of North Carolina and Duke University | Principal Investigator |
| Cheryl O Alderman, BS | University of North Carolina, Chapel Hill | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States | ||
| Duke University Medical Center |
In order to participate in the research study, subjects must have been washed out from psychoactive medication for at least one month for fluoxetine, two weeks for other SSRIs and neuroleptics and five days for stimulants prior to MRI scanning, with the exception of stable doses greater than three months duration of medication for seizure disorder.
We planned to recruit participants through the NDRC Registry and Division TEACCH, as well as utilizing radio and television ads on various stations. We also posted brochures and flyers in public locations and attended conferences in order to hand out study-specific information. 13 subjects began the study and only one of those failed to complete.
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| ID | Title | Description |
|---|---|---|
| FG000 | Open-Label, Flexible-Dose Aripiprazole | This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks. Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open-Label, Flexible-Dose Aripiprazole | This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks. Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Total Repetitive Behavior Scale - Revised (RBS_R) | The RBS-R is an assessment that includes Sameness, Self-Injurious Behavior, Ritualistic, Compulsive, and Restrictive Behavior subscales. The assessments are completed by caregivers for the past week, with consideration of frequency,ease of redirecting and extent to which behavior interferes with functioning compared to a typically developing child of the same age and gender. Scores are rated from 0 - behavior does not occur to 3 - behavior occurs and is a serious problem. There are 43 items and 5 subscales. Higher scores indicate greater symptom severity. total score is the sum of all items in all subscales. The subscales are stereotyped behaviors 6 items, self-injurious behaviors 8 items, Compulsive behaviors- 8 items, Ritualistic Behaviors 6 items, Sameness 11 items, restricted behaviors 4 items.Total score ranges from 0 to 129. | All randomized participants' scores were analyzed using the RBS-R measure. Higher values reflect worse outcomes (greater symptom severity). Subscales are added to compute the total score. | Posted | Mean | Standard Deviation | units on a scale | baseline week 0, 8 weeks |
|
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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-Label, Flexible-Dose Aripiprazole | This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks. Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Social circumstances | Systematic Assessment |
The present study had 13 subjects. Due to sample size, analysis reflected an exploratory approach. If a mechanism for predicting RRB improvement is found in a study with a larger N, we could better understand therapies targeting core symptoms of ASD.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Linmarie Sikich, M.D. | The University of North Carolina at Chapel Hill | (919) 972-7499 | lsikich@med.unc.edu |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D003192 | Compulsive Behavior |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D007175 | Impulsive Behavior |
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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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| baseline week 0, 8 weeks |
| Durham |
| North Carolina |
| 27705 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose) | This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks. Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily |
| OG001 | Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose) | This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks. Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily |
|
|
| Primary | Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version | The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS-PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score > than 8 is considered clinically significant. | All randomized participants' scores were analyzed using the PDD-CYBOCS measure. Higher values reflect worse outcomes. Subscales are added to compute the total score (total score does not include compulsion free-interval and peculiarity of the behavior. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose") |
|
|
|
| 0 |
| 13 |
| 13 |
| 13 |
| Body Pain | General disorders | Systematic Assessment |
|
| Depressed Mood | Psychiatric disorders | Systematic Assessment |
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| Drowsiness | General disorders | Systematic Assessment |
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| Dry Mouth | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Increased Appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Increased Sleep | General disorders | Systematic Assessment |
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| Nausea | General disorders | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
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| Restlessness | General disorders | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
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| Tremors | Nervous system disorders | Systematic Assessment |
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| Urination | Renal and urinary disorders | Systematic Assessment |
|
| Weight Gain | Metabolism and nutrition disorders | Systematic Assessment |
|
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| D001519 | Behavior |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |