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| Name | Class |
|---|---|
| Otsuka America Pharmaceutical | INDUSTRY |
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This study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (AD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 | Experimental | 5 mg |
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| A2 | Experimental | 10 mg |
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| A3 | Experimental | 15 mg |
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| B1 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aripiprazole | Drug | Tablets, Oral, once daily, 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score | The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Clinical Global Impressions Improvement Scale (CGI-I) Score | The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Alabama At Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Harmonex Neuroscience |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19797985 | Background | Marcus RN, Owen R, Kamen L, Manos G, McQuade RD, Carson WH, Aman MG. A placebo-controlled, fixed-dose study of aripiprazole in children and adolescents with irritability associated with autistic disorder. J Am Acad Child Adolesc Psychiatry. 2009 Nov;48(11):1110-1119. doi: 10.1097/CHI.0b013e3181b76658. | |
| 24138011 | Derived |
| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | |
| FG001 | Aripiprazole 5 mg | |
| FG002 | Aripiprazole 10 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Tablets, Oral, once daily, 8 weeks |
|
| Week 8 |
| Number of Participants With Response at Week 8 | Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint. | Week 8 |
| Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) | CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement. | Week 8 |
| Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores | Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement. | Week 8 |
| Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) | A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement. | Week 8 |
| Summary of Safety | Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation | continuously throughout the study |
| Change From Baseline in Body Weight | Adjusted mean change (Week 8 - baseline) in body weight | Week 8 |
| Dothan |
| Alabama |
| 36303 |
| United States |
| Southwest Autism Research And Resource Center | Phoenix | Arizona | 85006 | United States |
| Clinical Innovations, Inc. | Huntington Beach | California | 92647 | United States |
| University Of California-Davis Medical Center | Sacramento | California | 95817 | United States |
| Stanford University School Of Medicine | Stanford | California | 94305 | United States |
| The Children'S Hospital | Aurora | Colorado | 80045 | United States |
| Marsella, Gregory | Boca Raton | Florida | 33432 | United States |
| University Of Florida | Gainesville | Florida | 32611 | United States |
| University Of South Florida | Tampa | Florida | 33613 | United States |
| Institute For Behavioral Medicine | Smyrna | Georgia | 30080 | United States |
| University Of Illinois At Chicago | Chicago | Illinois | 60606 | United States |
| Cambridge Health Alliance | Medford | Massachusetts | 02139 | United States |
| Ladders Clinic | Wellesley | Massachusetts | 02481 | United States |
| Children'S Hospital Of Michigan | Detroit | Michigan | 48201 | United States |
| Regions Hospital | Saint Paul | Minnesota | 55101 | United States |
| Children'S Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| Munroe-Meyer Institute | Omaha | Nebraska | 68198 | United States |
| North Shore - Long Island Jewish Health System | Bethpage | New York | 11714 | United States |
| Seaver And New York Autism Center Of Excellence | New York | New York | 10029 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Mission Hospitals | Asheville | North Carolina | 28801 | United States |
| Duke Child And Family Study Center | Durham | North Carolina | 27710 | United States |
| The Nisonger Center | Columbus | Ohio | 43210 | United States |
| Cutting Edge Research | Oklahoma City | Oklahoma | 73116 | United States |
| Western Psychiatric Institute And Clinic | Pittsburgh | Pennsylvania | 15203 | United States |
| Dallas Pediatric Neurology Associates | Dallas | Texas | 75230 | United States |
| Bayou City Research, Ltd. | Houston | Texas | 77007 | United States |
| Children'S National Medical Center | Fairfax | Virginia | 22031 | United States |
| Pacific Institute Of Medical Sciences | Bothell | Washington | 98011 | United States |
| Children'S Hospital Of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| Mankoski R, Stockton G, Manos G, Marler S, McQuade R, Forbes RA, Marcus R. Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure, adverse events, and weight change. J Child Adolesc Psychopharmacol. 2013 Oct;23(8):572-6. doi: 10.1089/cap.2012.0075. |
| 21731831 | Derived | Robb AS, Andersson C, Bellocchio EE, Manos G, Rojas-Fernandez C, Mathew S, Marcus R, Owen R, Mankoski R. Safety and tolerability of aripiprazole in the treatment of irritability associated with autistic disorder in pediatric subjects (6-17 years old):results from a pooled analysis of 2 studies. Prim Care Companion CNS Disord. 2011;13(1):PCC.10m01008. doi: 10.4088/PCC.10m01008gry. |
| Otsuka Clinical Trial Transparency | View source |
| FG003 | Aripiprazole 15 mg |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | Aripiprazole 5 mg | |
| BG002 | Aripiprazole 10 mg | |
| BG003 | Aripiprazole 15 mg | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race, Customized | Number | participants |
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| Ethnicity, Customized | Number | Participants |
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| Weight Group | Number | Participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| Height | Mean | Standard Deviation | centimeters |
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| Weight | Mean | Standard Deviation | kilograms |
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| 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 | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change (Week 8 - Baseline) in the Autistic Behavior Checklist (ABC) Irritability Subscale Score | The ABC is a 58-item informant-based assessment of problem behaviors in children/adolescents with mental retardation. Items are rated on a 4-point scale (0=no problem, 3=severe problem), and resolve into 5 domain subscales. A decrease in score indicates improvement. | Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF. | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Mean Clinical Global Impressions Improvement Scale (CGI-I) Score | The CGI scale is a clinician-rated global assessment of a patient's improvement over time. Baseline assessment rated a patient's condition on a 7-point scale (1=no symptoms, 7=very severe symptoms). Subsequent assessed improvement relative to baseline symptoms on a 7-point CGI-I item scale (1=very much improved, 7=very much worse). | Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF. | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Number of Participants With Response at Week 8 | Response defined as a ≥ 25% reduction from baseline to endpoint in the ABC Irritability Subscale score and a CGI-I score of 1 or 2 at endpoint. | Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF. | Posted | Number | Participants | Week 8 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change (Week 8 - Baseline) in the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Compulsion Scale Only) | CY-BOCS=10-item assessment of obsessive-compulsive symptoms in patients <18 years. 5 items pertaining to compulsions rate symptoms (time spent, interference with functioning, distress, resistance, control) on a 5-point scale (0=no symptoms/minimum severity, 4=extreme symptoms/maximum severity). A decreased in value indicates improvement. | Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF. | Posted | Mean | Standard Error | units on a scale | Week 8 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change (Week 8 - Baseline) in the Other ABC Subscale Scores | Mean change (Week 8 - baseline) in the other ABC subscale scores (lethargy/social withdrawal; stereotypic behavior; hyperactivity/ noncompliance; inappropriate speech). A decrease in value indicates improvement. | Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF. | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Mean Change (Week 8 - Baseline) in CGI-Severity (CGI-S) | A CGI-S assessment (a 7-point scale to evaluate the severity of symptoms) was performed at baseline (1=no symptoms; 7=very severe symptoms). The patient's improvement relative to the symptoms at baseline on were assessed on a 7-point CGI-I (1=very much improved; 7=very much worse). A decrease in value indicates improvement. | Efficacy population=all randomized participants minus 3 patients in the placebo group (1 lost to follow-up, 1 withdrew consent, 1 no longer met study criteria), 1 participant in the 5-mg group who withdrew consent, and 1 participant in the 15-mg group who had elevated potassium levels. Data set is LOCF. | Posted | Mean | Standard Error | units on a scale | Week 8 |
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| Secondary | Summary of Safety | Deaths, Adverse Events (AEs), Serious AEs (SAEs), Treatment-Emergent AEs and AEs leading to discontinuation | Safety population=all randomized participants minus 1 patients in the placebo group (no longer met study criteria), and 1 participant in the 5-mg group who withdrew consent. | Posted | Number | participants | continuously throughout the study |
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| Secondary | Change From Baseline in Body Weight | Adjusted mean change (Week 8 - baseline) in body weight | Safety population=all randomized participants minus 3 patients in the placebo group (1 no longer met study criteria, 2 did not have measurement at baseline and Week 8), and 1 participant in the 5-mg group who withdrew consent. Data set is LOCF. | Posted | Mean | Standard Error | kilograms | Week 8 |
|
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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 | Aripiprazole 10 mg | 1 | 59 | 51 | 59 | |||
| EG001 | Aripiprazole 15 mg | 0 | 54 | 42 | 54 | |||
| EG002 | Aripiprazole 5 mg | 1 | 52 | 37 | 52 | |||
| EG003 | Placebo | 0 | 51 | 31 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AGGRESSION | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| PRESYNCOPE | Nervous system disorders | MedDRA 11 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| WEIGHT INCREASED | Investigations | MedDRA 11 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
| |
| AGGRESSION | Psychiatric disorders | MedDRA 11 | Systematic Assessment |
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| SEASONAL ALLERGY | Immune system disorders | MedDRA 11 | Systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| DROOLING | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| LETHARGY | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| SEDATION | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| AKATHISIA | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| HYPERSOMNIA | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| EXTRAPYRAMIDAL DISORDER | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| PSYCHOMOTOR HYPERACTIVITY | Nervous system disorders | MedDRA 11 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
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| SALIVARY HYPERSECRETION | Gastrointestinal disorders | MedDRA 11 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 11 | Systematic Assessment |
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| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 11 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 11 | Systematic Assessment |
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| ENURESIS | Renal and urinary disorders | MedDRA 11 | Systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
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| INCREASED APPETITE | Metabolism and nutrition disorders | MedDRA 11 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 11 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
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| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 11 | Systematic Assessment |
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| THIRST | General disorders | MedDRA 11 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 11 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 11 | Systematic Assessment |
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Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Transparency | Otsuka | 1-800-441-6773 | SMB_ClinicalTranspa@otsuka-us.com |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D000067877 | Autism Spectrum Disorder |
| 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 |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 13 to 17 years |
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| Male |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Other |
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| Not Hispanic/Latino |
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| ≥40 kilograms |
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| Participants |
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