Trial · NCT00365859
Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
NCT00365859, Phase 3, Completed, Otsuka Pharmaceutical Development & Commercialization, Inc.; results first posted 2010-01-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD). Trials, record NCT00365859. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00365859
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Aripiprazole in the Treatment of Serious Behavioral Problems in Children and Adolescents With Autistic Disorder (AD)
- NCT number
- NCT00365859
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 330 participants, actual
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Conditions
- Autistic Disorder, Behavioral Symptoms
- Interventions
- Aripiprazole
- First posted
- 2006-08-18
- Last updated
- 2026-08-04
- Results first posted
- 2010-01-25
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs | Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Primary | Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52 | Baseline, Week 8, Week 26, Week 52 | The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50. Negative change scores indicate improvement. |
| Primary | Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52 | Baseline, Week 8, Week 26, Week 52 | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. |
| Primary | Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint | Baseline, Week 8, Week 26, Week 52 | The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. |
| Primary | Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 | Abnormal metabolic criterion values include the following: fasting serum glucose ≥115 mg/dL; non-fasting serum glucose ≥ 200 mg/dL; total cholesterol ≥240 mg/dL; LDL cholesterol ≥160 mg/dL; HDL cholesterol ≤30 mg/dL; triglycerides ≥120 mg/dL (females), ≥160 mg/dL (males) |
| Primary | Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 | Abnormal hematology criterion values include the following: hematocrit (ages 6-17, males \& females) ≤33%; hemoglobin (ages 6-17, males \& females) \<11.3 g/dL; leukocytes ≤2800 c/mm3 or ≥16000 c/mm3; eosinophils (ages 6-17, males \& females) \>17%; neutrophils \<15%; platelet count ≤75,000 c/mm3 or ≥700,000 c/mm3 |
| Primary | Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 | Abnormal chemistry criterion values include the following: aspartate aminotransferase ≥3x upper limit of normal (ULN); alanine aminotransferase ≥3x ULN; alkaline phosphatase ≥3x ULN; lactate dehydrogenase ≥3x ULN; creatinine ≥2.0 mg/dL; uric acid, ≥10.5 mg/dL (male), ≥8.5 mg/dL (female); bilirubin (Total) ≥2.0 mg/dL; serum prolactin \>ULN; creatine kinase ≥3x ULN; blood urea nitrogen ≥30 mg/dL; sodium ≤126 mEq/L or ≥156 mEq/L; potassium ≤2.5 mEq/L or ≥ 6.5 mEq/L; chloride ≤90 mEq/L or ≥118 mEq/L; calcium ≤8.2 mg/dL or ≥12 mg/dL |
| Primary | Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 | These abbreviations are used in the table of ECG measurements: supraventricular (SV), baseline (BL), 1 degree (1°), atrioventricular (A-V), intraventricular (IVT), symmetrical (SYM), corrected QT interval (QTc). QRS complex is a recording of a single heartbeat on ECG corresponding to the depolarization of the right and left ventricles. PR interval is measured from beginning of P wave to beginning of QRS complex. QT interval is a measure of time between start of Q wave and end of T wave in the heart's electrical cycle. ↑ = increase from baseline, ↓ = decrease from baseline, → = "to" |
| Primary | Number of Potentially Clinically Relevant Vital Sign Abnormalities | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) | Clinically significantly abnormal vital signs met age-appropriate (heart rate cohorts: ages 5-14 \& ages 15+; blood pressure cohorts: ages 6-12 \& ages 13-17) criterion AND represented change from pretreatment value of at least the following magnitudes: systolic blood pressure (≥130 mmHg \& ≥144 mmHg w/ increase of ≥20 mmHg) or (≤117 mmHg \& ≤120 mmHg w/ decrease of ≥20 mmHg); diastolic blood pressure (≥86 mmHg \& ≥92 mmHg w/ increase of ≥15 mmHg) or (≤75 mm Hg \& ≤80 mmHg w/ decrease of ≥15 mmHg); heart rate (140 bpm and 120 bpm w/ increase of ≥15 bpm) or (50 bpm and 50 bpm w/ decrease of ≥15 bpm). |
| Primary | Mean Change From Baseline in Patient Weight | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | From Screening (up to 42 days prior to treatment start) through Week 52 (end of study) for SAEs; from Week 0 (Baseline) through Week 52 (End of Study) for AEs | Safety Population | Participants | NUMBER |
| PRIMARY | Mean Change From Baseline in Total Simpson-Angus Scale (SAS) At Week 8, Week 26, and Week 52 | Baseline, Week 8, Week 26, Week 52 | Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF) | units on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) At Week 8, Week 26, and Week 52 | Baseline, Week 8, Week 26, Week 52 | Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF) | units on a scale | MEAN |
| PRIMARY | Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Week 8, Week 26, Week 52, and Endpoint | Baseline, Week 8, Week 26, Week 52 | Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF) | units on a scale | MEAN |
| PRIMARY | Number of Participants With Potentially Clinically Relevant Laboratory Metabolic Abnormalities | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 | Safety Sample | Participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Relevant Laboratory Hematology Abnormalities | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 | Safety Sample | Participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Relevant Laboratory Chemistry Abnormalities | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 | Safety Sample | Participants | NUMBER |
| PRIMARY | Number of Participants With Potentially Clinically Relevant Eletrocardiograph (ECG) Abnormalities | At screening (up to 42 days prior to treatment start), Week 8, Week 26, Week 52 | Safety Sample | Participants | NUMBER |
| PRIMARY | Number of Potentially Clinically Relevant Vital Sign Abnormalities | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) | Safety Sample | Participants | NUMBER |
| PRIMARY | Mean Change From Baseline in Patient Weight | At screening (up to 42 days prior to treatment start), Week 0 (Baseline), Week 1, Week 2, Week 4, Week 8, Week 14, Week 20, Week 26, Week 34, Week 42, Week 52 (Endpoint) | Safety Sample - Observed Cases (OC) Data Set and Endpoint - Last Observation Carried Forward (LOCF) | kg | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group532
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | De Novo | Deaths | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Rollover Placebo | Deaths | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Rollover Aripiprazole | Deaths | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Total | Deaths | 0 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | De Novo | Treatment-Emergent SAEs | 3 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Rollover Placebo | Treatment-Emergent SAEs | 1 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Rollover Aripiprazole | Treatment-Emergent SAEs | 5 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Total | Treatment-Emergent SAEs | 9 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | De Novo | Treatment-Emergent AEs | 75 | Participants | |
| Number of Participants With Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events (AEs), Deaths, AEs Leading to Discontinuation, Extra Pyramidal Syndrome (EPS)-Related AEs | Rollover Placebo | Treatment-Emergent AEs | 63 | Participants |
1 to 10 of 532Source ClinicalTrials.gov
See all 532 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | De Novo | 86 | |
| Overall Study | STARTED | Rollover Placebo | 70 | |
| Overall Study | STARTED | Rollover Aripiprazole | 174 | |
| Overall Study | STARTED | Total | 330 | |
| Overall Study | Safety Population | De Novo | 86 | |
| Overall Study | Safety Population | Rollover Placebo | 70 | |
| Overall Study | Safety Population | Rollover Aripiprazole | 174 | |
| Overall Study | Safety Population | Total | 330 | |
| Overall Study | Efficacy Population | De Novo | 84 | |
| Overall Study | Efficacy Population | Rollover Placebo | 69 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | WEIGHT INCREASED | Investigations | De Novo | 20 | 86 | |
| other | WEIGHT INCREASED | Investigations | Roll Over Aripiprazole | 40 | 174 | |
| other | WEIGHT INCREASED | Investigations | Roll Over Placebo | 16 | 70 | |
| other | TIC | Psychiatric disorders | De Novo | 0 | 86 | |
| other | TIC | Psychiatric disorders | Roll Over Aripiprazole | 2 | 174 | |
| other | TIC | Psychiatric disorders | Roll Over Placebo | 6 | 70 | |
| other | ANXIETY | Psychiatric disorders | De Novo | 3 | 86 | |
| other | ANXIETY | Psychiatric disorders | Roll Over Aripiprazole | 10 | 174 | |
| other | ANXIETY | Psychiatric disorders | Roll Over Placebo | 0 | 70 | |
| other | INSOMNIA | Psychiatric disorders | De Novo | 8 | 86 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | De Novo | ||
| Total, all-cause mortality | Roll Over Aripiprazole | ||
| Total, all-cause mortality | Roll Over Placebo | ||
| Total, other adverse events | De Novo | 73 | 86 |
| Total, other adverse events | Roll Over Aripiprazole | 136 | 174 |
| Total, other adverse events | Roll Over Placebo | 61 | 70 |
| Total, serious adverse events | De Novo | 3 | 86 |
| Total, serious adverse events | Roll Over Aripiprazole | 5 | 174 |
| Total, serious adverse events | Roll Over Placebo | 1 | 70 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00365859
GET https://conductscience.org/api/trials/v1/NCT00365859/registered?page=2