Trial · NCT00870727
Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders
NCT00870727, Phase 3, Completed, Indiana University; results first posted 2018-11-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Aripiprazole in the Treatment of Pervasive Developmental Disorders. Trials, record NCT00870727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00870727
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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 Pervasive Developmental Disorders
- NCT number
- NCT00870727
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Pervasive Developmental Disorder
- Interventions
- Aripiprazole oral product, Placebo oral capsule
- First posted
- 2009-03-27
- Last updated
- 2019-01-02
- Results first posted
- 2018-11-28
- Limitations and caveats
The PI who conducted the trial left the institution, Indiana University, prior to data analysis. The institution negotiated/executed a data transfer agreement for the PI's primary mentor, Dr. Christopher McDougle, to analyze the data on her behalf.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) | Double-blind phase study exit - up to 8 weeks | Clinical Global Impressions (Guy, 1976) global improvement (CGI-I) is designed to take into account all factors to arrive at an assessment of response to treatment. The CGI-I scale ranges from 1 to 7, with lower scores indicating greater improvement (1=very much improved and 2=much improved). Participants with a CGI-I score of 1 or 2 were classified as improved. Four participants assigned to placebo completed an exit interview prior to week 8. One participant assigned to placebo and one participant assigned to aripiprazole withdrew from the study without completing an exit interview. |
| Primary | Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Irritability subscale is 0 to 45. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. Confidence intervals reflect a Bonferroni multiple testing correction accounting for the selection of two primary outcomes. |
| Secondary | Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. The 16-item Hyperactivity subscale covers overactivity (7 items), impulsiveness (2 items), inattention (3 items) and noncompliance (4 items). It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores is 0 to 48 on the Hyperactivity subscale. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. |
| Secondary | Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Inappropriate Speech subscale is 0 to 12. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. |
| Secondary | Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item Parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Social Withdrawal subscale is 0 to 48. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. |
| Secondary | Mean Post-baseline Aberrant Behavior Checklist Stereotypy Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | The Aberrant Behavior Checklist (ABC) is a symptom checklist for assessing problem behaviors in individuals ages 6 to 54 years-old with mental retardation. The full ABC is a 58-item parent rating with five factors: Irritability, Social Withdrawal, Stereotypy, Hyperactivity and Inappropriate Speech. It has been used as a primary outcome measure in several trials in children with developmental disabilities. The interpretation of the tool and its subscales is that a greater number of items indicates greater severity. The range of scores for the Stereotypy subscale is 0 to 21. Means were estimated using a repeated measures linear regression model with treatment group, baseline score, study week (in categories), and Tanner stage as covariates. A linear contrast estimated the average across study timepoints. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) | Double-blind phase study exit - up to 8 weeks | All randomized study participants who completed an exit interview | participants | NUMBER |
| PRIMARY | Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | All randomized study participants | units on a scale | MEAN |
| SECONDARY | Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | All randomized study participants | units on a scale | MEAN |
| SECONDARY | Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | All randomized study participants | units on a scale | MEAN |
| SECONDARY | Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | All randomized study participants | units on a scale | MEAN |
| SECONDARY | Mean Post-baseline Aberrant Behavior Checklist Stereotypy Subscale Score, Parent Report, Double-blind Phase | Weeks 1, 2, 3, 4, 6 and 8 | All randomized study participants | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) | Arm 1. Aripiprazole Oral Product | 11 | participants | ||
| Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) | Arm 2. Placebo Oral Capsule | 3 | participants | ||
| Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase | Arm 1. Aripiprazole Oral Product | 18.3 | 95% Confidence Interval 14.2 to 22.5 | units on a scale | |
| Mean Post-baseline Aberrant Behavior Checklist Irritability Subscale Score, Parent Report, Double-blind Phase | Arm 2. Placebo Oral Capsule | 26.4 | 95% Confidence Interval 22.1 to 30.8 | units on a scale | |
| Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase | Arm 1. Aripiprazole Oral Product | 23.8 | 95% Confidence Interval 19.7 to 28.0 | units on a scale | |
| Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Subscale Score, Parent Report, Double-blind Phase | Arm 2. Placebo Oral Capsule | 29.4 | 95% Confidence Interval 25.2 to 33.8 | units on a scale | |
| Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase | Arm 1. Aripiprazole Oral Product | 4.6 | 95% Confidence Interval 3.8 to 5.4 | units on a scale | |
| Mean Post-baseline Aberrant Behavior Checklist Inappropriate Speech Subscale Score, Parent Report, Double-blind Phase | Arm 2. Placebo Oral Capsule | 6.0 | 95% Confidence Interval 5.2 to 6.8 | units on a scale | |
| Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase | Arm 1. Aripiprazole Oral Product | 6.1 | 95% Confidence Interval 3.4 to 8.7 | units on a scale | |
| Mean Post-baseline Aberrant Behavior Checklist Social Withdrawal Subscale Score, Parent Report, Double-blind Phase | Arm 2. Placebo Oral Capsule | 9.6 | 95% Confidence Interval 6.8 to 12.4 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1. Aripiprazole Oral Product | 17 | |
| Overall Study | STARTED | Arm 2. Placebo Oral Capsule | 16 | |
| Overall Study | COMPLETED | Arm 1. Aripiprazole Oral Product | 16 | |
| Overall Study | COMPLETED | Arm 2. Placebo Oral Capsule | 11 | |
| Overall Study | NOT COMPLETED | Arm 1. Aripiprazole Oral Product | 1 | |
| Overall Study | NOT COMPLETED | Arm 2. Placebo Oral Capsule | 5 |
Source ClinicalTrials.gov
Adverse events86
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 | Constipation | Gastrointestinal disorders | Arm 1. Aripiprazole Oral Product | 1 | 17 | |
| other | Constipation | Gastrointestinal disorders | Arm 2. Placebo Oral Capsule | 0 | 16 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 1. Aripiprazole Oral Product | 1 | 17 | |
| other | Diarrhea | Gastrointestinal disorders | Arm 2. Placebo Oral Capsule | 0 | 16 | |
| other | Flatulence | Gastrointestinal disorders | Arm 1. Aripiprazole Oral Product | 1 | 17 | |
| other | Flatulence | Gastrointestinal disorders | Arm 2. Placebo Oral Capsule | 0 | 16 | |
| other | Nausea | Gastrointestinal disorders | Arm 1. Aripiprazole Oral Product | 1 | 17 | |
| other | Nausea | Gastrointestinal disorders | Arm 2. Placebo Oral Capsule | 0 | 16 | |
| other | Stomach or abdominal discomfort | Gastrointestinal disorders | Arm 1. Aripiprazole Oral Product | 4 | 17 | |
| other | Stomach or abdominal discomfort | Gastrointestinal disorders | Arm 2. Placebo Oral Capsule | 3 | 16 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1. Aripiprazole Oral Product | 0 | 17 |
| Total, all-cause mortality | Arm 2. Placebo Oral Capsule | 0 | 16 |
| Total, other adverse events | Arm 1. Aripiprazole Oral Product | 16 | 17 |
| Total, other adverse events | Arm 2. Placebo Oral Capsule | 13 | 16 |
| Total, serious adverse events | Arm 1. Aripiprazole Oral Product | 0 | 17 |
| Total, serious adverse events | Arm 2. Placebo Oral Capsule | 0 | 16 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm 1. Aripiprazole Oral Product vs Arm 2. Placebo Oral Capsule: Number of Participants Improved as Measured by the Clinical Global Impression-Global Improvement Scale (Improvement Defined as CGI-I=1 or CGI-I=2) | Trial comparisons |
| Arm 1. Aripiprazole Oral Product vs Arm 2. Placebo Oral Capsule: deaths from any cause | Trial comparisons |
| Arm 1. Aripiprazole Oral Product vs Arm 2. Placebo Oral Capsule: serious adverse events | Trial comparisons |
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/NCT00870727
GET https://conductscience.org/api/trials/v1/NCT00870727/events?page=2