Trial · NCT00844753
Atomoxetine, Placebo and Parent Management Training in Autism
NCT00844753, Phase 4, Completed, University of Rochester; results first posted 2016-02-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atomoxetine, Placebo and Parent Management Training in Autism. Trials, record NCT00844753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00844753
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atomoxetine, Placebo and Parent Management Training in Autism
- NCT number
- NCT00844753
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 128 participants, actual
- Lead sponsor
- University of Rochester
- Conditions
- Autism, Pervasive Development Disorder, Asperger's Disorder, Attention Deficit Hyperactivity Disorder
- Interventions
- atomoxetine, Placebo, Parent Management Training
- First posted
- 2009-02-16
- Last updated
- 2016-02-04
- Results first posted
- 2016-02-04
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents | week 10 | Respondents were defined as having ≥30% decrease on the SNAP and CGI-I\<=2). The Swanson, Nolan, and Pelham (SNAP)-IV Parent and Teacher Rating Scales were used to measure ADHD and oppositional symptoms at home and school. The SNAP-IV ADHD section contains items for each of the 18 Diagnostic and Statistical Manual of Mental Disorders-IV symptoms of ADHD rated from 0 (not at all) to 3 (very much). The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill), with a rating of ≥4 required for inclusion. The Improvement score ranged from 1 (very much improved) through 4 (no change) to 7 (very much worse). The CGI was completed by a blinded rater based on parent/child interview and review of completed parent and school behavior problem questionnaires at each study visit. |
| Primary | Percentage of Participants Who Were Autism Spectrum Disorder Respondents | week 10 | Respondents were defined as having ≥30% decrease on the HSQ and CGI-I≤2). The 25-item HSQ was adapted by the Research Units on Pediatric Psychopharmacology Autism Network to evaluate behavioral noncompliance in children with autism spectrum disorder (ASD). The Home Situations Questionnaire - Pervasive Developmental Disorder (HSQ) is a 25-item parent rating scale assessing noncompliance. Parents are asked to indicate whether each item is a problem and, if so, its severity from 1 (mild) to 9 (severe). The School Situations Questionnaire (SSQ) is a 9-item teacher rating scale that assesses noncompliance. The SSQ is a companion instrument to the HSQ and uses the same rating scale. The Clinical Global Impressions Scale (CGI) includes subscales for severity of illness and global improvement. The Severity scale is scored from 1 (normal) to 7 (extremely ill), |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents | week 10 | percentage of participants | NUMBER | |
| PRIMARY | Percentage of Participants Who Were Autism Spectrum Disorder Respondents | week 10 | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents | Atomoxetine + Parent Management Training | 45.2 | percentage of participants | ||
| Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents | Atomoxetine Without Parent Management Training | 46.9 | percentage of participants | ||
| Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents | Placebo + Parent Management Training | 29.0 | percentage of participants | ||
| Percentage of Participants Who Were Attention Deficit Hyperactivity Disorder (ADHD) Respondents | Placebo Without Parent Management Training | 19.4 | percentage of participants | ||
| Percentage of Participants Who Were Autism Spectrum Disorder Respondents | Atomoxetine + Parent Management Training | 22.6 | percentage of participants | ||
| Percentage of Participants Who Were Autism Spectrum Disorder Respondents | Atomoxetine Without Parent Management Training | 43.8 | percentage of participants | ||
| Percentage of Participants Who Were Autism Spectrum Disorder Respondents | Placebo + Parent Management Training | 38.7 | percentage of participants | ||
| Percentage of Participants Who Were Autism Spectrum Disorder Respondents | Placebo Without Parent Management Training | 16.4 | percentage of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Atomoxetine (ATX) + Parent Management Training | 32 | |
| Overall Study | STARTED | Atomoxetine (ATX) Without Parent Management Training | 32 | |
| Overall Study | STARTED | Placebo + Parent Management Training | 32 | |
| Overall Study | STARTED | Placebo Without Parent Management Training | 32 | |
| Overall Study | COMPLETED | Atomoxetine (ATX) + Parent Management Training | 24 | |
| Overall Study | COMPLETED | Atomoxetine (ATX) Without Parent Management Training | 29 | |
| Overall Study | COMPLETED | Placebo + Parent Management Training | 25 | |
| Overall Study | COMPLETED | Placebo Without Parent Management Training | 21 | |
| Overall Study | NOT COMPLETED | Atomoxetine (ATX) + Parent Management Training | 8 | |
| Overall Study | NOT COMPLETED | Atomoxetine (ATX) Without Parent Management Training | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events18
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 | Irritability | Psychiatric disorders | Atomoxetine | 27 | 63 | |
| other | Irritability | Psychiatric disorders | Placebo | 29 | 62 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Atomoxetine | 30 | 63 | |
| other | Decreased Appetite | Metabolism and nutrition disorders | Placebo | 18 | 62 | |
| other | Agitation | Psychiatric disorders | Atomoxetine | 19 | 63 | |
| other | Agitation | Psychiatric disorders | Placebo | 20 | 62 | |
| other | Difficulty sleeping | General disorders | Atomoxetine | 19 | 63 | |
| other | Difficulty sleeping | General disorders | Placebo | 11 | 62 | |
| other | Vomiting | Gastrointestinal disorders | Atomoxetine | 14 | 63 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 10 | 62 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Atomoxetine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Atomoxetine | 59 | 63 |
| Total, other adverse events | Placebo | 61 | 62 |
| Total, serious adverse events | Atomoxetine | 0 | 63 |
| Total, serious adverse events | Placebo | 0 | 62 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01MH079082 | 1/3-Atomoxetine Placebo and Parent Training in Autism | HANDEN, BENJAMIN L | UNIVERSITY OF PITTSBURGH AT PITTSBURGH | NATIONAL INSTITUTE OF MENTAL HEALTH | 2008 to 2012 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Atomoxetine vs Placebo: serious adverse events |
Source 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/NCT00844753
GET https://conductscience.org/api/trials/v1/NCT00844753/registered