Trial · NCT00550147
Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior.
NCT00550147, Phase 2, Completed, Indiana University; results first posted 2015-05-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior. Trials, record NCT00550147. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00550147
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior.
- NCT number
- NCT00550147
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Interventions
- Oros Methylphenidate, quetiapine
- First posted
- 2007-10-29
- Last updated
- 2015-05-13
- Results first posted
- 2015-05-13
- Limitations and caveats
There were no unanticipated limitations/caveats. All of the typical caveats of open-label studies apply: As a result, bias, placebo effects, demand characteristics, and other non-treatment related effects may have contributed to results.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | RAAPP: Rating of Aggression Against People and/or Property Scale | See Arm/Group - Repeated Measures | The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior). |
| Secondary | CGI-S: Clinical Global Improvement Scale | See Arm/Group - Repeated Measures | The CGI-S is a 1-7 investigator rating of overall severity of target behavioral symptoms, which will be completed at each visit as a secondary efficacy measure of global behavioral functioning. A score of 1 indicates "normal, not ill at all" and a score of 7 indicates "among the most extremely ill patients". |
| Secondary | Modified Overt Aggression Scale (MOAS) | See arm/group - repeated measures | The Modified Overt Aggression Scale (MOAS) is a clinician-rated scale of aggressive outbursts experienced in the past week. Weightings are assigned for severity and frequency of aggression. MOAS total severity score will be completed as a secondary efficacy measure of aggressive behavior. The range for the MOAS is 0-235. A score of 0 indicates "no aggression" and a score of 235 indicates "the most severe and frequent aggressive outbursts". |
| Secondary | Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale | See arm/group - repeated measures analysis | The Swanson, Nolan and Pelham (SNAP-IV) is a 90-item, parent-completed questionnaire consisting of symptoms of ADHD, aggression, depression, and mania. Parents rate each item from 0(not at all) to 3 (very much) based on their child's behavior during the past week. The scores from the Oppositional-Defiant Disorder section of this questionnaire will be used as secondary efficacy measures of parent-reported aggressive behavior. These scores range from 0-24. |
| Secondary | Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version) | See Arm/Group - repeated measures | The Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent:Inv) (Faries, Yalcin, Harder, \& Heiligenstein, 2001) is an interviewer-administered semi structured interview with the parent, focusing on the 18 DSM-IV symptoms. Ratings are made on a 0 (never or rarely) to 3 (very often) scale. The range of the ADHDRS-IV is 0-54. A zero (0) scores indicates no ADHD symptoms and 54 indicates most severe ADHD symptoms. The ADHDRS-IV-Parent:Inv provides an overall severity score, symptom count, and ADHD diagnosis for the child. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | RAAPP: Rating of Aggression Against People and/or Property Scale | See Arm/Group - Repeated Measures | Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF). | units on a scale | MEAN |
| SECONDARY | CGI-S: Clinical Global Improvement Scale | See Arm/Group - Repeated Measures | Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF). | units on a scale | MEAN |
| SECONDARY | Modified Overt Aggression Scale (MOAS) | See arm/group - repeated measures | Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF). | units on a scale | MEAN |
| SECONDARY | Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale | See arm/group - repeated measures analysis | Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF). | units on a scale | MEAN |
| SECONDARY | Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version) | See Arm/Group - repeated measures | Participants were those who qualified for the augmentation portion of the study (inadequate response to Oros MPH alone). Analysis was per protocol (intent-to-treat, LOCF). | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| RAAPP: Rating of Aggression Against People and/or Property Scale | Baseline | 4.3 | Standard Deviation 0.4 | units on a scale | |
| RAAPP: Rating of Aggression Against People and/or Property Scale | Visit 5 - MPH Monotherapy - Week 4 | 3.2 | Standard Deviation 0.6 | units on a scale | |
| RAAPP: Rating of Aggression Against People and/or Property Scale | Visit 10 - MPH+Quetiapine - Week 13 | 2.0 | Standard Deviation 0.8 | units on a scale | |
| CGI-S: Clinical Global Improvement Scale | Baseline | 5.3 | Standard Deviation 0.6 | units on a scale | |
| CGI-S: Clinical Global Improvement Scale | Visit 5 - MPH Monotherapy - Week 4 | 4.1 | Standard Deviation 0.8 | units on a scale | |
| CGI-S: Clinical Global Improvement Scale | Visit 10 - MPH + Quetiapine - Week 13 | 2.8 | Standard Deviation 0.9 | units on a scale | |
| Modified Overt Aggression Scale (MOAS) | Baseline | 229.0 | Standard Deviation 194.3 | units on a scale | |
| Modified Overt Aggression Scale (MOAS) | Visit 5 - MPH Monotherapy - Week 4 | 73.7 | Standard Deviation 57.9 | units on a scale | |
| Modified Overt Aggression Scale (MOAS) | Visit 10 - MPH + Quetiapine - Week 13 | 26.3 | Standard Deviation 33.0 | units on a scale | |
| Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale | Baseline | 19.0 | Standard Deviation 4.1 | units on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| OROS Methylphenidate Monotherapy | STARTED | OROS Methylphenidate and Quetiapine | 30 | |
| OROS Methylphenidate Monotherapy | COMPLETED | OROS Methylphenidate and Quetiapine | 24 | |
| OROS Methylphenidate Monotherapy | NOT COMPLETED | OROS Methylphenidate and Quetiapine | 6 | |
| Quetiapine Addition Treatment Period | STARTED | OROS Methylphenidate and Quetiapine | 24 | |
| Quetiapine Addition Treatment Period | COMPLETED | OROS Methylphenidate and Quetiapine | 18 | |
| Quetiapine Addition Treatment Period | NOT COMPLETED | OROS Methylphenidate and Quetiapine | 6 |
Source ClinicalTrials.gov
Adverse events11
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 | repiratory illness | Respiratory, thoracic and mediastinal disorders | OROS Methylphenidate and Quetiapine | 9 | 24 | 9 |
| other | headache | General disorders | OROS Methylphenidate and Quetiapine | 4 | 24 | 4 |
| other | fatigue/sedation | General disorders | OROS Methylphenidate and Quetiapine | 12 | 24 | 12 |
| other | reduced appetite | Metabolism and nutrition disorders | OROS Methylphenidate and Quetiapine | 4 | 24 | 4 |
| other | difficulty sleeping | General disorders | OROS Methylphenidate and Quetiapine | 7 | 24 | 7 |
| other | stomachache/nausea | Gastrointestinal disorders | OROS Methylphenidate and Quetiapine | 7 | 24 | 7 |
| other | vomiting | Gastrointestinal disorders | OROS Methylphenidate and Quetiapine | 4 | 24 | 4 |
| other | flu-like syndrome | General disorders | OROS Methylphenidate and Quetiapine | 5 | 24 | 5 |
| other | lability/irritability | General disorders | OROS Methylphenidate and Quetiapine | 4 | 24 | 4 |
| other | bruises/cuts/bumps | Skin and subcutaneous tissue disorders | OROS Methylphenidate and Quetiapine | 3 | 24 | 3 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | OROS Methylphenidate and Quetiapine | ||
| Total, other adverse events | OROS Methylphenidate and Quetiapine | 23 | 24 |
| Total, serious adverse events | OROS Methylphenidate and Quetiapine | 0 | 24 |
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 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/NCT00550147
GET https://conductscience.org/api/trials/v1/NCT00550147/registered