Attention Deficit Disorder With HyperactivityPhase 2NCT00550147
Quetiapine and Concerta in the Treatment for ADHD and Aggressive Behavior.
A Phase 2 study testing Oros Methylphenidate and quetiapine in people with Attention Deficit Disorder With Hyperactivity, run by Indiana University at 1 site in United States.
Trial summary
The primary purpose of this thirteen-week, open-label study is to test the hypothesis that quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in children and adolescents who have shown inadequate response to OROS methylphenidate alone. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Oros Methylphenidate and quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Nov 2005
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must be at least 12 yrs.old but less than 18 when informed consent is obtained.
- Subjects must meet DSM-IV criteria for ADHD/Combined Type and one of the Disruptive Behavior Disorders as diagnosed by clinical interview and confirmed by the Kiddie-SADS-PL (K-SADS-PL) semistructured diagnostic interview.
- Subjects must have one DSM-IV aggressive feature of Conduct Disorder (CD) as rated on the K-SADS-PL including:
- initiation of physical fights (CD symptom A2)
- use of a weapon to bring harm to others (CD symptom A3)
- physical cruelty to people (CD symptom A4) or animals (CD symptom A5)
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- confrontation stealing (CD symptom A6)
- destruction of property (CD symptom A8 or A9).
- Subjects must have severe aggressive and ADHD symptoms as indicated by a global CGI score of 4 or greater and a RAAPP score of 4 or 5 at Visit 1.
- Subjects must have had at least four outbursts per month involving destruction of property, verbal aggression, or physical aggression toward others or self during the past two months at Visit 1.
- Subjects with previous trials of psychostimulants must have had a response insufficient to markedly change overall quality of life as defined by a CGI score of 3 or greater based on interview with the parent.
- Subjects must not have taken any medication for the treatment of ADHD or DBD for either 5 half-lives of the medication or 28 days (whichever is less) at Visit 1. If subjects are currently taking medications for the treatment of ADHD or DBD, the assent and consent must be reviewed and signed by the subject and parent/legal guardians (Visit 0) before the physician investigator will provide a tapering schedule for current medications.
- Laboratory results obtained at Visit 1 must be reviewed by a physician by Visit 2 and show no significant abnormalities.
- Baseline electrocardiogram (ECG) results obtained at Visit 1 must be assessed by a physician by Visit 2 and show no significant abnormalities.
Who cannot join
- Subjects with likely mental retardation as defined as a K-BIT Matrices IQ score of less than 70 at Visit 1.
- Subjects who meet criteria for bipolar disorder as diagnosed by clinical interview and confirmed by the K-SADS-PL at Visit 1.
- Subjects with a biological parent or sibling who meets criteria for bipolar disorder.
- Subjects who have any history of psychosis.
- Subjects who weigh less than 30kg or more than 80kg at study entry.
- Female subjects who are pregnant or who are breast-feeding as assessed at Visit 1.
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- Postmenarcheal sexually-active females who are not using a clinically acceptable method of birth control.
- Subjects with a history of any seizure disorder other than febrile seizures.
- Subjects with a history of alcohol or drug abuse within the past three months or who are currently using alcohol, drugs of abuse, or any prescribed or over-the-counter medications in a manner considered abusive by the investigators.
- Subjects currently taking any psychotropic medications or who are likely to need psychotropic medications during the study as assessed by the physician at Visit 1.
- Subjects considered to be at serious suicidal risk.
- Subjects taking any medications that are not reviewed and approved by a physician investigator. Specific requirements include:
- Psychotropic medications other than quetiapine and Concerta may not be used during the trial.
- Patients may receive lorazepam or chlorpromazine if needed for severe aggression. These drugs should not be given beyond 24 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
Riley Childrens Hospital
Indianapolis, Indiana, 46202
About this study
Official title: An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior
The primary purpose of this thirteen-week, open-label study is to test the hypothesis that quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in children and adolescents who have shown inadequate response to OROS methylphenidate alone.
Read the detailed description
Informed consent will be obtained from the subject and parent or legal guardian before any study procedures begin. Study procedures will include the verification of inclusion and exclusion criteria, and completion of assessments and safety measures (physical examination, vital signs, adverse events and concomitant medication review, AIMS, laboratory tests, ECG, pregnancy test) as indicated in the Schedule of Events. All laboratory and electrocardiogram results must be reviewed by a physician before the subject returns for Visit 2.
Study Period II (Visits 2-5)
All subjects meeting entry criteria will initially receive Oros methylphenidate beginning at Visit 2. The Oros methylphenidate will be titrated over 3 visits according to the following schedule:
- Visit 2 dose of 18 mg QAM
- Visit 3 dose of 36mg QAM
- Visit 4 dose of 54mg QAM.
- At Visit 5, any subjects unable to tolerate continuation of the Oros methylphenidate dose of 54mg QAM or subjects that meet improvement criteria as defined above will be discontinued from the study. Subjects able to tolerate the daily dose of 54mg Oros methylphenidate and who do not meet improvement criteria at Visit 5 will begin receiving quetiapine in addition to continuing Oros methylphenidate at 54mg QAM for the balance of the study. The initial dose of quetiapine dispensed at Visit 5 will be 25mg QAM for one day with an increase to 25mg BID until Visit 6.
At each visit safety and efficacy information will be completed according to the Schedule of Events.
Study Period III (Visits 6-10) Quetiapine will be titrated at Visits 6 - 9 according to the parameters in the quetiapine dosing schedule and the completion of safety and efficacy measures listed in the Schedule of Events. A telephone follow-up with the parent or legal guardian will be made 7-9 days after Visit 8 for physician review of subject adverse events and safety.
At visit 10 subjects will be given clinical recommendations for follow-up care from a physician investigator after completion of all study procedures (labs/EKG, vital signs, physical exam, AIMS, ADHD-RS-IV, CGI-I, CGI-S, RAAPP, MOAS, SNAP, CCPT)
- Being tested
- Oros Methylphenidate, quetiapine
- Keywords
- ADHD-Combined TypeDisruptive behavior Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oros MethylphenidateDrug
Also called Concerta
Oros methylphenidate will be titrated over 3 visits according to the following schedule:
- Visit 2 dose of 18 mg QAM
- Visit 3 dose of 36mg QAM
- Visit 4 dose of 54mg QAM.
quetiapineDrug
Also called Seroquel
Quetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (See Table 1).
Table 1: Quetiapine Dosing Schedule (subject's required weight = 30-80 kg)
- Visit 5 dose of 25mg BID
- Visit 6 dose of 50mg BID
- Visit 7 dose of 100mg BID
- Visit 8 dose of 200mg BID
- Visit 9 dose of 300mg BID
Efficacy: For any visit following Visit 5, dosage will remain stable if clinically significant improvement criteria are met.If subjects subsequently fail to meet clinically significant improvement criteria, dose increases will resume at the next level of the dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oros Methylphenidate and Quetiapine Receives: Drug: Oros Methylphenidate; Drug: quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
RAAPP: Rating of Aggression Against People and/or Property Scale
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).
Measured: See Arm/Group - Repeated Measures
Secondary outcomes (4)
CGI-S: Clinical Global Improvement Scale
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".
Measured: See Arm/Group - Repeated Measures
Modified Overt Aggression Scale (MOAS)
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".
Measured: See arm/group - repeated measures
Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale
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.
Measured: See arm/group - repeated measures analysis
Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)
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.
Measured: See Arm/Group - repeated measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startFeb 2004
- Primary completionNov 2005
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Dunn, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550147
- Sponsor's protocol ID
- 0307-31 (IRB#)
- Status last verified
- May 2015
- First submitted
- 25 Oct 2007
- Last updated
- 13 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior
- ClinicalTrials.gov ID
- NCT00550147
- Acronym / sponsor ID
- 0307-31 (IRB#)
- Keywords
- ADHD-Combined TypeDisruptive behavior Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Nov 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 29 Oct 2007 (estimated)
- Results
- Posted 13 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this thirteen-week, open-label study is to test the hypothesis that quetiapine in combination with Oros methylphenidate will reduce aggressive symptoms in children and adolescents who have shown inadequate response to OROS methylphenidate alone.
Detailed description
Informed consent will be obtained from the subject and parent or legal guardian before any study procedures begin. Study procedures will include the verification of inclusion and exclusion criteria, and completion of assessments and safety measures (physical examination, vital signs, adverse events and concomitant medication review, AIMS, laboratory tests, ECG, pregnancy test) as indicated in the Schedule of Events. All laboratory and electrocardiogram results must be reviewed by a physician before the subject returns for Visit 2.
Study Period II (Visits 2-5)
All subjects meeting entry criteria will initially receive Oros methylphenidate beginning at Visit 2. The Oros methylphenidate will be titrated over 3 visits according to the following schedule:
- Visit 2 dose of 18 mg QAM
- Visit 3 dose of 36mg QAM
- Visit 4 dose of 54mg QAM.
- At Visit 5, any subjects unable to tolerate continuation of the Oros methylphenidate dose of 54mg QAM or subjects that meet improvement criteria as defined above will be discontinued from the study. Subjects able to tolerate the daily dose of 54mg Oros methylphenidate and who do not meet improvement criteria at Visit 5 will begin receiving quetiapine in addition to continuing Oros methylphenidate at 54mg QAM for the balance of the study. The initial dose of quetiapine dispensed at Visit 5 will be 25mg QAM for one day with an increase to 25mg BID until Visit 6.
At each visit safety and efficacy information will be completed according to the Schedule of Events.
Study Period III (Visits 6-10) Quetiapine will be titrated at Visits 6 - 9 according to the parameters in the quetiapine dosing schedule and the completion of safety and efficacy measures listed in the Schedule of Events. A telephone follow-up with the parent or legal guardian will be made 7-9 days after Visit 8 for physician review of subject adverse events and safety.
At visit 10 subjects will be given clinical recommendations for follow-up care from a physician investigator after completion of all study procedures (labs/EKG, vital signs, physical exam, AIMS, ADHD-RS-IV, CGI-I, CGI-S, RAAPP, MOAS, SNAP, CCPT)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oros Methylphenidate, Drug: quetiapineOros Methylphenidate and Quetiapine |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Subjects must be at least 12 yrs.old but less than 18 when informed consent is obtained.
- Subjects must meet DSM-IV criteria for ADHD/Combined Type and one of the Disruptive Behavior Disorders as diagnosed by clinical interview and confirmed by the Kiddie-SADS-PL (K-SADS-PL) semistructured diagnostic interview.
- Subjects must have one DSM-IV aggressive feature of Conduct Disorder (CD) as rated on the K-SADS-PL including:
- Subjects must have severe aggressive and ADHD symptoms as indicated by a global CGI score of 4 or greater and a RAAPP score of 4 or 5 at Visit 1.
- Subjects must have had at least four outbursts per month involving destruction of property, verbal aggression, or physical aggression toward others or self during the past two months at Visit 1.
Key exclusion criteria (14 listed)
- Subjects with likely mental retardation as defined as a K-BIT Matrices IQ score of less than 70 at Visit 1.
- Subjects who meet criteria for bipolar disorder as diagnosed by clinical interview and confirmed by the K-SADS-PL at Visit 1.
- Subjects with a biological parent or sibling who meets criteria for bipolar disorder.
- Subjects who have any history of psychosis.
- Subjects who weigh less than 30kg or more than 80kg at study entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oros MethylphenidateAlso: ConcertaOros methylphenidate will be titrated over 3 visits according to the following schedule: * Visit 2 dose of 18 mg QAM * Visit 3 dose of 36mg QAM * Visit 4 dose of 54mg QAM. | Drug | 1 |
| quetiapineAlso: SeroquelQuetiapine will be titrated according to the following schedule as determined by efficacy and safety assessments (See Table 1). Table 1: Quetiapine Dosing Schedule (subject's required weight = 30-80 kg) * Visit 5 dose of 25mg BID * Visit 6 dose of 50mg BID * Visit 7 dose of 100mg BID * Visit 8 dose of 200mg BID * Visit 9 dose of 300mg BID Efficacy: For any visit following Visit 5, dosage will remain stable if clinically significant improvement criteria are met.If subjects subsequently fail to meet clinically significant improvement criteria, dose increases will resume at the next level of the dosing schedule. | Drug | 1 |
Primary outcome
RAAPP: Rating of Aggression Against People and/or Property Scale
Time frame: 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).
4 secondary outcomes
CGI-S: Clinical Global Improvement Scale
Time frame: See Arm/Group - Repeated Measures
Modified Overt Aggression Scale (MOAS)
Time frame: See arm/group - repeated measures
Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale
Time frame: See arm/group - repeated measures analysis
Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)
Time frame: See Arm/Group - repeated measures
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Dunn, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oros Methylphenidate and quetiapine in people with Attention Deficit Disorder With Hyperactivity, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RAAPP: Rating of Aggression Against People and/or Property Scale (time frame: See Arm/Group - Repeated Measures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.