Attention Deficit Hyperactivity DisorderPhase 2kiddie-CATNCT00414921
Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)
A Phase 2 study testing clonidine and methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by University of Cincinnati at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of two medications--clonidine and methylphenidate--alone or in combination to treat attention deficit hyperactivity disorder in children ages 4 through 6. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- clonidine and methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2003to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with ADHD
- Child ages 4 through 6
- Child attending a structured preschool or daycare
Who cannot join
- Presence of a tic disorder of any kind or a known active heart disease for which it would be unsafe to use the study drugs
- Presence of pervasive developmental disorder, autism, mental retardation, or serious psychiatric illness
- Child not attending a structured preschool or daycare
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Cincinnati, Department of Psychiatry, 231 Albert Sabin Way, M: 0559
Cincinnati, Ohio, 45267-0559
Western Psychiatric Institute and Clinic, ADD Program, 3811 Ohara Street
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center, Department of Neurology, 919 Westfall Road, Building C
Rochester, New York, 14618
About this study
The purpose of this study is to evaluate the safety and efficacy of two medications--clonidine and methylphenidate--alone or in combination to treat attention deficit hyperactivity disorder in children ages 4 through 6.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD) is a disease characterized by one or more symptoms of hyperactivity, impulsivity, or inattention that interfere with school, home, work, or social settings. ADHD does not have clear physical signs that can be seen in an x-ray or a lab test. The disorder only can be identified by looking for certain behaviors, which vary from person to person.
This trial will compare the benefits and side effects of two medications--clonidine and methylphenidate (MPH)--used alone or in combination to treat ADHD in children. MPH is approved by the Food and Drug Administration (FDA) for the treatment of ADHD symptoms in children, and clonidine is FDA-approved for the treatment of hypertension in adults. Stimulant medications such as MPH are known to safely and effectively treat many ADHD symptoms. Such medicines, however, do not cure the condition or improve all ADHD symptoms, and the long-term effectiveness of these medications is not well-known.
In this study, participants will be randomly selected to receive one of four treatments: 1) clonidine; 2) MPH; 3) clonidine and MPH; or 4) a placebo (an inactive substance). Participation in the study is about 16 weeks, and includes a baseline screening and 5 evaluation visits to assess attention, hyperactivity, overall improvement and general functioning, medication side effects, blood pressure, pulse, and weight.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- clonidine, methylphenidate, placebo
- Keywords
- Attention deficit hyperactivity disorder, ADHD, clonidine, methylphenidate, MPH
- 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.
clonidineDrug
Clonidine is FDA-approved for the treatment of hypertension in adults
methylphenidateDrug
Also called MPH
Methylphenidate is known to safely and effectively treat many ADHD symptoms.
placeboOther
inactive substance
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | clonidine Receives: Drug: clonidine |
| 2 | Active comparator | methylphenidate Receives: Drug: methylphenidate |
| 3 | Active comparator | methylphenidate and clonidine Receives: Drug: clonidine; Drug: methylphenidate |
| 4 | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)
Measured: at 16 weeks
Secondary outcomes (1)
the ASQ-Parent (ASQ-P) and Child Global Assessment Scales (C-GAS). Adverse events were monitored using AE logs, the Pittsburgh Side Effects Rating Scale, vital signs and electrocardiograms.
Measured: at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2006 (estimated)
- Study startSep 2003
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Investigators
- Floyd Randy Sallee, MD/PhD, Principal investigator, University of CincinnatiOscar Bukstein, MD, Principal investigator, Western Psychiatric Institute and ClinicDonna Palumbo, PhD, Principal investigator, University of RochesterWilliam Pelham, PhD, Principal investigator, SUNY Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414921
- Sponsor's protocol ID
- R01NS39087_kiddie-CAT
- Other IDs
- R01NS039087
- Acronym
- kiddie-CAT
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2006
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preschool Supplement to Clonidine in ADHD (Kiddie-CAT)
- ClinicalTrials.gov ID
- NCT00414921
- Acronym / sponsor ID
- kiddie-CAT / R01NS39087_kiddie-CAT
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention deficit hyperactivity disorder, ADHD, clonidine, methylphenidate, MPH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Sep 2003
- Study completion
- Jun 2007 (actual)
- First posted
- 22 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of two medications--clonidine and methylphenidate--alone or in combination to treat attention deficit hyperactivity disorder in children ages 4 through 6.
Detailed description
Attention deficit hyperactivity disorder (ADHD) is a disease characterized by one or more symptoms of hyperactivity, impulsivity, or inattention that interfere with school, home, work, or social settings. ADHD does not have clear physical signs that can be seen in an x-ray or a lab test. The disorder only can be identified by looking for certain behaviors, which vary from person to person.
This trial will compare the benefits and side effects of two medications--clonidine and methylphenidate (MPH)--used alone or in combination to treat ADHD in children. MPH is approved by the Food and Drug Administration (FDA) for the treatment of ADHD symptoms in children, and clonidine is FDA-approved for the treatment of hypertension in adults. Stimulant medications such as MPH are known to safely and effectively treat many ADHD symptoms. Such medicines, however, do not cure the condition or improve all ADHD symptoms, and the long-term effectiveness of these medications is not well-known.
In this study, participants will be randomly selected to receive one of four treatments: 1) clonidine; 2) MPH; 3) clonidine and MPH; or 4) a placebo (an inactive substance). Participation in the study is about 16 weeks, and includes a baseline screening and 5 evaluation visits to assess attention, hyperactivity, overall improvement and general functioning, medication side effects, blood pressure, pulse, and weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: clonidineclonidine |
| 2 | Active comparator | Drug: methylphenidatemethylphenidate |
| 3 | Active comparator | Drug: clonidine, Drug: methylphenidatemethylphenidate and clonidine |
| 4 | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child with ADHD
- Child ages 4 through 6
- Child attending a structured preschool or daycare
Key exclusion criteria (3 listed)
- Presence of a tic disorder of any kind or a known active heart disease for which it would be unsafe to use the study drugs
- Presence of pervasive developmental disorder, autism, mental retardation, or serious psychiatric illness
- Child not attending a structured preschool or daycare
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 |
|---|---|---|
| clonidineClonidine is FDA-approved for the treatment of hypertension in adults | Drug | 1, 3 |
| methylphenidateAlso: MPHMethylphenidate is known to safely and effectively treat many ADHD symptoms. | Drug | 2, 3 |
| placeboinactive substance | Other | 4 |
Primary outcome
change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T)
Time frame: at 16 weeks
1 secondary outcome
the ASQ-Parent (ASQ-P) and Child Global Assessment Scales (C-GAS). Adverse events were monitored using AE logs, the Pittsburgh Side Effects Rating Scale, vital signs and electrocardiograms.
Time frame: at 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2009.
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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.
Floyd Randy Sallee, MD/PhD principal investigator
University of Cincinnati
Oscar Bukstein, MD principal investigator
Western Psychiatric Institute and Clinic
Donna Palumbo, PhD principal investigator
University of Rochester
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing clonidine and methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by University of Cincinnati at 3 sites 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 3 inclusion and 3 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 21 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in score on the Conners Abbreviated Symptom Questionnaire for Teachers (ASQ-T) (time frame: at 16 weeks). 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 21 May 2009.