Attention Deficit Disorder With HyperactivityPhase 3NCT00031395
Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) in Children
A Phase 3 study testing clonidine and methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by University of Cincinnati at 4 sites in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of clonidine alone or in combination with methylphenidate for children 7-12 years of age with attention-deficit, hyperactivity disorder. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- clonidine and methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 1999to Jun 2007
- Phase
- Phase 3
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 7 through 12 in school.
- All subjects must meet DSM IV criteria for the diagnosis of ADHD of any subtype [21].
- Each subject must also satisfy the following criteria regarding the severity of ADHD symptoms: 1. ADHD must be viewed as clinically significant and worthy of treatment by medications as judged by the parent and the site investigator. Operationally, medication treatment will be considered indicated for any subject who has ADHD symptoms that significantly interfere with academic or social functioning and that have not improved (or are not expected to improve) sufficiently with non-pharmacological interventions (e.g., modifying the classroom environment, tutoring). 2. The site investigator's rating of global functioning on the C-GAS must yield a score of 70 or below. Scores below 70 on the C-GAS are designated as indicating abnormal function [22]. The score of 70 corresponds to the anchor point description: "Some difficulty in a single area, but generally functioning pretty well."
- Screen of Intelligence using the vocabulary and block design subtests of the Wechsler Intelligence Scale for Children-Third Edition indicates an estimated I.Q > 70.
- Informed consent/assent signed. We will not enroll any child who does not want to participate.
- The designated school for each subject agrees to participate in the study by completing all required questionnaires and following all specified procedures.
- The child must be able to swallow the tablets and capsules used in this study.
Who cannot join
- Subjects with tic disorder of any type or tic symptoms, a primary diagnosis of major depression, pervasive developmental disorder, autism, any psychotic disorder, and mental retardation (based on current DSM criteria) will be excluded. We will not exclude subjects with obsessive-compulsive disorder, oppositional-defiant disorder or conduct disorder.
- The presence of a known medical condition that would preclude the use of MPH or clonidine.
- Known pregnancy. A urinary pregnancy test will be performed for all menstruating female subjects. Female subjects of child bearing potential will be advised not to become pregnant. In this circumstance, study medication will be tapered and discontinued and the subject will be terminated from the study. A urinary pregnancy test will be repeated at the end of the study. Subjects who request information regarding possible birth control mechanisms will be referred to their primary care physicians.
- Known presence of impaired renal function. A routine urinalysis will be performed for each subject to exclude signs of renal failure.
- Known active cardiovascular disease/anomaly, which would be a contraindication for the use of MPH or clonidine.
- Subjects may not receive any other medication for the treatment of ADHD. Treatment with MPH or other stimulants must be discontinued for at least 2 weeks prior to enrollment and treatment with other medications to treat ADHD (e.g., antidepressants, clonidine) must be discontinued for at least 6 weeks prior to enrollment.
- Subjects may not receive any other psychotropic medication (e.g., serotonin reuptake inhibitors), anxiolytics (e.g., clonazepam) or hypnotics. Any such medication must be discontinued at least 6 weeks prior to enrollment.
- Previous use of MPH or clonidine will be permitted.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
SUNY Buffalo, Center For Children & Families
Buffalo, New York, 14214
Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania
University of Rochester, Department of Neurology
Rochester, New York, 14642
About this study
Official title: Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT)
The purpose of this study is to determine the safety and efficacy of clonidine alone or in combination with methylphenidate for children 7-12 years of age with attention-deficit, hyperactivity disorder.
Read the detailed description
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 FDA-approved 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 be safe and effective for the treatment of many ADHD symptoms. Such medicines, however, do not cure the condition or improve all of the symptoms of ADHD, and the long-term effectiveness of these medications is not well-known. In this study the participants will be randomly selected to receive one of four treatments: 1.) clonidine; 2.) MPH; 3.) clonidine and MPH; or 4.) a placebo (which is not an active medication, but a substance that is thought to have no biological effect). The time participation in the study is 16 weeks.
- 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
MPH is FDA-approved for the treatment of ADHD symptoms in children.
placeboOther
an inactive substance
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: clonidine |
| 2 | Active comparator | Not described Receives: Drug: methylphenidate |
| 3 | Active comparator | Not described 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.
Efficacy outcome was 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 posted5 Mar 2002 (estimated)
- Study startSep 1999
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Investigators
- Floyd R. Sallee, M.D., Ph.D., Principal investigator, Children's Hospital & Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031395
- Sponsor's protocol ID
- R01NS039087
- Status last verified
- May 2009
- First submitted
- 4 Mar 2002
- Last updated
- 21 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cannon M, Pelham WH, Sallee FR, Palumbo DR, Bukstein O, Daviss WB. Effects of clonidine and methylphenidate on family quality of life in attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):511-7. doi: 10.1089/cap.2009.0008.
PubMed 19877975
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
- Clonidine in Attention Deficit Hyperactivity Disorder (ADHD) Treatment (CAT)
- ClinicalTrials.gov ID
- NCT00031395
- Acronym / sponsor ID
- R01NS039087
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, clonidine, methylphenidate, MPH
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Sep 1999
- Study completion
- Jun 2007 (actual)
- First posted
- 5 Mar 2002 (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 determine the safety and efficacy of clonidine alone or in combination with methylphenidate for children 7-12 years of age with attention-deficit, hyperactivity disorder.
Detailed description
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 FDA-approved 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 be safe and effective for the treatment of many ADHD symptoms. Such medicines, however, do not cure the condition or improve all of the symptoms of ADHD, and the long-term effectiveness of these medications is not well-known. In this study the participants will be randomly selected to receive one of four treatments: 1.) clonidine; 2.) MPH; 3.) clonidine and MPH; or 4.) a placebo (which is not an active medication, but a substance that is thought to have no biological effect). The time participation in the study is 16 weeks.
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: clonidine |
| 2 | Active comparator | Drug: methylphenidate |
| 3 | Active comparator | Drug: clonidine, Drug: methylphenidate |
| 4 | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 7 through 12 in school.
- All subjects must meet DSM IV criteria for the diagnosis of ADHD of any subtype [21].
- Each subject must also satisfy the following criteria regarding the severity of ADHD symptoms: 1. ADHD must be viewed as clinically significant and worthy of treatment by medications as judged by the parent and the site investigator. Operationally, medication treatment will be considered indicated for any subject who has ADHD symptoms that significantly interfere with academic or social functioning and that have not improved (or are not expected to improve) sufficiently with non-pharmacological interventions (e.g., modifying the classroom environment, tutoring). 2. The site investigator's rating of global functioning on the C-GAS must yield a score of 70 or below. Scores below 70 on the C-GAS are designated as indicating abnormal function [22]. The score of 70 corresponds to the anchor point description: "Some difficulty in a single area, but generally functioning pretty well."
- Screen of Intelligence using the vocabulary and block design subtests of the Wechsler Intelligence Scale for Children-Third Edition indicates an estimated I.Q > 70.
- Informed consent/assent signed. We will not enroll any child who does not want to participate.
Key exclusion criteria (8 listed)
- Subjects with tic disorder of any type or tic symptoms, a primary diagnosis of major depression, pervasive developmental disorder, autism, any psychotic disorder, and mental retardation (based on current DSM criteria) will be excluded. We will not exclude subjects with obsessive-compulsive disorder, oppositional-defiant disorder or conduct disorder.
- The presence of a known medical condition that would preclude the use of MPH or clonidine.
- Known pregnancy. A urinary pregnancy test will be performed for all menstruating female subjects. Female subjects of child bearing potential will be advised not to become pregnant. In this circumstance, study medication will be tapered and discontinued and the subject will be terminated from the study. A urinary pregnancy test will be repeated at the end of the study. Subjects who request information regarding possible birth control mechanisms will be referred to their primary care physicians.
- Known presence of impaired renal function. A routine urinalysis will be performed for each subject to exclude signs of renal failure.
- Known active cardiovascular disease/anomaly, which would be a contraindication for the use of MPH or clonidine.
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: MPHMPH is FDA-approved for the treatment of ADHD symptoms in children. | Drug | 2, 3 |
| placeboan inactive substance | Other | 4 |
Primary outcome
Efficacy outcome was 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.
- Derived from this study: PubMed 19877975Cannon M, Pelham WH, Sallee FR, Palumbo DR, Bukstein O, Daviss WB. Effects of clonidine and methylphenidate on family quality of life in attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2009 Oct;19(5):511-7. doi: 10.1089/cap.2009.0008.
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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 R. Sallee, M.D., Ph.D. principal investigator
Children's Hospital & Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing clonidine and methylphenidate in people with Attention Deficit Disorder With Hyperactivity, run by University of Cincinnati at 4 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 7 inclusion and 8 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 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Efficacy outcome was 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?
On the ClinicalTrials.gov record for NCT00031395, which also lists 1 linked publication.
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.