ADHDNCT00824317
Stimulant Drug Treatment of Attention-Deficit Hyperactivity Disorder (AD/HD), Inattentive Type
A study testing methylphenidate in people with ADHD, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to compare the response to methylphenidate treatment of children with two different subtypes of ADHD. Read more about this study
- Who is it for?
- Ages 7 to 13 years
- Conditions the study is for
- ADHD
- What is being tested?
- methylphenidate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2001to Feb 2005
- Phase
- Interventional
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A diagnosis on the structured DISC interview conducted with the parent, of ADHD, Predominantly Inattentive Type.
- Ratings by parent and by teacher corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV Inattention" on the current Conners Parent (or Teacher) Rating Scale - Long Form. The items on this scale are the inattention symptom criteria from the DSM-IV, each of which the informant is asked to rate in severity on a 4-point scale ranging in severity from 0 ("not at all") to 3 ("very much"). A score above the 93th percentile indicates that the child's score equals or exceeds that for 93% of other children of the same age (within 2 years) and gender.
- A diagnosis of ADHD, Combined type on the structured DISC interview with the parent.
- Ratings by parent and teacher each corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV attention" on the current Conners Parent (Teacher) Rating Scales - Long Form.
- Ratings by parent and teacher each corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV Hyperactive-Impulsive" symptoms on the current Conners Parent (Teacher) Rating Scales - Long Form.
- Both Groups:
- Inclusion Criterion: The child's school must agree to administer medication at mid-day and to allow the teacher to complete the requisite behavior ratings.
Who cannot join
- Scores more than 1 SD (84th percentile) above the mean on the DSM-IV-Hyperactive-Impulsive scale on the Conners Parent or Teacher Rating Scales-Long Form.
- Combined Subtype:
- WISC-III full-scale IQ less than 80.
- Major acute or chronic medical condition, including sensory loss, and neurological disorder, or any medical condition that would preclude the use of stimulant medication.
- Comorbidity: The study rationale for inclusion/exclusion of comorbid psychological/psychiatric conditions is as follows: children for whom the study treatment is contraindicated, or for whom treatment not provided in the study is required immediately, will not be entered in the trial. Thus, as an example, comorbid depression or anxiety disorder is permitted provided immediate treatment of the depressive or anxiety disorder is not required. Tic disorders of mild to moderate severity, and stable, would be eligible for inclusion, as this would not constitute a contraindication to receiving stimulants. However, children with pronounced or unstable tics would not be eligible for the trial.
- Children with any of the following conditions will be excluded from the study: psychosis, any pervasive developmental disorder, and bipolar disorder. Thus children will be permitted in the study if they have a comorbid learning disability, oppositional defiant disorder, or conduct disorder. The Wechsler Individual Achievement Tests will be administered in order that we can characterize our sample with respect to the presence of comorbid learning disabilities.
- Concomitant medications: Systemically absorbed medication will be exclusionary, while non-systemically absorbed medications will generally be permitted. Children who have taken any experimental medication in the past month will be excluded. Any prior psychotropic medication must have a suitable washout period of at least 4 half-lives before assessment can begin (generally a minimum of 2 weeks; up to 4 weeks for fluoxetine). Children taking methylphenidate at the time of inquiry may be withdrawn from medication only if treatment response is less than optimal and a re-evaluation is deemed clinically necessary. Children taking other psychotropic medication may be discontinued, provided their prescribing physician is in agreement with this plan, and provided there is clinical indication for doing so (i.e., either inadequate response, adverse effects or problematic time-action properties).
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai School of Medicine
New York, New York, 10029
About this study
Official title: Stimulant Drug Treatment of AD/HD, Inattentive Type
The purpose of this study is to compare the response to methylphenidate treatment of children with two different subtypes of ADHD.
Read the detailed description
The Inattentive subtype (IN) of Attention-Deficit/Hyperactivity Disorder was newly defined in DSM-IV (1994). Recent epidemiological studies suggest that IN is at least as common and as impairing academically and socially as the more commonly recognized Combined type (CB). However, little is known about the etiology, course and outcome, or treatment of the IN type. Notably, although stimulant drugs are commonly used clinically to treat the disorder, there have been no systematic studies of its efficacy in the IN subtype. Differences between the IN and CB subtypes in behavioral phenotype, as well as in gender ratio, age of onset, and comorbidity suggest there may be critical differences in neurobiology, which may have relevance for response to drug treatments. The lack of data concerning stimulant drug efficacy in the IN type thus constitutes an important issue from the perspective of public health and quality of care. The proposed research is responsive to the current RFA in that it will study the efficacy of an established treatment (stimulants) in a new patient population (the IN subtype). A second specific aim is to test a hypothesis, emerging from a review of the literature, of divergence between dose-response curves for effects on activity and attention. We predict that the dose that optimizes performance on ratings of hyperactivity-impulsivity will be lower than that which optimizes performance on ratings of academic function and on the neuropsychological tests. We will similarly examine whether differences in dose-response curves for specific functions extend to differences between subtypes in optimal dose. The final aim of the current study is to compare the IN and CB subtypes with respect to selected measures of neurocognitive function on placebo and in response to drug treatment. We predict that the IN subtype will perform more poorly on measures of spatial orienting and stimulus encoding, whereas the CB subtype will show greater deficits on measures of cognitive inhibitory control, and that both types of cognitive deficit will respond to drug treatment.
- Conditions
- ADHD
- Being tested
- methylphenidate, Placebo
- 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.
methylphenidateDrug
(15 mg daily), medium (25 mg daily) and high (40 mg daily)
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Drug: Placebo |
| 2 | Experimental | methylphenidate Receives: Drug: methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
(BLIND) CLINICIAN RATING ON ADHD-RS (SYMPTOM CHECKLIST) AND CGI (CLINICAL GLOBAL IMPRESSIONS)
Measured: Weekly
Secondary outcomes (1)
WEEKLY RATINGS BY PARENTS AND TEACHERS ON WELL-NORMED MEASURES OF ADHD SYMPTOMS AND FUNCTIONAL IMPAIRMENT PREVIOUSLY SHOWN TO BE DRUG-SENSITIVE (CONNERS AND SKAMP SCALES).
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startOct 2001
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 N/A
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Mary Solanto, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824317
- Sponsor's protocol ID
- 00-0394
- Other IDs
- R21MH062945
- Status last verified
- Jan 2009
- First submitted
- 15 Jan 2009
- Last updated
- 16 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulant Drug Treatment of AD/HD, Inattentive Type
- ClinicalTrials.gov ID
- NCT00824317
- Acronym / sponsor ID
- 00-0394
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2001
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 16 Jan 2009 (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 compare the response to methylphenidate treatment of children with two different subtypes of ADHD.
Detailed description
The Inattentive subtype (IN) of Attention-Deficit/Hyperactivity Disorder was newly defined in DSM-IV (1994). Recent epidemiological studies suggest that IN is at least as common and as impairing academically and socially as the more commonly recognized Combined type (CB). However, little is known about the etiology, course and outcome, or treatment of the IN type. Notably, although stimulant drugs are commonly used clinically to treat the disorder, there have been no systematic studies of its efficacy in the IN subtype. Differences between the IN and CB subtypes in behavioral phenotype, as well as in gender ratio, age of onset, and comorbidity suggest there may be critical differences in neurobiology, which may have relevance for response to drug treatments. The lack of data concerning stimulant drug efficacy in the IN type thus constitutes an important issue from the perspective of public health and quality of care. The proposed research is responsive to the current RFA in that it will study the efficacy of an established treatment (stimulants) in a new patient population (the IN subtype). A second specific aim is to test a hypothesis, emerging from a review of the literature, of divergence between dose-response curves for effects on activity and attention. We predict that the dose that optimizes performance on ratings of hyperactivity-impulsivity will be lower than that which optimizes performance on ratings of academic function and on the neuropsychological tests. We will similarly examine whether differences in dose-response curves for specific functions extend to differences between subtypes in optimal dose. The final aim of the current study is to compare the IN and CB subtypes with respect to selected measures of neurocognitive function on placebo and in response to drug treatment. We predict that the IN subtype will perform more poorly on measures of spatial orienting and stimulus encoding, whereas the CB subtype will show greater deficits on measures of cognitive inhibitory control, and that both types of cognitive deficit will respond to drug treatment.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboPlacebo |
| 2 | Experimental | Drug: methylphenidatemethylphenidate |
Who may qualify
- Ages
- 7 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- A diagnosis on the structured DISC interview conducted with the parent, of ADHD, Predominantly Inattentive Type.
- Ratings by parent and by teacher corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV Inattention" on the current Conners Parent (or Teacher) Rating Scale - Long Form. The items on this scale are the inattention symptom criteria from the DSM-IV, each of which the informant is asked to rate in severity on a 4-point scale ranging in severity from 0 ("not at all") to 3 ("very much"). A score above the 93th percentile indicates that the child's score equals or exceeds that for 93% of other children of the same age (within 2 years) and gender.
- A diagnosis of ADHD, Combined type on the structured DISC interview with the parent.
- Ratings by parent and teacher each corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV attention" on the current Conners Parent (Teacher) Rating Scales - Long Form.
- Ratings by parent and teacher each corresponding to a total score above the 93rd percentile (i.e. more than 1.5 SD above the mean) on the scale of "DSM-IV Hyperactive-Impulsive" symptoms on the current Conners Parent (Teacher) Rating Scales - Long Form.
Key exclusion criteria (7 listed)
- Scores more than 1 SD (84th percentile) above the mean on the DSM-IV-Hyperactive-Impulsive scale on the Conners Parent or Teacher Rating Scales-Long Form.
- WISC-III full-scale IQ less than 80.
- Major acute or chronic medical condition, including sensory loss, and neurological disorder, or any medical condition that would preclude the use of stimulant medication.
- Comorbidity: The study rationale for inclusion/exclusion of comorbid psychological/psychiatric conditions is as follows: children for whom the study treatment is contraindicated, or for whom treatment not provided in the study is required immediately, will not be entered in the trial. Thus, as an example, comorbid depression or anxiety disorder is permitted provided immediate treatment of the depressive or anxiety disorder is not required. Tic disorders of mild to moderate severity, and stable, would be eligible for inclusion, as this would not constitute a contraindication to receiving stimulants. However, children with pronounced or unstable tics would not be eligible for the trial.
- Children with any of the following conditions will be excluded from the study: psychosis, any pervasive developmental disorder, and bipolar disorder. Thus children will be permitted in the study if they have a comorbid learning disability, oppositional defiant disorder, or conduct disorder. The Wechsler Individual Achievement Tests will be administered in order that we can characterize our sample with respect to the presence of comorbid learning disabilities.
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 |
|---|---|---|
| methylphenidate(15 mg daily), medium (25 mg daily) and high (40 mg daily) | Drug | 2 |
| Placebo | Drug | 1 |
Primary outcome
(BLIND) CLINICIAN RATING ON ADHD-RS (SYMPTOM CHECKLIST) AND CGI (CLINICAL GLOBAL IMPRESSIONS)
Time frame: Weekly
1 secondary outcome
WEEKLY RATINGS BY PARENTS AND TEACHERS ON WELL-NORMED MEASURES OF ADHD SYMPTOMS AND FUNCTIONAL IMPAIRMENT PREVIOUSLY SHOWN TO BE DRUG-SENSITIVE (CONNERS AND SKAMP SCALES).
Time frame: Weekly
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 16 Jan 2009.
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Mary Solanto principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing methylphenidate in people with ADHD, run by Icahn School of Medicine at Mount Sinai 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 7 inclusion and 7 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 16 Jan 2009. 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. 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.
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?
(BLIND) CLINICIAN RATING ON ADHD-RS (SYMPTOM CHECKLIST) AND CGI (CLINICAL GLOBAL IMPRESSIONS) (time frame: Weekly). 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 16 Jan 2009.