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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT00824317
Study groupRoleWhat they receive
1Placebo comparatorPlacebo
Receives: Drug: Placebo
2Experimentalmethylphenidate
Receives: Drug: methylphenidate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. (BLIND) CLINICIAN RATING ON ADHD-RS (SYMPTOM CHECKLIST) AND CGI (CLINICAL GLOBAL IMPRESSIONS)

    Measured: Weekly

Secondary outcomes (1)
  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.

  1. First posted16 Jan 2009 (estimated)
  2. Study startOct 2001
  3. Primary completionFeb 2005
  4. Study completionFeb 2005

Resources

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)
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

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.

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