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ADHD NOSPhase 4NCT00181740

Concerta Treatment in Adults With ADHD NOS

A Phase 4 study testing atomoxetine (Strattera) in people with ADHD NOS, run by Massachusetts General Hospital 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

This will be an open label pilot study of Concerta in the treatment of adults with the diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS). We hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Concerta treatment in the short term and Concerta-associated… Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
ADHD NOS
What is being tested?
atomoxetine (Strattera)
How many people
30 participants
Where
1 siteUnited States
Study dates
Dec 2003to Jul 2005
Phase
Phase 4
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 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Male and female outpatients older than 18 and younger than 55 years of age.
  • Subjects with the diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview. This is operationalized by either
  • Having at least 5 out of 9 current DSM-IV items of either inattention or hyperactivity/impulsivity but < 5 items from either list in childhood
  • Having 5 out of 9 current DSM-IV items of either inattention or hyperactivity/impulsivity, but not having the 6 current symptoms in either category. This second category will be included independent of the presence or absence of ADHD symptoms in childhood.
  • Subjects will have a current Clinical Global Impression: ADHD score of 4 (moderately ill) or higher illness severity.
  • Patients with past history of depression, bipolar disorder, anxiety disorder (including OCD) without current disorder for > 3 months as ascertained through structured diagnostic interview and clinical exam.
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  • Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least three months, and who have a disorder specific CGI-severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-anxiety rating scale below 15 (mild range) will be included in the study.
  • Subjects with a past history of tics but tic free for > 1 year.
  • Subjects with past history of substance use disorders, but substance free for > 6 months.
  • Subjects receiving non-MAOI antidepressants (e.g., SSRI's, bupropion, venlafaxine), or benzodiazepines who have been on a stable regimen for > 3 months for any of the conditions listed above. Subjects taking SSRIs will be allowed into the study for the following reasons:
  • SSRIs are not known to interact with methylphenidate
  • Methylphenidate metabolism does not involve the hepatic P450 enzymatic system
  • SSRIs have extremely wide margins of safety
  • SSRIs and methylphenidate are combined routinely in clinical practice.
  • Subjects with mild cases of asthma and allergy will not be excluded.
  • Subjects with acid reflux syndrome will not be excluded.
  • Subjects with hypercholesterolemia will not be excluded.

Who cannot join

  • Any clinically unstable psychiatric conditions including the following: acute psychosis, acute panic, acute OCD, acute mania, acute suicidality, bipolar disorder, acute substance use disorders (alcohol or drugs), acute OCD, sociopathy, criminality.
  • Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease.
  • Clinically significant abnormal baseline laboratory values which include the following:
  • Values larger than 20% above the upper range of the laboratory standard of a basic metabolic screen.
  • Exclusionary blood pressure parameters will include any values above 140 (systolic) and 90 (diastolic).
  • Exclusionary ECG parameters will include a QTC> 460msec, QRS>120 msec, and PR>200 msec. Subjects having ECG evidence of ischemia or arrhythmia as reviewed by an independent cardiologist.
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  • Mental retardation (I.Q. <75).
  • Organic brain disorders.
  • Seizures or tics in the last year.
  • Subjects with a family history or diagnosis of Tourette's syndrome.
  • Subjects who are being treated with monoamine oxidase inhibitors, or have stopped treatment of monoamine oxidase inhibitors for less than 14 days prior to baseline visit.
  • Subjects taking coumadin anticoagulants, anticonvulsants, or tricyclic antidepressants.
  • Pregnant or nursing females.
  • Subjects with current adequate treatment for ADHD or a history of a previous adequate trial of Concerta.
  • Non English speaking subjects will not be allowed into the study for the following reasons:
  • The assessment instruments are not available and have not been adequately standardized in other languages
  • Our clinical trials facility is located in Cambridge and not in the MGH main campus without the availability of translators
  • Psychiatric questionnaires and evaluations are taxing and adding the complexity of a translator has the potential to make the patient experience even more exhausting.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Cambridge, Massachusetts, 02138

Other trials in United States

About this study

Official title: A Pilot Study of Concerta Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified

This will be an open label pilot study of Concerta in the treatment of adults with the diagnosis of Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS). We hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to Concerta treatment in the short term and Concerta-associated response of ADHD symptomatology in adults with ADHD NOS will be sustained over the medium term.

Read the detailed description

Concerta is a stimulant medication approved for the treatment of ADHD in children. We propose to study the safety and efficacy of Concerta therapy in adults with ADHD NOS. Adult ADHD NOS is operationalized by either

  • An adult satisfying current diagnostic criteria for ADHD but with insufficient number of childhood symptoms to fulfill the required diagnostic threshold for this disorder set forth in DSM-IV
  • An adult who has five current symptoms of inattention and/or five current symptoms of impulsivity/hyperactivity, but does not meet the full diagnosis criteria of six current symptoms within one of these categories.

Our hypotheses will be examined in two phases of an open label, pilot study. Phase I of the study consists of a six-week acute effectiveness trial. Phase II consists of continuation for responders in which subjects who respond in Phase I will be re-assessed every four weeks for six months. Effectiveness will be measured by improvements in clinician-rated scales, including: ADHD Symptom Checklist, Clinical Global Impression: ADHD, and Global Assessment of Functioning.

Conditions
ADHD NOS
Being tested
atomoxetine (Strattera)
Keywords
ADHD NOS, Adults, Concerta, Open-Label

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • atomoxetine (Strattera)Drug

What is being measured

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

  1. improvement of ADHD symptoms as related by scores on the

  2. ADHD Symptom Checklist

  3. Clinical Global Impression: ADHD

  4. Global Assessment of Functioning

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2005 (estimated)
  2. Study startDec 2003
  3. Study completionJul 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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00181740
Sponsor's protocol ID
2003-P-001355
Status last verified
Jul 2010
First submitted
13 Sep 2005
Last updated
23 Jul 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing atomoxetine (Strattera) in people with ADHD NOS, run by Massachusetts General Hospital 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 17 inclusion and 18 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 23 Jul 2010. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

improvement of ADHD symptoms as related by scores on the. The study lists 4 primary outcomes in all. 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 NCT00181740.

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 23 Jul 2010.

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