Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder
Recruitment status was Recruiting
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | January 29, 2007 | ||||||||
| Last Updated Date | October 5, 2010 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Score on ADHD IV Rating Scale (ADHD-RS) [ Time Frame: Measured at baseline and Weeks 0 to 8 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Score on ADHD IV Rating Scale (ADHD-RS) (measured at Month 14) | ||||||||
| Change History | Complete list of historical versions of study NCT00429273 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Score on behavioral ratings CGI-Improvement, Conners Global Index and cognitive test measures [ Time Frame: Measured at baseline and Weeks 0 to 8 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
|
||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder | ||||||||
| Official Title ICMJE | An Eight-Week, Randomized, Double-Blind Comparison of Guanfacine, Focalin XR, and the Combination, With a Twelve Month Open-Label Extension for the Treatment of ADHD in Pediatric Subjects Aged 7 to 14 Years | ||||||||
| Brief Summary | This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children. |
||||||||
| Detailed Description | Attention deficit hyperactivity disorder (ADHD) is one of the most common childhood mental disorders. Children with ADHD have impaired functioning in multiple settings, including home and school. They also have difficulty relating with peers. If left untreated, the disorder may cause adverse effects that can last into adolescence and adulthood. Stimulant medications, such as methylphenidate, are effective in reducing ADHD symptoms on a short-term basis. However, few long-term benefits in academic or general functioning from current ADHD therapies have been demonstrated. Focalin XR is a stimulant medication that is FDA-approved for treating ADHD. Guanfacine is another medication that is currently approved for the treatment of hypertension, but has long been used for treating ADHD. This study will determine the effectiveness of a combination of Focalin XR and guanfacine in enhancing cognitive functioning and improving the long-term benefit of ADHD treatment. Participants in this study will be randomly assigned to one of three treatment regimens: Focalin XR and placebo; guanfacine and placebo; or Focalin XR and guanfacine. The study will be conducted in two phases: an 8-week double-blind treatment phase and a 12-month open-label treatment phase. In Phase I, one third of participants will receive placebo for the initial 4 weeks, followed by Focalin XR alone for the remaining 4 weeks. All other participants will receive their assigned medications for the full 8 weeks. All participants will attend two study visits prior to beginning treatment and one study visit per week throughout Phase I. At the end of Phase I, treatment assignments will be unblinded. Participants who experienced adequate improvement with their assigned treatment will then continue in Phase II on the same medication(s) for an additional 12 months. Participants will attend study visits once per month until the end of the study. Study visits will include self-report measures, clinical assessments, and cognitive testing. Participants will also undergo four electroencephalography (EEG) tests and two fMRI scans over the course of the study. All Phase II participants will receive a follow-up telephone call 1 month after the final study visit. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Attention Deficit Disorder With Hyperactivity | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 180 | ||||||||
| Estimated Completion Date | July 2011 | ||||||||
| Estimated Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 7 Years to 14 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00429273 | ||||||||
| Other Study ID Numbers ICMJE | P50 MH077248-01, DDTR B2-NDH | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | James McCracken, MD, UCLA | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | October 2008 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||