A Randomized Controlled Trial of Methylphenidate Transdermal System (Daytrana), Lisdexamfetamine Dimesylate (Vyvanse), OROS MPH (Concerta), and Mixed Amphetamine Salts Extended Release (Adderall XR) in Children and Adolescents With ADHD
Overview
- Phase
- Phase 4
- Intervention
- Methylphenidate transdermal system
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Sponsor
- Duke University
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
This study will determine whether two new psychostimulant medications are more effective, tolerable, and acceptable than two older medications for treating attention deficit hyperactivity disorder.
Detailed Description
Attention deficit hyperactivity disorder (ADHD) is characterized by impulsiveness, hyperactivity, and inattention. It is seen primarily in children and adolescents and is often treated with psychostimulant medications. Osmotic-release oral system (OROS) methylphenidate, brand name Concerta, and mixed amphetamine salts extended release, brand name Adderall XR, are psychostimulant medications that have shown both efficacy (that they can have therapeutic benefits) and effectiveness (that they typically have therapeutic benefits in practice). Two newer psychostimulant medications-lisdexamfetamine dimesylate, brand name Vyvanse, and methylphenidate transdermal system, brand name Daytrana-have shown efficacy but have not been tested for effectiveness, nor have they been tested head-to-head against the older psychostimulants. This study will test the effectiveness, tolerability (lack of side effects), and acceptability (ease of use for patients) of the two newer psychostimulant medications and compare them to each other and to the two older psychostimulants. Participation in this study will last 6 weeks, although some treatments may continue past the end of the study. At enrollment, participants will undergo a series of baseline evaluations. These will include interviews and assessments of ADHD symptoms, concurrent psychiatric disorders, medical and psychiatric history, family history of mental illness, risk and protective factors, other treatments, treatment expectancy of both the youth and parent, and vital signs. In consultation with their doctors, participants will be allowed to exclude zero, one, or two of the study medications; if they choose to exclude both of the new ADHD medications, they will not able to participate in the study. Participants will then be randomly assigned to one of the treatments they choose to include. They will receive a prescription for the medication and instructions for how to use it from their doctors; the study protocol does not specify a particular treatment regimen. Participants will undergo a second set of evaluations after 6 weeks of treatment or before, if the treatment ends earlier. This will include interviews and assessments similar to those administered at baseline as well as evaluation of any medication side effects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Meets DSM-IV diagnostic criteria for ADHD combined, hyperactive/impulsive, or inattentive subtype
- •Outpatient at study entry
- •Speaks English
- •Willing to be randomly assigned to one of the study treatment options as outlined in the protocol
- •No known significant history of cardiovascular disorders, including pre-existing congenital heart disease, structural heart disease, known clinically significant electrocardiogram (ECG) abnormality, or other clinically significant cardiac disorder
- •Willing to initiate study medication for ADHD within 7 days of the study baseline visit
- •May be receiving stable treatment with other drug for a comorbid disorder, defined as no changes in dose or form of drug treatment for at least 2 weeks prior to the study enrollment visit
- •May be receiving psychosocial interventions for ADHD or a comorbid disorder, defined as no changes in form of psychosocial treatment for at least 4 weeks prior to the study enrollment visit
Exclusion Criteria
- •Hypersensitivity to study medication
- •Inpatient status at study entry
- •Currently taking another medication for ADHD, including another psychostimulant, atomoxetine, or bupropion
- •Receiving treatment with a tricyclic antidepressant at study enrollment, with the exception of low-dose imipramine for enuresis or amitriptyline for chronic pain
- •Received treatment with a monoamine oxidase inhibitor (MAOI) within the past 30 days
- •Psychostimulant drug dependence, bipolar disorder, or schizophrenia
- •Presence of psychosis
- •Severe mental retardation
- •Autism or Asperger's syndrome
- •Active suicidal ideation
Arms & Interventions
1
Participants will receive methylphenidate transdermal system.
Intervention: Methylphenidate transdermal system
2
Participants will receive lisdexamfetamine dimesylate.
Intervention: Lisdexamfetamine dimesylate
3
Participants will receive osmotic-release oral system methylphenidate (OROS MPH).
Intervention: Osmotic-release oral system methylphenidate (OROS MPH)
4
Participants will receive mixed amphetamine salts extended release.
Intervention: Mixed amphetamine salts extended release
Outcomes
Primary Outcomes
Dichotomized Clinical Global Impression-Effectiveness (CGI-E) Scale
Time Frame: Measured at each participant's last visit, which can occur at or before Week 6
The CGI-E is the value at which the participant's Therapeutic Benefit and Adverse Impact to the study drug intersect. This number is determined by combining each participant's scores for the degree of Therapeutic Benefit versus the degree to which problems with Tolerability and/or Acceptability adversely impact the subject. Participants are then determined to be Responders or Non-responders to the study medication. For example, a subject who is very much improved (CGI-I=1) or much improved (CGI-I=2) therapeutically and whose adverse impact rating is none (score 1,5) or mild (score 2,6) will be categorized as a Responder. All others whose adverse impact rating is moderate (score 3,7,11,15)or outweighs therapeutic effect (score 4,8,12,16) will be categorized as Non-responders to study medication. The CGI scores are totaled for each participant and a mean score is calculated. A median total score was calculated for each treatment group.
Secondary Outcomes
- Clinical Global Improvements-Acceptability (CGI-A) Scale(Measured at each participant's last visit, which can occur at or before Week 6)
- Clinical Global Impressions-Improvement (CGI-I) Scale(Measured at each participant's last visit, which can occur at or before Week 6)