Adderall Study Database
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Visual Abstract
Long-term tolerability and effectiveness of once-daily mixed amphetamine salts (Adderall XR) in children with ADHD
Adderall XR Shows Lasting ADHD Symptom Improvement Over Two Years
October 7, 2024
author
McGough JJ, Biederman J, Wigal SB, Lopez FA, McCracken JT, Spencer T, Zhang Y, Tulloch SJ
journal
J Am Acad Child Adolesc Psychiatry
Date Published
2005 Jun
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Study Summary
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What They Studied
The main research question was to evaluate the long-term tolerability and effectiveness of Adderall XR in children with ADHD.
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What They Found
The study found that Adderall XR significantly improved behavior in children with ADHD over 24 months, with mild adverse effects.
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What This Means
These findings suggest that Adderall XR aligns with current evidence by effectively treating ADHD, as it improved attention and reduced impulsivity with a well-tolerated profile in children.
Study Summary
Study Overview
The study aimed to explore how well a long-term ADHD treatment works and how safe it is for children. Researchers followed children over two years to see if the medication could consistently control ADHD symptoms without causing serious side effects. They found that the treatment was both effective and well-tolerated, helping kids manage their symptoms over the long term while minimizing adverse effects. This study adds to our understanding of how extended treatment can benefit children with ADHD.
Abstract: background
To evaluate the long-term tolerability and effectiveness of extended-release mixed amphetamine salts (MAS XR; Adderall XR) in children with attention-deficit/hyperactivity disorder (ADHD).
Long-Term Tolerability and Effectiveness
"Long-term tolerability and effectiveness of MAS XR were demonstrated in children with ADHD in this 2-year, open-label extension of two previous placebo-controlled studies."
Persistent Clinical Benefits
"The current study demonstrated that long-term MAS XR treatment was both well tolerated and provided persistent, robust clinical benefits."
Impact on Growth Measures
"For all growth measures, including weight, height, and body mass index (kg/m2), the reduction in expected growth was not significant in the second year of the study."
Study Summary
Methods
The study involved 568 children aged 6 to 12 years who were already part of two earlier trials. These children began taking a daily dose of 10 mg of Adderall XR, with doses gradually increased to find the most effective amount, up to a maximum of 30 mg per day.
Researchers monitored the children’s behavior using a tool called the Conners Global Index Scale and kept track of side effects, vital signs, and any changes in physical health through regular exams and lab tests.
Researchers monitored the children’s behavior using a tool called the Conners Global Index Scale and kept track of side effects, vital signs, and any changes in physical health through regular exams and lab tests.
Abstract: methods
This was a 24-month, multicenter, open-label extension of TWO placebo-controlled studies of MAS XR in children with ADHD aged 6 to 12 years. Subjects (N=568) began treatment with MAS XR 10 mg once daily, with 10-mg weekly dose increases to optimal ef...more
Study Summary
Results
The study found that the children's behavior improved significantly, with scores on the behavioral scale improving by over 30%. These improvements were maintained throughout the two years. The medication was generally well tolerated, with most side effects being mild, such as loss of appetite, trouble sleeping, and headaches.
However, it was noted that higher doses were linked to more side effects, indicating that the dose played a role in how the drug affected the children. Changes in lab results and vital signs were minor and didn’t raise any major health concerns.
However, it was noted that higher doses were linked to more side effects, indicating that the dose played a role in how the drug affected the children. Changes in lab results and vital signs were minor and didn’t raise any major health concerns.
Abstract: results
Significant improvements (>30%, p < .001) in CGIS-P scores were maintained during long-term treatment. Treatment was well tolerated, and most AEs were mild. The most frequently reported drug-related AEs included anorexia, insomnia, and headache. The ...more
Study Summary
Conclusions
In summary, this study showed that daily doses of 10 mg to 30 mg of Adderall XR are effective and generally safe for children with ADHD. Behavioral improvements were consistent over two years of treatment.
While some side effects were observed, they were mostly mild and manageable, reinforcing the drug's potential as a long-term treatment option for managing ADHD in children.
While some side effects were observed, they were mostly mild and manageable, reinforcing the drug's potential as a long-term treatment option for managing ADHD in children.
Abstract: conclusions
In children with ADHD, once-daily 10 mg-30 mg MAS XR was well tolerated and significant behavioral improvements were consistently maintained during 24 months of treatment.
Background Information
Patient Guide
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Adderall: A Comprehensive ADHD Treatment
Adderall is FDA-approved for ADHD, aiding in attention and impulse control management.
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Long-term Side Effects of CNS Stimulants
Chronic use of CNS stimulants like Adderall may change brain chemistry or lead to dependence.
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Vital Monitoring for Adderall Users
Regular monitoring includes cardiac evaluations and checking for potential growth suppression in children.
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Risks and Contraindications
Adderall should not be used in patients with heart disease, MAOI therapy, or a history of drug misuse.
Professional Guide
Expert Opinion: Adderall XR Shows Lasting ADHD Symptom Improvement Over Two Years
In line with the findings on tolerability, current recommendations emphasize careful monitoring when initiating amphetamine treatment, particularly in patients with pre-existing cardiovascular issues. Cardiovascular assessments are necessary to rule out contraindications, as stimulants like Adderall may exacerbate behavioral disturbances in those with psychotic disorders. Additionally, clinicians should remain vigilant for treatment-emergent psychotic symptoms in children and adolescents without prior history of such conditions. Consistent with the study's focus on long-term treatment, there is an associated risk of growth suppression, including a potential reduction in final adult height. Furthermore, when prescribing extended-release formulations, clinicians might need to address the waning effects in the afternoon with supplemental immediate-release doses.
Evidence Summary
Tracking Growth with Long-Term MAS-XR Use
Examining the impact of MAS-XR, the focus shifts to how this medication affects children's growth, particularly their height and weight, when used long-term. Clinical trials trace physical growth patterns in children diagnosed with ADHD on MAS-XR. These findings emphasize continuous monitoring to understand how treatment influences physical development over time.
Evidence Summary
Comparing ADHD Medications: Safety and Efficacy Insights
A detailed look at ADHD medications reveals how they work and how well patients manage side effects. By comparing studies, we gain insights into both the effectiveness and safety of various treatments. This comprehensive approach helps to present a balanced understanding of what patients and caregivers can expect from different medications.
Reviewing the results across studies helps form a broader picture of treatment outcomes, with a focus on patient safety and therapeutic success.
Reviewing the results across studies helps form a broader picture of treatment outcomes, with a focus on patient safety and therapeutic success.
Evidence Summary
Adderall XR vs. Strattera: A Comparative Analysis
Adderall XR and Strattera, two common ADHD medications, are compared for their impact on children's attention and behavior at school. This insight helps in understanding how both medications perform in real-world settings. Adderall XR, discussed extensively in the broader study, shares the stage with Strattera, providing a side-by-side look at their respective benefits and drawbacks.
Evidence Summary
Adderall XR: Improving Focus and Behavior in Children with ADHD
Exploring the daily use of Adderall XR in children with ADHD reveals the medication's role in enhancing attention and behavior. A focused study assesses its effectiveness and safety, providing insight into how it helps manage symptoms. With once-a-day dosage, the article details improvements in focus and conduct, supporting findings on both its beneficial effects and any reported side effects.
