Guanfacine vs Methylphenidate for ADHD
(TYCA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the effectiveness of two medications, Guanfacine and Methylphenidate, in treating ADHD in young children. Researchers aim to determine which drug more effectively improves behavior after children have undergone behavioral therapy. Suitable candidates have moderate or severe ADHD and have not yet taken these specific medications. The trial targets children aged 3 to 5 who speak English or Spanish at home. As a Phase 4 trial, this research seeks to understand how these FDA-approved treatments can benefit a broader range of patients.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any current ADHD medications or other psychotropic medications before joining the trial.
What is the safety track record for these treatments?
Research has shown that Guanfacine is generally safe for children with ADHD. Studies have found that children taking Guanfacine usually do not experience serious side effects. Some children might feel sleepy or tired, but these effects are typically mild.
For Methylphenidate, research suggests it is also safe for long-term use in children with ADHD. Most side effects are not serious and can include trouble sleeping or a reduced appetite. However, one study noted that Methylphenidate might cause more minor side effects than not taking it.
Both treatments have been used in children and are considered safe, but monitoring for any side effects is important. Always consult a doctor if there are concerns about these treatments.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for ADHD because they offer distinct approaches compared to traditional options like amphetamine-based medications. Guanfacine is unique as it targets the alpha-2A adrenergic receptors in the brain, which helps improve attention and reduce impulsivity without relying on stimulant pathways. In contrast, Methylphenidate works by increasing dopamine and norepinephrine levels in the brain, providing an alternative to amphetamines with a different side effect profile. These differences could offer more tailored treatment options for those who do not respond well to conventional ADHD medications or who experience undesirable side effects.
What evidence suggests that this trial's treatments could be effective for ADHD?
This trial will compare Guanfacine and Methylphenidate for treating ADHD. Studies have shown that both medications effectively treat ADHD symptoms. Participants may receive Guanfacine, which significantly reduces ADHD symptoms; one study found it 75% more effective than a placebo. On average, it can lower scores on the ADHD Rating Scale by 17 to 21 points. Alternatively, participants may receive Methylphenidate, which also reduces key ADHD symptoms and improves daily functioning. Research has shown that Methylphenidate improves ADHD symptoms as rated by teachers and enhances overall quality of life compared to a placebo. Both medications have strong evidence supporting their use in managing ADHD.24567
Are You a Good Fit for This Trial?
This trial is for boys and girls aged 3 to 5 with moderate or severe ADHD, as confirmed by DSM-5 criteria. They must have significant impairment from their symptoms and be candidates for drug therapy with either Methylphenidate or Guanfacine. Children must speak English or Spanish.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Methylphenidate or Guanfacine for ADHD treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Guanfacine
- Methylphenidate
Trial Overview
The study compares the effectiveness of two ADHD medications in young children: Methylphenidate (commonly known as Ritalin) versus Guanfacine. It measures how much each medication helps improve behavior, based on clinician ratings.
How Is the Trial Designed?
2
Treatment groups
Active Control
After engaging in behavioral therapy, participants randomized to this group will be prescribed Guanfacine. The child's prescribing clinician will determine the form and dose of Guanfacine that the child receives.
After engaging in behavioral therapy, participants randomized to this group will be prescribed Methylphenidate. The child's prescribing clinician will determine the form and dose of Methylphenidate that the child receives.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Children's Hospital of Philadelphia
Collaborator
Developmental Behavioral Pediatrics Research Network
Collaborator
Boston Children's Hospital, Boston, MA, USA
Collaborator
Children's Mercy Hospital Kansas City
Collaborator
Stanford University
Collaborator
Citations
Evaluating Guanfacine Hydrochloride in the Treatment of ...
Compared with placebo, GXR treatment showed a significant decrease in ADHD-RS total score. Additionally, treatment with GXR showed significantly ...
2.
adhdevidence.org
adhdevidence.org/blog/updated-meta-analysis-supports-efficacy-of-guanfacine-in-treating-adhdUpdated Meta-analysis Supports Efficacy of Guanfacine in ...
Meta-analysis of all eleven studies with a combined total of 2,623 participants found guanfacine to be roughly 75% more effective than placebo ...
Efficacy and safety of extended-release guanfacine ...
This study assessed the efficacy (symptoms and function) and safety of dose-optimized GXR compared with placebo in children and adolescents with ADHD.
Guanfacine (Intuniv) for Attention-Deficit/Hyperactivity ...
Dosages of 1 to 4 mg per day decrease scores on the ADHD Rating Scale-IV by an average of 17 to 21 points, compared with a decrease of 9 to 12 ...
Comprehensive analysis of Guanfacine treatment in autism ...
Guanfacine XR, a non-stimulant ADHD medication, shows promise for managing hyperactivity and irritability in ASD-ADHD but with mixed results.
Comparative efficacy and safety of attention-deficit ...
This study compared the clinical efficacy and safety of attention-deficit/hyperactivity disorder (ADHD) pharmacotherapy in children and adolescents 6–17 ...
Maintenance of Efficacy of Extended-Release Guanfacine ...
The primary objective of this study is to evaluate the long-term maintenance of efficacy of Extended-Release Guanfacine HCl in children and adolescents ...
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