What side effects are associated with this type of intervention?

Common treatments for ADHD, such as stimulant medications (e.g., Adderall XR) and non-stimulant medications (e.g., atomoxetine), have known side effects. Stimulants can cause insomnia, decreased appetite, weight loss, increased heart rate, and potential cardiovascular issues. Non-stimulants like atomoxetine may lead to increased heart rate, elevated blood pressure, gastrointestinal issues, and potential liver damage. Centanafadine QD XR, a triple reuptake inhibitor, may exhibit similar side effects, including insomnia, appetite suppression, gastrointestinal disturbances, and cardiovascular effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of ADHD, including stimulants like methylphenidate and amphetamines, which primarily increase dopamine and norepinephrine levels. Non-stimulant medications such as atomoxetine, a selective norepinephrine reuptake inhibitor, and guanfacine, an alpha-2-adrenergic agonist, have also been approved. While there are no current FDA-approved triple reuptake inhibitors specifically for ADHD, Centanafadine QD XR is being studied for its potential to affect dopamine, norepinephrine, and serotonin, offering a novel approach to ADHD treatment.

What other types of research exist?

Promising novel alternatives to Centanafadine QD XR for ADHD treatment include Guanfacine Extended-Release (GXR) and Atomoxetine. Guanfacine XR has shown efficacy in reducing ADHD symptoms and is particularly noted for its benefits in children with comorbid conditions like oppositional defiant disorder. Atomoxetine, a selective norepinephrine reuptake inhibitor, is another effective non-stimulant option for ADHD management.

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Norepinephrine-Dopamine Reuptake Inhibitor

Centanafadine for ADHD

Phase 3

Recruiting

Research Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial will test if centanafadine, a daily extended-release medication, can help children aged 4 to 12 years with ADHD by balancing brain chemicals to improve focus and reduce hyperactivity. Centanafadine is being investigated for the treatment of ADHD.

Who is the study for?

This trial is for boys and girls aged 4 to 12 with ADHD, confirmed by specific diagnostic criteria. They must have a certain level of symptom severity and not be undergoing recent or upcoming changes in psychological treatments. Children with severe other mental health conditions or at risk of suicide are excluded.

What is being tested?

The trial tests the effectiveness and safety of centanafadine capsules compared to placebo in treating children's ADHD symptoms. It includes a screening period, a double-blind treatment phase where neither doctors nor patients know who gets the real medicine, and follow-up.

What are the potential side effects?

While the side effects aren't specified here, common ones for ADHD medications can include sleep problems, decreased appetite, mood swings, increased blood pressure and heart rate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Weight Based Low Dose Centanafadine CapsulesExperimental Treatment1 Intervention

Cohort 1, (6 to 12 years of age) Low dose - weight-based dosing

Group II: Weight Based High Dose Centanafadine CapsulesExperimental Treatment1 Intervention

Cohort 1, (6 to 12 years of age) Cohort 2, (4 to 5 years of age) High dose - weight-based dosing

Group III: Matching PlaceboPlacebo Group1 Intervention

Cohort 1 and Cohort 2 Children (4 to 12 years of age, inclusive) to receive Placebo capsules will be matching in size and color.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for ADHD include stimulant medications such as methylphenidate and amphetamines, which increase the levels of dopamine and norepinephrine in the brain by inhibiting their reuptake. This helps improve attention and reduce hyperactive and impulsive behaviors. Non-stimulant options like atomoxetine work by selectively inhibiting the reuptake of norepinephrine, while alpha-2 adrenergic agonists like guanfacine and clonidine modulate the release of norepinephrine and improve working memory and impulse control. Centanafadine, a triple reuptake inhibitor, affects dopamine, norepinephrine, and serotonin, potentially offering a broader spectrum of symptom control by enhancing neurotransmitter balance. Understanding these mechanisms is crucial for tailoring treatment to individual ADHD patients, optimizing symptom management, and minimizing side effects.

Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies.