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Methylphenidate Hydrochloride ER + Behavioral Classroom + Academic Accommodations for ADHD

Phase 4
Recruiting
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ADHD Diagnosis
IQ >= 70
Must not have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upthrough study completion, a maximum of eight weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Study Summary

This trial is testing if different treatments, alone or combined, help kids with ADHD in school. It will look at things like how well they pay attention and how productive they are.

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with ADHD.
Select...
You must have an IQ score of at least 70.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, a maximum of eight weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, a maximum of eight weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Behavioral frequency count of rule violations
Quiz Scores
Seatwork completion

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Positive Behavior Support ClassroomExperimental Treatment3 Interventions
Positive Behavior Support Classroom procedures
Group II: Methylphenidate ER (.3 mg/kg dose)Experimental Treatment3 Interventions
Methylphenidate ER (.3 mg/kg dose)administered in the morning
Group III: Academic accommodationsExperimental Treatment4 Interventions
Academic accommodations are used during seat work and quiz
Group IV: General ClassroomActive Control3 Interventions
General classroom procedures
Group V: PlaceboPlacebo Group3 Interventions
Placebo capsule administered in the morning
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Florida International UniversityLead Sponsor
99 Previous Clinical Trials
16,922 Total Patients Enrolled
16 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
2,033 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)

Media Library

Behavioral classroom Clinical Trial Eligibility Overview. Trial Name: NCT05469386 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Placebo, Methylphenidate ER (.3 mg/kg dose), General Classroom, Positive Behavior Support Classroom, Academic accommodations
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: Behavioral classroom Highlights & Side Effects. Trial Name: NCT05469386 — Phase 4
Behavioral classroom 2023 Treatment Timeline for Medical Study. Trial Name: NCT05469386 — Phase 4
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT05469386 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the academic modifications provided to individuals secure?

"The safety of Academic Accommodations has been established in previous clinical trials, so it receives a rating of 3."

Answered by AI

To what extent can individuals partake in this clinical trial?

"This clinical trial is searching for 288 individuals with Attention Deficit Hyperactivity Disorder (ADHD), aged 5 to 12. To be considered eligible, prospective participants must meet the conditions outlined above."

Answered by AI

How many participants are engaged in this experiment?

"Affirmative. The clinicaltrials.gov database indicates that this trial, which was initially posted on June 13th 2022, is actively enrolling patients. Over the course of two sites, 288 participants are required for completion of the study."

Answered by AI

Is the age limit for participation in this research project above 30 years old?

"For this particular study, the eligible age range of participants is from 5 to 12 years old."

Answered by AI

Are new participants being accepted at this time for the trial?

"Recent updates on clinicaltrials.gov indicate that this research effort, which was initially listed on June 13th 2022, is still looking for patients to partake in the study. The most recent edit occured on July 20th of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Iowa
North Carolina
Texas
How old are they?
18 - 65
What site did they apply to?
FIU Center for Childern and Families
Center for Children and Families
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
2

Why did patients apply to this trial?

I have struggled with adding my entire life. I have been interested to see if there are any better treatments out there nowadays for adhd as I'm finding it more and more difficult to cope with my condition.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom
2022. "Single and Combined Effects of Behavioral, Academic, and Medication Treatments for ADHD in the Classroom". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05469386.
All > Adhd
~159 spots leftby Aug 2025
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