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Central Nervous System Stimulant

ADHD Medications for Attention Deficit Hyperactivity Disorder (ADHD) (BAT Trial)

Phase 1
Recruiting
Led By Anne Arnett, PhD
Research Sponsored by Boston Children's Hospital
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 baseline & 3 months after trial completion
Awards & highlights

BAT Trial Summary

This trial aims to use EEG to predict how children with ADHD will respond to meds like methylphenidate & mixed amphetamine salts.

Who is the study for?
This trial is for children aged 7-11 with ADHD who haven't tried stimulant medications yet. They must be patients at the Children's Hospital Primary Care Center. Kids can't join if they have certain medical conditions like heart issues, intellectual disability, autism, a history of seizures or suicide attempts, are on other psychotropic meds, were born very premature or had prenatal substance exposure.Check my eligibility
What is being tested?
The study tests how well kids with ADHD respond to two common meds: Concerta and Adderall-XR. It uses EEG to find brain activity patterns that might predict which med works better for them. First tested with Concerta for 3 weeks; if no improvement, then tested with Adderall-XR for another 3 weeks while monitoring symptoms and side effects.See study design
What are the potential side effects?
Possible side effects from Concerta (methylphenidate) and Adderall-XR (mixed amphetamine salts) include trouble sleeping, decreased appetite, stomach pain, headaches, jitteriness and mood swings.

BAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 3 months after trial completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 3 months after trial completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline EEG Cued P3 Amplitude
Baseline EEG Novelty P3 Amplitude
Baseline EEG Resting Alpha Peak Frequency
+14 more
Secondary outcome measures
Change in Externalizing Symptoms
Change in Internalizing Symptoms
Change in Tests of Variables of Attention (TOVA) Commission errors on Adderall-XR
+11 more

BAT Trial Design

2Treatment groups
Active Control
Group I: Mixed Amphetamine Salts TrialActive Control1 Intervention
3-week trial of mixed amphetamine salts with weekly dose adjustments.
Group II: Methylphenidate TrialActive Control1 Intervention
3-week methylphenidate trial with weekly dose adjustments.

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,900 Total Patients Enrolled
6 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
1,293 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Anne Arnett, PhDPrincipal InvestigatorBoston Children's Hospital
Eugenia Chan, MDPrincipal InvestigatorBoston Children's Hospital

Frequently Asked Questions

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

Is this clinical investigation open to elderly participants?

"This study is open to all children aged between 7 and 11 years old."

Answered by AI

Are enrollees currently being accepted into this clinical experiment?

"The details of this clinical trial, which was uploaded on February 17th 2023, can be found on the website clinicaltrials.gov. It is currently in a recruitment phase and last edited its information on September 5th 2023."

Answered by AI

How many individuals are being included in the experiment?

"Affirmative. The clinicaltrials.gov database shows that this experiment is currently enrolling participants, with the initial post made on February 17th 2023 and the last update recorded September 5th 2023. This trial requires 30 individuals to be admitted at a single medical facility."

Answered by AI

Is it possible for me to participate in this research project?

"This trial seeks 30 minors who are 7-11 years old and have either been diagnosed with ADHD or referred for an evaluation. These children must be seen at the Children's Hospital Primary Care Center, and cannot have tried stimulants in the past to qualify."

Answered by AI

Has the FDA approved Methylphenidate Trial for use?

"Due to its status as a Phase 1 trial, indicating limited evidence of safety and efficacy, Methylphenidate Trial was assigned a score of 1."

Answered by AI

What core aims are being pursued through this research endeavor?

"During the 3-week Concerta trial, this study aims to assess Long-Term Clinical Global Impressions-Improvement (CGI-I) in ADHD related impairment. Secondary endpoints include Medication Tolerance to both Concerta and Adderall XR as well as Change in Tests of Variables of Attention Commission errors on Adderall XR. To measure tolerance severity, parents' and teachers' assessments will be made using the ADHD Vanderbilt Rating scales with a summary rating from 1 (no side effects) to 2 (mild side effects) or 3 (significant side effects requiring treatment discontinuation). Additionally, TOVA"

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
What site did they apply to?
2 Brookline Place

Why did patients apply to this trial?

I’m looking to get in touch with someone to help me apply for the paid trials or studies. I’m very interested and having a hard time doing this online alone. Thanks Jessica please call me 603 313 3009.
PatientReceived 1 prior treatment
~4 spots leftby Jul 2024