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Norepinephrine Reuptake Inhibitor
NRCT-101-SR for ADHD
Phase 2 & 3
Waitlist Available
Led By Ann Childress, M.D.
Research Sponsored by Neurocentria, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female, ≥ 18 years of age at screening
Has a primary diagnosis of ADHD according to the Diagnostic and Statistical Manual, Fifth Edition (DSM-5) classification, confirmed with Mini International Neuropsychiatric Interview (MINI) using DSM-5 probes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights
Study Summary
This trial will test a new treatment for adult ADHD to assess effectiveness and safety.
Who is the study for?
Adults over 18 with ADHD diagnosed by DSM-5 criteria, who have not taken ADHD medication recently. They must be fluent in English, have completed at least 10 years of education, and weigh between 50 kg and 105 kg. Participants should be able to see and hear well enough for cognitive tests.Check my eligibility
What is being tested?
The trial is testing NRCT-101SR's effectiveness and safety against a placebo in adults with ADHD. Patients will either receive the actual drug or a placebo to compare results.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects for ADHD medications can include sleep problems, decreased appetite, delayed growth in children, headaches and stomachaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have been diagnosed with ADHD according to DSM-5.
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I am fluent in English and can read, write, and communicate effectively.
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My weight is between 50 and 105 kg, and my lean body mass is 75 kg or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in ADHD Investigator Symptom Rating Scale (AISRS)
Change from Baseline in Permanent Product Measure of Performance (PERMP) - Number of Math Problems Answered Correctly (PERMP-C)
Secondary outcome measures
Change from Baseline Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Change from Baseline in Adult ADHD Quality of Life scale (AAQoL)
Change from Baseline in Hospital Anxiety and Depression Scale (HADS)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NRCT-101SRExperimental Treatment1 Intervention
Two-tiered fixed dose of 1,500 or 2,000 mg/day. Two NRCT-101SR tablets (375 mg or 500 mg based on lean body mass) by mouth twice daily
Group II: Matching PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NRCT-101-SR
2023
Completed Phase 3
~230
Find a Location
Who is running the clinical trial?
Neurocentria, Inc.Lead Sponsor
5 Previous Clinical Trials
259 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
180 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Ann Childress, M.D.Principal InvestigatorCenter for Psychiatry and Behavioral Medicine
2 Previous Clinical Trials
81 Total Patients Enrolled
2 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
81 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Guosong Liu, M.D., Ph.D.Study DirectorNeurocentria, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My weight is between 50 and 105 kg, and my lean body mass is 75 kg or less.I have been diagnosed with ADHD according to DSM-5.My family has a history of sudden heart-related deaths or irregular heartbeats.My medication doses have been stable for the last 30 days.My thyroid function is not normal, but I've been on stable thyroid medication for over 3 months.I am not pregnant or breastfeeding.My kidney function is poor, with an eGFR below 40 mL/min/m2.I have a history of serious gut issues like chronic diarrhea or Crohn's disease.You are capable of providing informed consent.I am fluent in English and can read, write, and communicate effectively.I do not have a severe physical disability that affects my ability to complete tests.I do not have any serious illness that could worsen or affect my study participation.I drink more than the specified weekly alcohol limit.I am 18 years old or older.I have never taken ADHD medication or stopped taking it at least 2-3 weeks ago.You have finished at least a decade of formal schooling.I have a history of seizures or tic disorders, but not Tourette's.I have a history of serious heart problems.My ADHD symptoms are severe and haven't improved much since my last check-up.
Research Study Groups:
This trial has the following groups:- Group 1: Matching Placebo
- Group 2: NRCT-101SR
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Attention Deficit Hyperactivity Disorder (ADHD) Patient Testimony for trial: Trial Name: NCT05683249 — Phase 2 & 3
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