NRCT-101SR for Attention Deficit Hyperactivity Disorder (ADHD)

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Attention Deficit Hyperactivity Disorder (ADHD)NRCT-101-SR - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The goal of this clinical trial is to evaluate the efficacy and safety of NRCT-101SR compared to placebo in adult patients with ADHD aged 18 years and older.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Week 6

Week 6
Change from Baseline Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)
Change from Baseline in ADHD Investigator Symptom Rating Scale (AISRS)
Change from Baseline in Adult ADHD Quality of Life scale (AAQoL)
Change from Baseline in Hospital Anxiety and Depression Scale (HADS)
Change from Baseline in Permanent Product Measure of Performance (PERMP) - Number of Math Problems Answered Correctly (PERMP-C)
Change from Baseline in the ADHD Investigator Symptom Rating Scale - Expanded Version (AISRS-EV)
Change from Baseline in the Clinical Global Impression - Severity (CGI-S)
Responder Rate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

NRCT-101SR
1 of 2
Matching Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

216 Total Participants · 2 Treatment Groups

Primary Treatment: NRCT-101SR · Has Placebo Group · Phase 2 & 3

NRCT-101SR
Drug
Experimental Group · 1 Intervention: NRCT-101-SR · Intervention Types: Drug
Matching Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 6

Who is running the clinical trial?

Neurocentria, Inc.Lead Sponsor
4 Previous Clinical Trials
99 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
20 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)

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must possess proficient English proficiency and be able to read, write, communicate effectively with others and volunteer for laboratory classroom activities.
You have finished at least a decade of formal schooling.
You are capable of providing informed consent.
You are at least 18 years old.
You have been clinically diagnosed with ADHD as per DSM-5 criteria and verified using MINI diagnostic probes.
Your AISRS score must be at least 26 at both screening and baseline, with no more than a 25% change in said score (unless you stopped taking ADHD medication after screening where an increase of over 25% is accepted).
You must have achieved a score of at least 4 on the CGI-S initially.
You possess adequate aural and visual aptitude to carry out cognitive testing, in the investigator's estimation.
Your total body weight must be between 50 and 105 kilograms, with a lean body mass not exceeding 75 kilograms, at the time of screening.
You are unfamiliar with stimulant or non-stimulant medications used to treat ADHD, and have stopped taking stimulants at least two weeks before randomization, and non-stimulants at least three weeks prior.