What is the mechanism of action of this treatment?

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, which increase dopamine and norepinephrine levels by inhibiting their reuptake and promoting their release. Non-stimulant medications, such as atomoxetine, selectively inhibit the reuptake of norepinephrine. These treatments target neurotransmitter pathways that are often dysregulated in ADHD, helping to improve attention, focus, and impulse control. Understanding these mechanisms is important for patients as it guides treatment choices and helps manage expectations regarding efficacy and side effects.

What side effects are associated with this type of intervention?

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, and non-stimulant medications like atomoxetine. Stimulants can cause side effects such as decreased appetite, weight loss, insomnia, increased heart rate, and potential for abuse. Atomoxetine, a non-stimulant, may cause side effects including gastrointestinal issues, decreased appetite, fatigue, and potential liver damage. Both types of medications require monitoring for adverse effects to ensure safe and effective use.

What prior FDA approvals exist?

FDA-approved treatments for ADHD include stimulant medications like amphetamine (Adderall) and methylphenidate (Ritalin, Concerta), which are well-established in targeting neurotransmitter pathways. Non-stimulant options include atomoxetine (Strattera), which enhances norepinephrine, and alpha-2-adrenergic agonists like clonidine extended release (Kapvay) and guanfacine extended release (Intuniv). These medications offer alternatives for patients who may not respond well to stimulants or have contraindications.

What other types of research exist?

Promising alternatives to NRCT-101SR for ADHD treatment include Atomoxetine (Strattera), a selective norepinephrine reuptake inhibitor, and Viloxazine extended-release (Qelbree), which has shown efficacy in recent clinical trials. Both medications are non-stimulants and target neurotransmitter pathways involved in ADHD. Atomoxetine is well-documented for its safety and efficacy in children, adolescents, and adults. Viloxazine has also demonstrated positive outcomes in school-age children with ADHD.

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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

Must not have

Poor kidney function; corrected estimated glomerular filtration rate (eGFRcorr) < 40 mL/min/m2

History of significant gastrointestinal disorders, such as chronic diarrhea, irritable bowel syndrome, ulcerative colitis, Crohn's disease, etc

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6

Summary

This trial tests a new medication called NRCT-101SR to see if it helps adults with ADHD. Participants will take the medication regularly, and researchers will measure its effectiveness by looking at math test scores and symptom ratings before and after treatment.

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is poor, with an eGFR below 40 mL/min/m2.

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I have a history of serious gut issues like chronic diarrhea or Crohn's disease.

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I am not pregnant or breastfeeding.

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I do not have a severe physical disability that affects my ability to complete tests.

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I have a history of serious heart problems.

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My family has a history of sudden heart-related deaths or irregular heartbeats.

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I drink more than the specified weekly alcohol limit.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Trial 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

0 / 11Eligibility criteria met

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

Common treatments for ADHD include stimulant medications like methylphenidate and amphetamines, which increase dopamine and norepinephrine levels by inhibiting their reuptake and promoting their release. Non-stimulant medications, such as atomoxetine, selectively inhibit the reuptake of norepinephrine. These treatments target neurotransmitter pathways that are often dysregulated in ADHD, helping to improve attention, focus, and impulse control. Understanding these mechanisms is important for patients as it guides treatment choices and helps manage expectations regarding efficacy and side effects.

Management of ADHD in adults.