Evaluating a new combination therapy for ADHD in adolescents
A Phase 2 Randomized Double-Blind, Parallel, Adaptive-Design, Clinical Trial to Evaluate the Safety and Efficacy of NRCT-101SR With NRCT-202XR Compared to NRCT-202XR Alone in Subjects With Attention-Deficit/Hyperactivity Disorder
This study is testing a new combination therapy for ADHD in teenagers to see if it works better than a placebo or a single medication.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | Neurocentria, Inc. Industry-sponsored |
| Locations | 5 sites (Maitland, Florida and 4 other locations) |
| Trial ID | NCT06673368 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to assess the safety and efficacy of a combination therapy involving NRCT-101SR and NRCT-202XR in adolescents diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD). The study will be conducted over a 6-week period and will involve approximately 60 participants aged 13-17 years. It employs a randomized, double-blind, parallel, adaptive design, with subjects being assigned to different treatment arms to compare the effects of the combination therapy against a placebo and a single medication. The trial aims to gather data on the therapeutic benefits and side effects of the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 13-17 years who have a confirmed diagnosis of ADHD and are currently taking ADHD medication.
Not a fit: Patients who do not have a diagnosis of ADHD or are not currently on ADHD medication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for adolescents with ADHD, potentially improving their symptoms and overall quality of life.
How similar studies have performed: Other studies have shown promise in combination therapies for ADHD, suggesting that this approach may yield beneficial results.
Eligibility criteria
Show full inclusion / exclusion criteria
1. Male or female, 13-17 years of age at screening. 2. Has a prior primary diagnosis of ADHD according to the DSM-5 classification evident by a medical record and confirmed with MINI using DSM-5 probes. 3. Is taking ADHD medication 4-7 days/week, for at least 4 weeks at Screening and at least 6 weeks at Baseline. 4. Has side effects identified using SDSE-RS at Screening and Baseline. 5. CGI-S ≥ X (blinded) at Screening and Baseline. 6. Must be fluent in English and communicate effectively with others. 7. Both subject and parent/guardian willing and able to give informed assent/consent. 8. Parent/guardian willing to serve as informant.
Where this trial is running
Maitland, Florida and 4 other locations
- Accel Research Site-Maitland Clinical Research Unit — Maitland, Florida, United States (Recruiting)
- iResearch Atlanta — Decatur, Georgia, United States (Recruiting)
- CenExel iRS - iResearch Savannah — Savannah, Georgia, United States (Recruiting)
- Boston Clinical Trials LLC — Boston, Massachusetts, United States (Recruiting)
- Center For Psychiatry and Behavioral Medicine — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: Mia Taylor, BS
- Email: info@neurocentria.com
- Phone: (925) 954-4868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.