Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Public ClinicalTrials.gov record NCT02604407. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 3, Randomized, Double-blind, Multicenter, Placebo-controlled, Forced-dose Titration, Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.
Study identification
- NCT ID
- NCT02604407
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 275 participants
Conditions and interventions
Interventions
- SHP465 12.5mg capsules (one capsule daily) Drug
- Placebo Other
- SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily) Drug
Drug · Other
Eligibility (public fields only)
- Age range
- 18 Years to 55 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 19, 2015 (Actual)
- Primary completion
- Mar 24, 2016 (Actual)
- Completion
- Mar 24, 2016 (Actual)
- Last update posted
- Jun 3, 2021
2015 – 2016
United States locations
- U.S. sites
- 45
- U.S. states
- 23
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pharmacology Research Institute | Encino | California | 91316 | — |
| Pharmacology Research Institute (Pri) | Los Alamitos | California | 90720 | — |
| Pharmacology Research Institute (Pri) | Newport Beach | California | 92660 | — |
| Nrc Research Institute | Orange | California | 92868 | — |
| Elite Clinical Trials | Wildomar | California | 92595 | — |
| McB Clinical Research | Colorado Springs | Colorado | 80910 | — |
| Florida Clinical Research Center Llc | Bradenton | Florida | 32401 | — |
| Gulfcoast Clinical Research Center | Fort Myers | Florida | 33912 | — |
| Sarkis Clinical Trials | Gainesville | Florida | 32607 | — |
| Clinical Neuroscience Solutions, Inc | Jacksonville | Florida | 32256 | — |
| Florida Clinical Research Center, Llc | Maitland | Florida | 32751 | — |
| Qps Mra, Llc | Miami | Florida | 33143 | — |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | — |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | — |
| Northwest Behavioral Research Center | Marietta | Georgia | 30060 | — |
| Capstone Clinical | Libertyville | Illinois | 60048 | — |
| Baber Research Group, Inc | Naperville | Illinois | 60563 | — |
| Psychiatric Associates | Overland Park | Kansas | 66211 | — |
| Louisiana Research Associates, Inc. | New Orleans | Louisiana | 70114 | — |
| Rochester Center For Behavioral Medicine | Rochester Hills | Michigan | 48307 | — |
| Clinical Neurophysiology Services | Sterling Heights | Michigan | 48314 | — |
| Psychiatric Care and Research Center | O'Fallon | Missouri | 63368 | — |
| Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Premier Psychiatric Research Institutute | Lincoln | Nebraska | 68526 | — |
| Center For Psychiatry and Behavioral Medicine, Inc | Las Vegas | Nevada | 89128 | — |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| Bioscience Research Llc | Mount Kisco | New York | 10549 | — |
| Nyu Langone Medical Center | New York | New York | 10016 | — |
| Richard H Weisler, Md, Pa & Associates | Raleigh | North Carolina | 27609 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Ips Research Company | Oklahoma City | Oklahoma | 73103 | — |
| Oregon Center For Clinical Investigations, Inc | Portland | Oregon | 97214 | — |
| Oregon Center For Clinical Investigations | Salem | Oregon | 97301 | — |
| Omega Medical Research | Warwick | Rhode Island | 02886 | — |
| Rainbow Research, Inc. | Barnwell | South Carolina | 29812 | — |
| Coastal Carolina Research | Mt. Pleasant | South Carolina | 29464 | — |
| Clinical Neuroscience Solutions | Memphis | Tennessee | 38119 | — |
| Futuresearch Trials of Dallas, Lp | Dallas | Texas | 75231 | — |
| Bayou City Research, Ltd | Houston | Texas | 77007 | — |
| Red Oak Psychiatry Associates | Houston | Texas | 77090 | — |
| Houston Clinical Trials, Llc | Houston | Texas | 77098 | — |
| Research Across America | Plano | Texas | 75093 | — |
| Neuroscience, Inc | Herndon | Virginia | 20170 | — |
| Eastside Therapeutic Resource | Kirkland | Washington | 98033 | — |
| Summit Research Network (Seattle) Llc | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02604407, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 3, 2021 · Synced Nov 6, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02604407 live on ClinicalTrials.gov.