Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)
Public ClinicalTrials.gov record NCT01124708. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-blind, Randomized, Placebo-controlled, Multicenter, Fixed Dose Titration Study to Assess Efficacy, Safety, and Tolerability of TC-5619 in Adults With Attention Deficit/Hyperactivity Disorder (ADHD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
ADHD has been associated with persistent deficits in the efficient allocation of attention and supports the notion that regulation of the cholinergic system may improve these cognitive deficits in ADHD. It has been suggested that the effects of nicotine are most pronounced on tasks that demand effortful processing (Rusted and Warburton 1994). In addition, a recent theory proposes that the cholinergic system allocates additional attentional resources during tasks that are demanding (i.e. sustained attention, set shifting, etc; Sarter and Bruno 1997). Thus it may be that in ADHD, cholinergic systems are under-responsive or under-developed and thus stimulation of nicotinic receptors via nicotinic agents may result in improved cognitive performance particularly on tests requiring effortful processing.
Study identification
- NCT ID
- NCT01124708
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 134 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2010 (Type not available)
- Primary completion
- Feb 2011 (Actual)
- Completion
- Feb 2011 (Actual)
- Last update posted
- Sep 13, 2013
2010 – 2011
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Florida Clinical Research Center, LLC | Bradenton | Florida | 34208 | — |
| Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida | 32216 | — |
| Fidelity Clinical Research, Inc | Lauderhill | Florida | 33319 | — |
| Florida Clinical Research Center, LLC | Maitland | Florida | 32751 | — |
| Scientifc Clinical Research, Inc. | North Miami | Florida | 33161 | — |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | — |
| Atlanta Center For Clinical Research | Atlanta | Georgia | 30308 | — |
| CRI Worldwide, LLC (Lourdes Division) | Willingboro | New Jersey | 08046 | — |
| Neuro-Behavioral Clinical Research, Inc. | Canton | Ohio | 44718 | — |
| Midwest Clinical Research Center | Dayton | Ohio | 45417 | — |
| Oregon Center For Clinical Investigations, Inc. (OBBI, Inc.) | Portland | Oregon | 97210 | — |
| CRI Worldwide, LLC (Kirkbride Division) | Philadelphia | Pennsylvania | 19139 | — |
| Clinical Neuroscience Solutions, Inc. | Memphis | Tennessee | 38119 | — |
| FutureSearch Clinical Trials, LP | Austin | Texas | 78756 | — |
| Claghorn-Lessem Research Clinic | Houston | Texas | 77008 | — |
| Fletch Allen Health Care, Dept. of Psychiatry, Univ. of Vermont | Burlington | Vermont | 05401 | — |
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 NCT01124708, 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 Sep 13, 2013 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01124708 live on ClinicalTrials.gov.