NCT02141113

Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65).

Double-Blind, Randomized, Placebo-Controlled, Single- Center, Dose Optimization Study Evaluating Efficacy and Safety of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults Aged 18-65 Years With a Diagnosis of ADHD

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Rochester Center for Behavioral Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is considered an investigator-initiated clinical research trial, which means that your study doctor is researching a particular medication (in this case a medication that is currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication is guanfacine hydrochloride. The hypothesis is that this medication could be used in adults with Attention Deficit/Hyperactivity Disorder who have not received satisfactory results with their current stimulant ADHD medication. The study drug is investigational for use in adults. Investigational means it has not been approved by the U.S. Food and Drug Administration (FDA) for use in adults.

Detailed description

The purpose of this study is to determine whether guanfacine hydrochloride used as an adjunct therapy (to subjects' current stimulant medication) would bring about a statistically significant improvement in AD/HD symptoms.

Conditions

• Adult Attention-Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	Guanfacine Hydrochloride	1. mg Guanfacine Hydrochloride (orally) 2. mg Guanfacine Hydrochloride (orally) 3. mg Guanfacine Hydrochloride (orally) 4. mg Guanfacine Hydrochloride (orally) 5. mg Guanfacine Hydrochloride (orally) 6. mg Guanfacine Hydrochloride (orally)
OTHER	Placebo	Placebo of matching mg

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-09-01
• Completion: 2014-11-01
• First posted: 2014-05-19
• Last updated: 2025-08-12
• Results posted: 2025-08-12

Locations

1 site across 1 country: United States