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

NCT02141113 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-08-12

Study results available
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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.

Conditions

  • Adult Attention-Deficit Hyperactivity Disorder

Interventions

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

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • Rochester Center for Behavioral Medicine

    lead OTHER

Principal Investigators

  • Joel L Young, MD · Rochester Center for Behavioral Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-09-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02141113 on ClinicalTrials.gov