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

NCT ID: NCT02141113

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2014-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Guanfacine Hydrochloride

1. mg Guanfacine Hydrochloride (orally, QD)

2. mg Guanfacine Hydrochloride (orally, QD)

3. mg Guanfacine Hydrochloride (orally, QD)

4. mg Guanfacine Hydrochloride (orally, QD)

5. mg Guanfacine Hydrochloride (orally, QD)

6. mg Guanfacine Hydrochloride (orally, QD)

Group Type: ACTIVE_COMPARATOR

Guanfacine Hydrochloride

Intervention Type: DRUG

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)

Sugar Pill

1. mg Placebo

2. mg Placebo

3. mg Placebo

4. mg Placebo

5. mg Placebo

6. mg Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo of matching mg

Interventions

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)

Intervention Type: DRUG

Placebo

Placebo of matching mg

Intervention Type: OTHER

Other Intervention Names

Intuniv

Eligibility Criteria

Inclusion Criteria

• Male and females (non pregnant) ages 18-65
• Current diagnosis of ADHD and have met the DSM-IV-TR criteria for ADHD
• Currently taking an adequate dose stimulant to treat their ADHD (with a sub-optimal response). A suboptimal response is determined by a baseline score of 28 or greater on the ADHD-RS or a CGI score of 4 or greater.
• Subjects must be of normal intelligence
• English speaking
• Able to swallow pills.

Exclusion Criteria

• Non pregnant or lactating females
• Severe Axis I and Axis II disorders
• Suicidal
• Tourette's
• Heart disease or any other serious chronic or acute unstable medical conditions/illnesses that would compromise participation or likely lead to hospitalization during the duration of the study.
• A known history or presence of cardiovascular, hepatic, renal, respiratory, or hematologic abnormalities, narrow angle glaucoma, or any other unstable medical or psychiatric conditions (as judged by the primary investigator)
• A current or recent history (within the past 6 months) of suspected substance abuse and/or drug dependence as defined by DSM-IV-TR criteria
• Healthy weight (not under or over as judged by investigator)
• No immediate family member of the investigator or research staff No involvement in a research study in the last 30 days.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: collaborator

Rochester Center for Behavioral Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joel L Young, MD

Role: PRINCIPAL_INVESTIGATOR

Rochester Center for Behavioral Medicine

Locations

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, United States

Countries

United States

References

Butterfield ME, Saal J, Young B, Young JL. Supplementary guanfacine hydrochloride as a treatment of attention deficit hyperactivity disorder in adults: A double blind, placebo-controlled study. Psychiatry Res. 2016 Feb 28;236:136-141. doi: 10.1016/j.psychres.2015.12.017. Epub 2015 Dec 17.

Reference Type: DERIVED

PMID: 26730446 (View on PubMed)

Other Identifiers

1129704 ADINT

Identifier Type: -

Identifier Source: org_study_id