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

NCT02141113 | Completed Phase 4 Results

• 1 other identifier: 1129704 ADINT
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Attention-Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• ADHD-RS Change From Baseline to Endpoint

  The ADHD-RS is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared the mean change in ADHD-RS total score from baseline to endpoint of the study.

  0 weeks, 8 weeks

Secondary Outcomes (2)

• The Clinical Global Impression (Severity)

  0 weeks, 8 weeks

• The Clinical Global Impression- Improvement (CGI-I)

  8 weeks

Other Outcomes (5)

• Fatigue Symptoms Inventory (FSI) Change From Baseline to Endpoint

  0 weeks, 8 weeks

• Hamilton Anxiety Inventory Change From Baseline to Endpoint

  0 weeks, 8 weeks

• Arizona Sexual Experiences Scale (ASEX) Change From Baseline to Endpoint

  0 weeks, 8 weeks

Study Arms (2)

Guanfacine Hydrochloride

ACTIVE COMPARATOR

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)

Drug: Guanfacine Hydrochloride

Sugar Pill

PLACEBO COMPARATOR

1. mg Placebo 2. mg Placebo 3. mg Placebo 4. mg Placebo 5. mg Placebo 6. mg Placebo

Other: Placebo

Interventions

Guanfacine Hydrochloride 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)

Also known as: Intuniv

Guanfacine Hydrochloride

Placebo OTHER

Placebo of matching mg

Sugar Pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rochester Center for Behavioral Medicine: lead
• Shire: collaborator

Study Sites (1)

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

Related Publications (1)

• 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.

  PMID: 26730446 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Guanfacine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

Relatively small sample size and herterogenous sample (male paticipants = 14 and female participants = 12).

Results Point of Contact

• Title: Joel L. Young, MD
• Organization: Rochester Center for Behavioral Medicine

jyoung@rcbm.net

2486088800

Study Officials

• Joel L Young, MD

  Rochester Center for Behavioral Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2013
• First Posted: May 19, 2014
• Study Start: November 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 12, 2025
• Results First Posted: August 12, 2025

Record last verified: 2025-07

Locations

US (1)