Clinical trial NCT02141113: Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65).
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Adult Attention-Deficit Hyperactivity Disorder
Lead sponsor: Rochester Center for Behavioral Medicine
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2014-05-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion:

* 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:

* 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.

Primary outcomes:
measure: Safety and efficacy of GH as adjunctive medication to psychostimulants in adult ADHD
timeFrame: 8 weeks
Secondary outcomes:
measure: Assess safety and tolerability of GH.
timeFrame: Pre-treatment, during treatment, end of study (8 weeks)
Other outcomes:
Locations:
city: Rochester Hills
country: United States
facility: Rochester Center for Behavioral Medicine
state: Michigan
Study officials:
affiliation: Rochester Center for Behavioral Medicine
name: Joel L Young, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.