Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65). (ADINT2012)

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

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.

Study Overview

• Status: Completed
• Conditions: Adult Attention-Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Guanfacine Hydrocholride

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Center for Behavioral Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Guanfacine Hydrocholride; mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD)	Drug: Guanfacine Hydrocholride; mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); Other Names: Intuniv
Placebo Comparator: Sugar Pill Guanfacine Hydrocholride; mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD); mg Guanfacine Hydrochloride (orally, QD)	Drug: Guanfacine Hydrocholride; mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); mg Guanfacine Hydrochloride (orally); Other Names: Intuniv

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and efficacy of GH as adjunctive medication to psychostimulants in adult ADHD	Will be evaluated using three primary measures; 1: ADHD rating scale with adult prompts (ADHD-RS), 2:Clinical Global Impression-Improvement (CGI-I, and 3: Clinical Global Impression-Severity (CGI-S).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess safety and tolerability of GH.	Aside from exploring general safety and tolerability of GH, the study will also investigate the safety and tolerability of 5mg and 6mg doses of GH and the safety and tolerability of down titration of GH at the end of the study. Safety of GH will be assessed throughout the course of the study through the collection of a series of vitals, including: blood pressure, weight, pulse rate, and physical examination. Medication tolerability will be assessed by surveying levels of fatigue (Fatigue Symptoms Inventory), sleep quality (Pittsburgh Sleep Quality Index (PSQI)), anxiety (Hamilton Anxiety Rating Scale (HAM-A)), mood (Hamilton Depression Rating Scale (HAM-D)), and sexual functioning (Arizona Sexual Experience Scale (ASEX)) throughout the course of the study.	Pre-treatment, during treatment, end of study (8 weeks)

Collaborators and Investigators

• Sponsor: Rochester Center for Behavioral Medicine
• Collaborators: Shire
• Investigators: Principal Investigator: Joel L Young, MD, Rochester Center for Behavioral Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: November 20, 2013
• First Submitted That Met QC Criteria: May 14, 2014
• First Posted (Estimate): May 19, 2014

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Guanfacine
• Other Study ID Numbers: 1129704 ADINT