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

Primary Purpose

Adult Attention-Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Guanfacine Hydrocholride
Guanfacine Hydrocholride
Sponsored by
Rochester Center for Behavioral Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Attention-Deficit Hyperactivity Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rochester Center for Behavioral Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Guanfacine Hydrocholride

Sugar Pill Guanfacine Hydrocholride

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
November 20, 2013
Last Updated
December 2, 2014
Sponsor
Rochester Center for Behavioral Medicine
Collaborators
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT02141113
Brief Title
Efficacy and Safety Eval of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults (18-65).
Acronym
ADINT2012
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rochester Center for Behavioral Medicine
Collaborators
Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Attention-Deficit Hyperactivity Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Guanfacine Hydrocholride
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Sugar Pill Guanfacine Hydrocholride
Arm Type
Placebo Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Guanfacine Hydrocholride
Other Intervention Name(s)
Intuniv
Intervention Description
mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally)
Intervention Type
Drug
Intervention Name(s)
Guanfacine Hydrocholride
Other Intervention Name(s)
Intuniv
Intervention Description
mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally) mg Guanfacine Hydrochloride (orally)
Primary Outcome Measure Information:
Title
Safety and efficacy of GH as adjunctive medication to psychostimulants in adult ADHD
Description
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).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Assess safety and tolerability of GH.
Description
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.
Time Frame
Pre-treatment, during treatment, end of study (8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel L Young, MD
Organizational Affiliation
Rochester Center for Behavioral Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rochester Center for Behavioral Medicine
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26730446
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.
Results Reference
derived

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

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