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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02141113
Recruitment Status : Completed
First Posted : May 19, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Rochester Center for Behavioral Medicine

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.


Condition or disease Intervention/treatment Phase
Adult Attention-Deficit Hyperactivity Disorder Drug: Guanfacine Hydrocholride Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : November 2014


Arm Intervention/treatment
Active Comparator: Guanfacine Hydrocholride
  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 Hydrocholride
  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)
Other Name: Intuniv

Placebo Comparator: Sugar Pill Guanfacine Hydrocholride
  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 Hydrocholride
  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)
Other Name: Intuniv




Primary Outcome Measures :
  1. Safety and efficacy of GH as adjunctive medication to psychostimulants in adult ADHD [ Time Frame: 8 weeks ]
    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 :
  1. Assess safety and tolerability of GH. [ Time Frame: Pre-treatment, during treatment, end of study (8 weeks) ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141113


Locations
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United States, Michigan
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, United States, 48307
Sponsors and Collaborators
Rochester Center for Behavioral Medicine
Shire
Investigators
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Principal Investigator: Joel L Young, MD Rochester Center for Behavioral Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rochester Center for Behavioral Medicine
ClinicalTrials.gov Identifier: NCT02141113    
Other Study ID Numbers: 1129704 ADINT
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Guanfacine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs