Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia

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. Identifier: NCT01156051
Recruitment Status : Terminated (extended beyond completion date; chose to close out rather than renew IRB review)
First Posted : July 2, 2010
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Information provided by (Responsible Party):
Thomas Rugino, Children's Specialized Hospital

Brief Summary:
This study seeks to determine, using special sleep tests (polysomnography and actigraphy) if guanfacine extended release is able to improve nighttime sleep in children with ADHD - associated insomnia while improving daytime ADHD symptoms. Male and female children with diagnosed or suspected ADHD with sleep problems (difficulty falling asleep, difficulty staying asleep, or less than expected hours of sleep) will be recruited. After obtaining informed consent and assent (when appropriate) and after discontinuation of excluded medications, children will have evaluations of his or her sleep and evaluations confirming the ADHD diagnosis. Children who successfully pass screening will be enrolled into the double-blind, placebo-controlled, randomized investigation with 50% of participants receiving guanfacine extended release and 50% of participants receiving matching placebo. Using a flexible-dose optimization design based on ADHD symptom improvement and medication tolerability, the dose will be adjusted between 1 to 4 mg over the course of four weeks. At the end of medication adjustment (week 4 or 5), ADHD questionnaires, sleep questionnaires, and sleep tests will be repeated and analyzed. The medication will be weaned over the course of the following 3-10 days.

Condition or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder Attention Deficit Disorder Insomnia Sleep Disorders Drug: Guanfacine extended-release tablets Drug: Placebo comparator Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Guanfacine Extended-Release on Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia
Study Start Date : June 2010
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Guanfacine Extended-Release Tablets
Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg
Drug: Guanfacine extended-release tablets
Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated
Other Name: Intuniv (TM), guanfacine HCl, SPD503

Placebo Comparator: Placebo comparator
Placebo control
Drug: Placebo comparator
Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).
Other Name: "sugar pill"

Primary Outcome Measures :
  1. Change in Polysomnographic Total Sleep Time (TST) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]
    Change in objective measures of sleep, using polysomnography

Secondary Outcome Measures :
  1. Change in Baseline to Treatment ADHD-Rating Scale IV Total Score [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]
    Change in baseline to treatment ADHD-Rating Scale IV (Investigator-interview ) total. This scale quantitates ADHD symptoms based on DSM-IV criteria with a minimum score of 0 and a maximum score of 54 (higher scores suggesting more ADHD symptoms). The total score is a sum of the 9 items on the ADHD Rating Scale IV inattention score and the 9 items on the ADHD Rating Scale IV hyperactivity-impulsivity score (scores for each 0-27).

  2. Change in Baseline to Treatment Latency to Persistent Sleep (LPS) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]
    Change in an objective measure of sleep onset, using polysomnography.

  3. Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO) [ Time Frame: Baseline to last observation carried forward (after at least one week of dose stability) ]
    Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject must be male or female, aged 6 - 12 years with ADHD.
  2. Subject must (a) be taking methylphenidate, amphetamine, or atomoxetine for treatment of ADHD with parent or subject concerns of inadequate efficacy or intolerable side effects, or (b) free of any other medication used to treat ADHD for at least 30 days at the time of the initial sleep study.
  3. Subject must have repeated difficulty with sleep initiation or persistence despite attempts at adequate sleep hygiene.
  4. Subject must be able to swallow tablets.

Exclusion Criteria:

  1. Subject or parent/LAR is unable or unwilling to discontinue present medications used to treat ADHD.
  2. Subject has a body mass index < 5th percentile for age, using the Centers for Disease Control standards reported in 2000.
  3. Subject has a body weight > 176 pounds.
  4. Subject has a diagnosis of Autism or Autism Spectrum Disorder.
  5. Subject has other serious psychiatric diagnoses.
  6. Subject has a medical condition that may require treatment with an unapproved medication, that may cause a safety concern, or that may confound outcome results
  7. Subject has an excessive caffeine intake (greater than 2.5 mg/kg/d).
  8. Subject has a prior problem with clonidine or guanfacine.

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 identifier (NCT number): NCT01156051

United States, New Jersey
Children's Specialized Hospital
Hamilton, New Jersey, United States, 08619
Children's Specialized Hospital
Toms River, New Jersey, United States, 08755
Sponsors and Collaborators
Children's Specialized Hospital
Principal Investigator: Thomas A Rugino, MD Children's Specialized Hospital

Responsible Party: Thomas Rugino, Principal Investigator, Children's Specialized Hospital Identifier: NCT01156051     History of Changes
Obsolete Identifiers: NCT01153178
Other Study ID Numbers: CSHTR-TR-0901
First Posted: July 2, 2010    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014
Last Verified: July 2014

Keywords provided by Thomas Rugino, Children's Specialized Hospital:
sleep disturbance

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Attention Deficit Disorder with Hyperactivity
Sleep Wake Disorders
Pathologic Processes
Sleep Disorders, Intrinsic
Nervous System Diseases
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Neurologic Manifestations
Signs and Symptoms
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