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

Phase 4

Terminated

• Conditions: Attention Deficit Disorder; Attention-Deficit/Hyperactivity Disorder; Sleep Disorders; Insomnia
• Interventions: Drug: Placebo comparator; Drug: Guanfacine extended-release tablets

• Registration Number: NCT01156051
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-01
• Study First Submitted QC: 2010-07-01
• Study First Posted: 2010-07-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Results First Submitted: 2014-05-31
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-21
• Last Update Submitted: 2014-07-21
• Results First Posted: 2014-08-11
• Last Update Posted: 2014-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo comparator	Placebo comparator	Placebo control
Guanfacine Extended-Release Tablets	Guanfacine extended-release tablets	Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg

Primary Outcome Measures

Name	Time	Method
Change in Polysomnographic Total Sleep Time (TST)	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

Name	Time	Method
Change in Baseline to Treatment ADHD-Rating Scale IV Total Score	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).
Change in Baseline to Treatment Latency to Persistent Sleep (LPS)	Baseline to last observation carried forward (after at least one week of dose stability)	Change in an objective measure of sleep onset, using polysomnography.
Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)	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.

Trial Locations

Locations (1)

Children's Specialized Hospital; 🇺🇸 Toms River, New Jersey, United States