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

Insomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01156051
• Other study ID #: CSHTR-TR-0901
• Status: Terminated
• Phase: Phase 4
• First received: July 1, 2010
• Last updated: July 21, 2014
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: July 2014
• Source: Children's Specialized Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01153178

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Attention-Deficit/Hyperactivity Disorder
• Disease
• Hyperkinesis
• Insomnia
• Parasomnias
• Sleep Disorders

Intervention

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
• Placebo comparator
Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).

Locations

Country	Name	City	State
United States	Children's Specialized Hospital	Hamilton	New Jersey
United States	Children's Specialized Hospital	Toms River	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Children's Specialized Hospital	Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Polysomnographic Total Sleep Time (TST)	Change in objective measures of sleep, using polysomnography	Baseline to last observation carried forward (after at least one week of dose stability)	No
Secondary	Change in Baseline to Treatment ADHD-Rating Scale IV Total Score	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).	Baseline to last observation carried forward (after at least one week of dose stability)	No
Secondary	Change in Baseline to Treatment Latency to Persistent Sleep (LPS)	Change in an objective measure of sleep onset, using polysomnography.	Baseline to last observation carried forward (after at least one week of dose stability)	No
Secondary	Change in Baseline to Treatment Minutes of Wake Time After Sleep Onset (WASO)	Polysomnographic parameter of sleep assessing how many minutes of wakefulness occurred after sleep onset and before full morning awakening.	Baseline to last observation carried forward (after at least one week of dose stability)	No