The purpose of this research study is to evaluate the effect of atomoxetine (also known as Strattera) compared to placebo (inactive substance) on daily activities such as attention and focus, thinking ability and muscle movements in subjects with early HD and attention deficit disorder...
Date First Received: August 24, 2006
Last Updated: December 19, 2007
Verified by: University of Iowa, December 2007
Clinical Trial Phase: Phase 2 | Start Date: November 2005
Overall Status: Active, not recruiting
Estimated Enrollment: 20
Brief Summary
Official Title: “Atomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover Study”
Condition Keyword(s):
Intervention(s):
The purpose of this research study is to evaluate the effect of atomoxetine (also known as Strattera) compared to placebo (inactive substance) on daily activities such as attention and focus, thinking ability and muscle movements in subjects with early HD and attention deficit disorder.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Study Primary Completion Date: March 2008
Detailed Clinical Trial Description
No medications have been investigated to improve attention and executive functions in patients with Huntington's disease, despite the evidence that these cognitive domains can be abnormal even before motor symptom onset. Because cognitive symptoms are highly associated with functional disability, treatments aimed at improving cognitive functions would be of significant benefit to patients in the early stages of the disease. Atomoxetine is the ideal choice for such a trial. It has proven efficacy in adults with ADHD and it selectively targets norepinephrine and dopamine in the prefrontal cortex rather than in subcortical areas. This selectivity is an advantage for patients with HD, because motor side effects are less likely to be facilitated than with a psychostimulant. The present study is a feasibility study in which we propose to administer either 80 mg atomoxetine for 4 weeks or placebo to 20 patients with early HD and who also complain of mild cognitive symptoms. The groups will then crossover to the other condition (atomoxetine or placebo). Participants will be assessed on measures of ADHD symptoms and a sensitive battery of neuropsychological tests. Based on the shared neural circuitry in ADHD and HD, and the demonstrated effectiveness of atomoxetine on attention in adults with ADHD, improved performance on cognitive tests of attention and executive functions and on subjects' report of ADHD symptoms are expected in the atomoxetine treatment phase. No changes in motor status are predicted during the study.
Intervention(s) in this Clinical Trial
- Drug: atomoxetine
- This study utilizes a crossover design. Participants receive 40mg bid atomoxetine or placebo at arm 01 and arm 02 using a 1:1 allocation
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Placebo or 40mg bid atomoxetine, using a 1:1 allocation
- Experimental: 2
- 40mg bid atomoxetine or placebo, using a 1:1 allocation
Outcome Measures for this Clinical Trial
Primary Measures
- Primary dependent variables will be CAARS score and a cognitive summary score.
- Time Frame: Not available
Safety Issue?: No
- Time Frame: Not available
Secondary Measures
- Secondary measures include individual cognitive tests, UHDRS motor score and SCL-90-R global index score.
- Time Frame: Not available
Safety Issue?: No
- Time Frame: Not available
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Confirmed Huntington's disease diagnosis
- Age 18-65
- Must have mild HD
- Must have complaints of poor attention
Exclusion Criteria:
- Childhood history of ADHD symptoms
- Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe anxiety
- Current use of an MAOI
- Pregnancy
- Uncontrolled hypertension
- Tachycardia
- Cardiovascular or cerebrovascular disease
- History of a loss of consciousness for greater than (or equal to) 5 minutes
- Having any neurological disorder or insult other than Huntington disease
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 65 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Iowa
Overall Clinical Trial Officials and Contacts
Leigh J Beglinger, Ph.D. Principal Investigator The University of Iowa
Related Publications
References
[No authors listed] A novel gene containing a trinucleotide repeat that is expanded and unstable on Huntington's disease chromosomes. The Huntington's Disease Collaborative Research Group. Cell. 1993 Mar 26;72(6):971-83.
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Beglinger, L. et al. The association between speed of processing and cerebral white matter volume in patients with mild Huntington's disease [abstract]. Poster session accepted at the Annual Meeting of the Cognitive Neuroscience Society, April, 2004
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Spencer T, Biederman J, Wilens T, Prince J, Hatch M, Jones J, Harding M, Faraone SV, Seidman L. Effectiveness and tolerability of tomoxetine in adults with attention deficit hyperactivity disorder. Am J Psychiatry. 1998 May;155(5):693-5.
Michelson D, Adler L, Spencer T, Reimherr FW, West SA, Allen AJ, Kelsey D, Wernicke J, Dietrich A, Milton D. Atomoxetine in adults with ADHD: two randomized, placebo-controlled studies. Biol Psychiatry. 2003 Jan 15;53(2):112-20.
Conners, CK et al. Conners' Adult ADHD Rating Scales (CAARS). 1999. North Tonawanda, NY: Multi-Health Systems.
Additional Information
Information obtained from ClinicalTrials.gov on November 19, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368849
Study ID Number: 200508775
ClinicalTrials.gov Identifier: NCT00368849
Health Authority: United States: Institutional Review Board
University of Iowa Huntington's Disease Center of Excellence
Clinical Trials Authorship and Review
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