Clinical trial NCT00368849: Atomoxetine and Huntington's Disease
Official title: Atomoxetine for Attention Deficits in Adults With Mild HD: A Randomized, Placebo-Controlled Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Huntington Disease
Chorea
Keywords: Huntington Disease
Chorea
Attention
ADHD
ADD
Strattera
Atomoxetine
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2006-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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 Huntington Disease (HD) and attention deficit disorder (ADD).

Detailed 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 attention deficit hyperactivity disorder (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 milligram (mg) atomoxetine for 4 weeks or placebo to 20 patients with early HD 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.

Eligibility criteria: Inclusion Criteria:

* Confirmed Huntington's disease (HD) diagnosis
* Age 18 to 65
* Must have mild HD
* Must have complaints of poor attention

Exclusion Criteria:

* Childhood history of attention deficit hyperactivity disorder (ADHD) symptoms
* Diagnosis of schizophrenia, bipolar affective disorder, dementia, delirium or severe anxiety
* Current use of a monoamine oxidase inhibitor (MAOI) medication
* 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

Primary outcomes:
measure: Conners' Adult Attention Rating Scale (CAARS)
timeFrame: There are two time points for this measure: baseline and after 4 weeks of treatment
measure: Attention Composite Score
timeFrame: There are two time points for this measure: baseline and after 4 weeks of treatment
measure: Executive Composite Score
timeFrame: There are two time points for this measure: baseline and after 4 weeks of treatment
Secondary outcomes:
measure: Symptom Checklist-90-Revised (SCL-90-R)
timeFrame: There are two time points for this measure: baseline and after 4 weeks of treatment
measure: Unified Huntington Disease Rating Scale (UHDRS) Total Motor Score
timeFrame: There are two time points for this measure: baseline and after 4 weeks of treatment
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Leigh J Beglinger, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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