CIT-HD: Study in Huntington's Disease



Status:Archived
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:7/1/2011

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A Randomized, Placebo-Controlled Pilot Study in Huntington's Disease (CIT-HD)


This research plan proposes to conduct a double-blind, placebo-controlled pilot clinical
trial in 36 adults with mild Huntington's disease (HD) to address the following research
aims:

1. To determine the effect of citalopram compared to placebo in patients with early HD on
executive function and other outcome variables including functional measures
(health-related quality of life, work productivity, and self-reported attention), motor
performance, and psychiatric status,

2. To study the relationship between executive function and functional status in patients
with early HD after selective serotonin reuptake inhibitor (SSRI) treatment, and

3. To examine the effect of citalopram treatment on volumetric and metabolic (i.e,
N-acetyl-aspartate concentration) measures in the neostriatum among patients with
recently diagnosed Huntington's disease.


Specific Aims:

1. To examine the effects of sixteen weeks of treatment with the selective serotonin
reuptake inhibitor (SSRI) citalopram compared to placebo on executive function in
patients with early Huntington's disease (HD).

2. To study the relationship between executive function and functional status in patients
with early HD after SSRI treatment.

3. To determine the effect of sixteen weeks of citalopram compared to placebo on other
outcome variables including functional measures (health-related quality of life, work
productivity, and self-reported attention), motor performance, and psychiatric status.

4. To examine the effect of citalopram treatment on volumetric and metabolic (i.e,
N-Acetyl-Aspartate concentration) measures in the neostriatum among patients with
recently diagnosed Huntington's Disease.

Main Hypotheses:

1. At the end of the treatment protocol (i.e., sixteen weeks), patients receiving
citalopram as compared with placebo will show a significantly greater improvement on
tests of executive function.

2. Performance on measures of executive function will be significantly associated with
measures of functional status.

3. At the end of the treatment protocol (i.e., sixteen weeks), patients receiving
citalopram as compared with placebo will show a significantly greater improvement in
functional status and psychiatric ratings; motor score is not expected to change as a
result of citalopram therapy.

4. Using structural MRI and 1H-MRS, after 16 weeks of citalopram treatment, patients with
recently diagnosed Huntington's Disease will show greater changes from baseline on
volumetric and metabolic (i.e., N-Acetyl-Aspartate concentration) neuroimaging measures
in the neostriatum than those on placebo.


We found this trial at
3
sites
5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
Mayo Clinic Scottsdale Mayo Clinic Arizona was the second Mayo practice to be established outside...
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Scottsdale, AZ
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
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Iowa City, IA
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601 Elmwood Ave
Rochester, New York 14642
(585) 275-2100
Strong Memorial Hospital (University of Rochester School of Medicine) In addition to offering traditional and...
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from
Rochester, NY
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