CIT-HD: Study in Huntington's Disease
This study is currently recruiting participants.
Verified by University of Iowa, January 2009
First Received: December 30, 2005 Last Updated: June 22, 2009
Sponsors and Collaborators:
University of Iowa
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00271596
Purpose
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:
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,
To study the relationship between executive function and functional status in patients with early HD after selective serotonin reuptake inhibitor (SSRI) treatment, and
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.
Phase
Huntington DiseaseChorea AttentionExecutive Dysfunction
Drug: 20mg qd citalopram or placebo
Phase II
Study Type:
Interventional
Study Design:
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:
A Randomized, Placebo-Controlled Pilot Study in Huntington's Disease (CIT-HD)
Further study details as provided by University of Iowa:
Primary Outcome Measures:
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 [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
volumetric and metabolic (i.e., N-Acetyl-Aspartate concentration) neuroimaging measures in the neostriatum [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
serotonin transporter gene polymorphism (5HTTLPR) and cognitive treatment response to an SSRI [ Time Frame: after 16 weeks of treatment ] [ Designated as safety issue: No ]
Estimated Enrollment:
36
Study Start Date:
November 2005
Estimated Study Completion Date:
March 2012
Estimated Primary Completion Date:
March 2012 (Final data collection date for primary outcome measure)
1: Experimental
20mg qd citalopram or placebo
Drug: 20mg qd citalopram or placebo
a selective serotonin reuptake inhibitor (SSRI) treatment administered over 16 weeks Detailed
Specific Aims:
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).
To study the relationship between executive function and functional status in patients with early HD after SSRI treatment.
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.
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:
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.
Performance on measures of executive function will be significantly associated with measures of functional status.
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.
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.
Eligibility
Ages Eligible for Study:
Genders Eligible for Study:
Both
Accepts Healthy Volunteers:
No
Criteria
Inclusion Criteria:
Gene positive HD test (or, if untested, an HD diagnosis) with some abnormal motor signs (i.e., diagnostic confidence level of greater than or equal to 2 as measured by the UHDRS).
Aged between 18 and 65
Ability to provide written informed consent
Mild executive dysfunction: participants will be given the Wide Range Achievement Test-4
Age greater than 65
Current major depression at the screening visit or current suicidal ideation.
Any unstable or severe psychiatric disease including DSM-IV-TR diagnoses of schizophrenia, bipolar affective disorder, dementia, delirium, severe anxiety and/or substance abuse/dependence.
Current use of an SSRI or other treatment for depression (e.g., use of an MAOI) or treatment with an SSRI within the past 60 days.
To ensure performance on cognitive measures are not affected by specific concomitant medications, participants taking atypical antipsychotics, kava kava, St. John's Wort, Ginkgo Biloba, or anxiolytics may be excluded unless their dose and dosing frequency have remained stable for 60 days prior to enrollment. Continued participation also requires the dose and dosing frequency remain stable throughout the study
Patients who are pregnant, nursing, or planning to become pregnant during the study.
Patients who are unable to participate in the study assessments (cognitive, functional, psychiatric and motor scales) due to cognitive, motor, or sensory impairments (i.e., significant vision or hearing deficits).
Other serious medical conditions such as cardiovascular or cerebrovascular disease; head injury deemed clinically significant by the PI; neurological disorder or insult other than HD.
Learning disability or other medical condition that is likely to affect cognitive function; history of symptoms indicative of attention deficit hyperactivity disorder (ADHD) in childhood; or a diagnosis of ADHD.
It is important to note that participants who are unable to receive an MRI scan may still participate in this study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271596
Contacts
Contact: William H Adams, B.A.
319-353-4411
William-H-Adams@uiowa.edu
Contact: Amy K Duffy 480-301-4750 Duffy.Amy@mayo.edu
Principal Investigator: John Caviness, M.D.
Recruiting
Iowa City, Iowa, United States, 52242
Contact: William H Adams, B.A. 319-353-4411 William-H-Adams@uiowa.edu
Contact: Nancy L Hale, B.S., R.N. 319-353-4537 Nancy-Hale@uiowa.edu
Principal Investigator: Leigh J Beglinger, Ph.D.
Principal Investigator: Jess G Fiedorowicz, M.D., M.S.
University of Rochester
Recruiting
Rochester, New York, United States, 14618
Contact: Amy Chesire, LCSW-R, MSG 585-341-7519 Amy.Chesire@ctcc.rochester.edu
Principal Investigator: Kevin Biglan, M.D., M.P.H.
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