Status:
COMPLETED
Citalopram to Enhance Cognition in HD
Lead Sponsor:
University of Iowa
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Cure Huntington's Disease Initiative (CHDI)
Conditions:
Huntington Disease
Chorea
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 ear...
Eligibility Criteria
Inclusion
- 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 1 as measured by the UHDRS).
- Aged between 18 and 75
- Ability to provide written informed consent
- Mild stage HD (Shoulson and Fahn Scale Stage 1 or 2)
- Mild executive dysfunction: Participants must have complaints of poor cognition, mild functional decline, or demonstrate objective evidence of decline from their premorbid level
- Participants are able to complete all study assessments
Exclusion
- Age under 18 or greater than 75
- Current major depression deemed significant by the investigator at the screening visit or current suicidal ideation.
- Any unstable or severe psychiatric disease including 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 14 days.
- Current use of St. John's wort within the past 14 days.
- To ensure performance on cognitive measures are not affected by specific concomitant medications, participants taking methylphenidate, amphetamine/dextroamphetamine, atomoxetine, an acetyl cholinesterase inhibitor, an atypical antipsychotic, kava kava, Ginkgo Biloba, or an anxiolytic drug may be excluded unless their dose and dosing frequency have remained stable for 30 days prior to receiving study drug. 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00271596
Start Date
November 1 2005
End Date
November 1 2011
Last Update
March 13 2013
Active Locations (3)
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1
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
2
The University of Iowa
Iowa City, Iowa, United States, 52242
3
University of Rochester
Rochester, New York, United States, 14618