Citalopram to Enhance Cognition in HD
Condition: Huntington Disease; Chorea; Executive Dysfunction
MeSH terms: Huntington Disease; Chorea
Intervention: 20mg daily citalopram; Placebo
Intervention description: a selective serotonin reuptake inhibitor (SSRI) treatment administered over 16 weeks; a daily matching placebo administered over 16 weeks
Intervention MeSH terms: Citalopram
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Huntington Disease; Citalopram; Celexa; Chorea; Focus; ADD; ADHD; HD; SSRI

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 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.
    

Eligibility 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 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 Criteria:

          -  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