Citalopram to Enhance Cognition in HD
Condition: Huntington Disease; Chorea; Executive Dysfunction
MeSH terms: Huntington Disease; Chorea
Study type: Interventional
Phase: Phase 2

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.
    

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 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, 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, 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 occipital proton magnetic resonance spectroscopy (1H-MRS),
           after 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.
    

Intervention name(s): 20mg daily citalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): a selective serotonin reuptake inhibitor (SSRI) treatment administered over 16 weeks; a daily matching placebo administered over 16 weeks
Other intervention name(s): Celexa; Matching daily placebo
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Huntington Disease; Citalopram; Celexa; Chorea; Focus; ADD; ADHD; HD; SSRI