Citalopram to Enhance Cognition in HD
Information source: University of Iowa
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Huntington Disease; Chorea; Executive Dysfunction
Intervention: 20mg daily citalopram (Drug); Placebo (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: University of Iowa Official(s) and/or principal investigator(s): Leigh J Beglinger, Ph.D., Principal Investigator, Affiliation: The University of Iowa Psychiatry Department Jess G Fiedorowicz, M.D., Ph.D., Principal Investigator, Affiliation: University of Iowa Psychiatry Department Kevin Biglan, M.D., M.P.H., Principal Investigator, Affiliation: University of Rochester John Caviness, M.D., Principal Investigator, Affiliation: Mayo Clinic Ricardo Jorge, M.D., Principal Investigator, Affiliation: University of Iowa Psychiatry Department
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.
Clinical Details
Official title: A Randomized, Placebo-Controlled Pilot Study in Huntington's Disease (CIT-HD)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort.
Secondary outcome: Letter Number Sequencing Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo CohortSemantic Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort Symbol-Digit Modalities Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort Verbal Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort Stroop Interference Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort Trails B Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort Hamilton Rating Scale for Depression Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort Total Functional Capacity Score Comparing Baseline (Week -4) to Visits 4 (Week 6) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort Subgroup Analysis of the Hamilton Depression Rating Scale Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Mayo Clinic Arizona, Scottsdale, Arizona 85259, United States
The University of Iowa, Iowa City, Iowa 52242, United States
University of Rochester, Rochester, New York 14618, United States
Additional Information
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Starting date: November 2005
Last updated: February 8, 2013
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