Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
33 participants
INTERVENTIONAL
2005-11-30
2011-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Citalopram
20mg daily citalopram
20mg daily citalopram
a selective serotonin reuptake inhibitor (SSRI) treatment administered over 16 weeks
Placebo
Matching daily placebo
Placebo
a daily matching placebo administered over 16 weeks
Interventions
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20mg daily citalopram
a selective serotonin reuptake inhibitor (SSRI) treatment administered over 16 weeks
Placebo
a daily matching placebo administered over 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Cure Huntington's Disease Initiative (CHDI)
UNKNOWN
University of Rochester
OTHER
Mayo Clinic
OTHER
University of Iowa
OTHER
Responsible Party
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Jess G. Fiedorowicz
Assistant Professor
Principal Investigators
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Leigh J Beglinger, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Iowa Psychiatry Department
Jess G Fiedorowicz, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa Psychiatry Department
Kevin Biglan, M.D., M.P.H.
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
John Caviness, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Ricardo Jorge, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Iowa Psychiatry Department
Locations
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Mayo Clinic Arizona
Scottsdale, Arizona, United States
The University of Iowa
Iowa City, Iowa, United States
University of Rochester
Rochester, New York, United States
Countries
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References
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Aylward EH, Anderson NB, Bylsma FW, Wagster MV, Barta PE, Sherr M, Feeney J, Davis A, Rosenblatt A, Pearlson GD, Ross CA. Frontal lobe volume in patients with Huntington's disease. Neurology. 1998 Jan;50(1):252-8. doi: 10.1212/wnl.50.1.252.
Bauer A, Zilles K, Matusch A, Holzmann C, Riess O, von Horsten S. Regional and subtype selective changes of neurotransmitter receptor density in a rat transgenic for the Huntington's disease mutation. J Neurochem. 2005 Aug;94(3):639-50. doi: 10.1111/j.1471-4159.2005.03169.x.
Bonelli RM, Wenning GK, Kapfhammer HP. Huntington's disease: present treatments and future therapeutic modalities. Int Clin Psychopharmacol. 2004 Mar;19(2):51-62. doi: 10.1097/00004850-200403000-00001.
Como PG, Rubin AJ, O'Brien CF, Lawler K, Hickey C, Rubin AE, Henderson R, McDermott MP, McDermott M, Steinberg K, Shoulson I. A controlled trial of fluoxetine in nondepressed patients with Huntington's disease. Mov Disord. 1997 May;12(3):397-401. doi: 10.1002/mds.870120319.
Duan W, Guo Z, Jiang H, Ladenheim B, Xu X, Cadet JL, Mattson MP. Paroxetine retards disease onset and progression in Huntingtin mutant mice. Ann Neurol. 2004 Apr;55(4):590-4. doi: 10.1002/ana.20075.
Fennema-Notestine C, Archibald SL, Jacobson MW, Corey-Bloom J, Paulsen JS, Peavy GM, Gamst AC, Hamilton JM, Salmon DP, Jernigan TL. In vivo evidence of cerebellar atrophy and cerebral white matter loss in Huntington disease. Neurology. 2004 Sep 28;63(6):989-95. doi: 10.1212/01.wnl.0000138434.68093.67.
Kish SJ, Shannak K, Hornykiewicz O. Elevated serotonin and reduced dopamine in subregionally divided Huntington's disease striatum. Ann Neurol. 1987 Sep;22(3):386-9. doi: 10.1002/ana.410220318.
Menza M, Marin H, Kaufman K, Mark M, Lauritano M. Citalopram treatment of depression in Parkinson's disease: the impact on anxiety, disability, and cognition. J Neuropsychiatry Clin Neurosci. 2004 Summer;16(3):315-9. doi: 10.1176/jnp.16.3.315.
Murman DL, Giordani B, Mellow AM, Johanns JR, Little RJ, Hariharan M, Foster NL. Cognitive, behavioral, and motor effects of the NMDA antagonist ketamine in Huntington's disease. Neurology. 1997 Jul;49(1):153-61. doi: 10.1212/wnl.49.1.153.
Naarding P, Kremer HP, Zitman FG. Huntington's disease: a review of the literature on prevalence and treatment of neuropsychiatric phenomena. Eur Psychiatry. 2001 Dec;16(8):439-45. doi: 10.1016/s0924-9338(01)00604-6.
Patel SV, Tariot PN, Asnis J. L-Deprenyl augmentation of fluoxetine in a patient with Huntington's disease. Ann Clin Psychiatry. 1996 Mar;8(1):23-6. doi: 10.3109/10401239609149087.
Ranen NG, Lipsey JR, Treisman G, Ross CA. Sertraline in the treatment of severe aggressiveness in Huntington's disease. J Neuropsychiatry Clin Neurosci. 1996 Summer;8(3):338-40. doi: 10.1176/jnp.8.3.338.
Reynolds GP, Dalton CF, Tillery CL, Mangiarini L, Davies SW, Bates GP. Brain neurotransmitter deficits in mice transgenic for the Huntington's disease mutation. J Neurochem. 1999 Apr;72(4):1773-6. doi: 10.1046/j.1471-4159.1999.721773.x.
Reynolds GP, Pearson SJ. Decreased glutamic acid and increased 5-hydroxytryptamine in Huntington's disease brain. Neurosci Lett. 1987 Jul 22;78(2):233-8. doi: 10.1016/0304-3940(87)90639-2.
Rosas HD, Koroshetz WJ, Chen YI, Skeuse C, Vangel M, Cudkowicz ME, Caplan K, Marek K, Seidman LJ, Makris N, Jenkins BG, Goldstein JM. Evidence for more widespread cerebral pathology in early HD: an MRI-based morphometric analysis. Neurology. 2003 May 27;60(10):1615-20. doi: 10.1212/01.wnl.0000065888.88988.6e.
Shoulson I, Goldblatt D, Charlton M, Joynt RJ. Huntington's disease: treatment with muscimol, a GABA-mimetic drug. Ann Neurol. 1978 Sep;4(3):279-84. doi: 10.1002/ana.410040316.
Yohrling IV GJ, Jiang GC, DeJohn MM, Robertson DJ, Vrana KE, Cha JH. Inhibition of tryptophan hydroxylase activity and decreased 5-HT1A receptor binding in a mouse model of Huntington's disease. J Neurochem. 2002 Sep;82(6):1416-23. doi: 10.1046/j.1471-4159.2002.01084.x.
Beglinger LJ, Adams WH, Fiedorowicz JG, Duff K, Langbehn D, Biglan K, Caviness J, Olson B, Paulsen JS. Practice Effects and Stability of Neuropsychological and UHDRS Tests Over Short Retest Intervals in Huntington Disease. J Huntingtons Dis. 2015;4(3):251-60. doi: 10.3233/JHD-150159.
Beglinger LJ, Adams WH, Langbehn D, Fiedorowicz JG, Caviness J, Biglan K, Olson B, Paulsen JS. Does interval between screening and baseline matter in HD cognitive clinical trials? J Huntingtons Dis. 2014;3(2):139-44. doi: 10.3233/JHD-140100.
Beglinger LJ, Adams WH, Langbehn D, Fiedorowicz JG, Jorge R, Biglan K, Caviness J, Olson B, Robinson RG, Kieburtz K, Paulsen JS. Results of the citalopram to enhance cognition in Huntington disease trial. Mov Disord. 2014 Mar;29(3):401-5. doi: 10.1002/mds.25750. Epub 2013 Dec 27.
Related Links
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The University of Iowa's Huntington's Disease Center of Excellence
Other Identifiers
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A-2063
Identifier Type: OTHER
Identifier Source: secondary_id
200509746
Identifier Type: -
Identifier Source: org_study_id
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