Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00271596
Status:
COMPLETED
Last Update Posted:
2013-03-13
First Post:
2005-12-30
Brief Title:
Citalopram to Enhance Cognition in HD
Sponsor:
University of Iowa
Organization:
University of Iowa
Study Overview
Official Title:
A Randomized Placebo-Controlled Pilot Study in Huntingtons Disease CIT-HD
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIT-HD
Brief Summary:
This research plan proposes to conduct a double-blind placebo-controlled pilot clinical trial in 36 adults with mild Huntingtons 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 ie N-acetyl-aspartate concentration measures in the neostriatum among patients with recently diagnosed Huntingtons disease
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 ie N-acetyl-aspartate concentration measures in the neostriatum among patients with recently diagnosed Huntingtons 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 Huntingtons 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 ie N-Acetyl-Aspartate concentration measures in the neostriatum among patients with recently diagnosed Huntingtons 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 Huntingtons Disease will show greater changes from baseline on volumetric and metabolic ie N-Acetyl-Aspartate concentration neuroimaging measures in the neostriatum than those on placebo
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 Huntingtons 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 ie N-Acetyl-Aspartate concentration measures in the neostriatum among patients with recently diagnosed Huntingtons 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 Huntingtons Disease will show greater changes from baseline on volumetric and metabolic ie N-Acetyl-Aspartate concentration neuroimaging measures in the neostriatum than those on placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A-2063 | OTHER | CHDI Foundation | httpsreporternihgovquickSearch5K23NS055733 |
| 5K23NS055733 | NIH | None | None |