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Citalopram to Enhance Cognition in HD (CIT-HD)

This study has been completed.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Cure Huntington's Disease Initiative (CHDI)
University of Rochester
Mayo Clinic
Information provided by (Responsible Party):
Jess G. Fiedorowicz, University of Iowa
ClinicalTrials.gov Identifier:
NCT00271596
First received: December 30, 2005
Last updated: February 8, 2013
Last verified: February 2013
History of Changes
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Huntington Disease
Chorea
Executive Dysfunction
Interventions: Drug: 20mg daily citalopram
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Thirty-six individuals were screened and 33 participants were randomized between May 2007 and April 2011 Participants were recruited using advertisements, by speaking at HD events, through local clinics and through two HD registries: The University of Iowa HD registry and the National HD Research Roster (Indiana).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following the baseline visit, participants completed a study visit (i.e., Visit 01) after 2 weeks in order to wash-out practice effects on primary outcome measures. To further control for practice effects, participants received placebo for 14 days prior to randomization (i.e., using a placebo run-in design).

Reporting Groups
  Description
Citalopram 20mg daily citalopram
Placebo Matching daily placebo

Participant Flow:   Overall Study
    Citalopram     Placebo  
STARTED     17     16  
COMPLETED     16     15  
NOT COMPLETED     1     1  
Protocol Violation                 1                 0  
Withdrawal by Subject                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Citalopram 20mg daily citalopram
Placebo Matching daily placebo
Total Total of all reporting groups

Baseline Measures
    Citalopram     Placebo     Total  
Number of Participants  
[units: participants]
 		  17     16     33  
Age  
[units: years]
Mean ± Standard Deviation 		     
Age     47.33  ± 14.61     45.13  ± 13.59     46.2  ± 13.9  
Gender  
[units: participants]
 		     
Female     8     7     15  
Male     9     9     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort.   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 1

2.  Secondary:   Letter Number Sequencing Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 2

3.  Secondary:   Semantic Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 3

4.  Secondary:   Symbol-Digit Modalities Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 4

5.  Secondary:   Verbal Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 5

6.  Secondary:   Stroop Interference Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 6

7.  Secondary:   Trails B Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 7

8.  Secondary:   Hamilton Rating Scale for Depression Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 8

9.  Secondary:   Total Functional Capacity Score Comparing Baseline (Week -4) to Visits 4 (Week 6) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 9

10.  Secondary:   Subgroup Analysis of the Hamilton Depression Rating Scale Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort   [ Time Frame: after 15 weeks of treatment ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Statistical power was limited.  


Results Point of Contact:  
Name/Title: Leigh Beglinger, PhD
Organization: University of Iowa; Elks Rehab Hospital
phone: 319-353-4489
e-mail: leigh-beglinger@elksrehab.org


Publications:


Responsible Party: Jess G. Fiedorowicz, University of Iowa
ClinicalTrials.gov Identifier: NCT00271596     History of Changes
Other Study ID Numbers: 200509746, 5K23NS055733, A-2063
Study First Received: December 30, 2005
Results First Received: December 19, 2012
Last Updated: February 8, 2013
Health Authority: United States: Federal Government