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Citalopram to Enhance Cognition in HD (CIT-HD)

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ClinicalTrials.gov Identifier: NCT00271596
Recruitment Status : Completed
First Posted : January 2, 2006
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Huntington Disease
Chorea
Executive Dysfunction
Interventions Drug: 20mg daily citalopram
Drug: Placebo
Enrollment 33
Recruitment Details 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 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).
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description 20mg daily citalopram Matching daily placebo
Period Title: Overall Study
Started 17 16
Completed 16 15
Not Completed 1 1
Reason Not Completed
Protocol Violation             1             0
Withdrawal by Subject             0             1
Arm/Group Title Citalopram Placebo Total
Hide Arm/Group Description 20mg daily citalopram Matching daily placebo Total of all reporting groups
Overall Number of Baseline Participants 17 16 33
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 17 participants 16 participants 33 participants
47.33  (14.61) 45.13  (13.59) 46.2  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 16 participants 33 participants
Female
8
  47.1%
7
  43.8%
15
  45.5%
Male
9
  52.9%
9
  56.3%
18
  54.5%
1.Primary Outcome
Title Executive Function Composite Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort.
Hide Description Full Scale Name: The Executive Composite Score (ECS). Definition: Subscales were averaged to compute this composite total score. The ECS is the weighted average of performance on 6 subtests of executive function, including (1) the Controlled Oral Word Association Test, (2) Symbol Digit Modalities test; (3) Stroop Color Word Test (Interference Trial), (4) Trail Making test (Part B), (5) Letter-Number Sequencing, and (6) Animal Naming. Construct Measured: Thinking tasks involving planning, working memory, attention, problem solving, verbal reasoning, inhibition, mental flexibility, and task switching. ECS Scale Range: The ECS score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on executive functioning tasks. Change Calculation Details: Compares change in executive functioning performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.005  (0.067) 0.172  (0.071)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.092
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.166
Confidence Interval (2-Sided) 95%
-0.361 to 0.028
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.098
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Letter Number Sequencing Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Full Scale Name: Letter Number Sequencing (LNS) subtest from the Wechsler Adult Intelligence Scale (WAIS) third edition. Definition: LNS is a task that requires the reordering of an initially unordered set of letters and numbers. Construct Measured: Working memory. LNS Score Range: Raw scores may range from 0 to 21, where lower scores indicate poorer performance in working memory. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.113  (0.113) 0.225  (0.124)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.337
Confidence Interval (2-Sided) 95%
-0.672 to -0.003
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.168
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Semantic Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Semantic Fluency Score. Definition: The Semantic Fluency Score is the number of words a person can produce given a category, including naming (1) Animal names, (2) Fruit names, (3) Boy names, (4) Girl names, and (5) Vegetable names. Construct Measured: Working memory and verbal initiation. Scale Range: The Semantic Fluency Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance on working memory tasks. Change Calculation Details: Compares change in working memory performance from visit 2 (week 0) where patients named fruit names to the weighted average of visits 5 (week 12) & 6 (week 15) where patients named girl names and vegetable names respectively for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.386  (0.192) 0.664  (0.187)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.302
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic)
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.278
Confidence Interval (2-Sided) 95%
-0.810 to 0.254
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.268
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Symbol-Digit Modalities Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Full Scale Name: The Symbol Digit Modalities Test (SDMT). Definition: The SDMT screens for organic cerebral dysfunction by having the examinee use a reference key to pair specific numbers with given geometric figures in 90 seconds. Construct Measured: Attention, processing speed, and working memory. SDMT Scale Range: Raw scores may range from 0 to 110, where lower scores indicate poorer performance. Change Calculation Details: Compares change in performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.227  (0.113) -0.170  (0.103)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.708
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.057
Confidence Interval (2-Sided) 95%
-0.361 to 0.246
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.153
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Verbal Fluency Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Full Scale Name: The Verbal Fluency Score (VFC). Definition: The VFC is the number of words a person can produce given a letter, including (1) Naming words that start with F, A, and S; (2) naming words that start with K, W, and R; (3) naming words that start with V, I, and P; (4) naming words that start with O, G, and B; (5) naming words that start with E, N, and T; and (6) naming words that start with J, C, and S. Construct Measured: Verbal initiation and flexibility. Scale Range: The Verbal Fluency Composite Score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in verbal initiation and flexibility from visit 2 (week 0) where patients named words starting with O, G, and B to the weighted average of visits 5 (week 12) and 6 (week 15) where patients named words starting with E, N, and T, and J, C, and S respectively for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.140  (0.109) 0.071  (0.103)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.646
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.069
Confidence Interval (2-Sided) 95%
-0.229 to 0.367
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.150
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Stroop Interference Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Full Scale Name: Stroop Interference subtest from The Stroop Color and Word Test. Definition: Participants are asked to name the ink color in which a word is printed when the word itself (which is irrelevant to the task) is the name of a different color rather than the same color. For example, participants may be asked to say "red" to the word blue printed in red ink. Constructs Measured: Selective attention, response inhibition, cognitive flexibility, and processing speed. Scale Range: The Stroop Interference score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.256  (0.122) -0.046  (0.123)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.230
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.210
Confidence Interval 95%
-0.554 to 0.135
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.174
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Trails B Score Comparing Visit 2 (Week 0) to Visits 5 (Week 12) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Full Scale Name: Trail Making Test Part B (TMT-B). Definition: The TMT-B test requires participants to “connect-the-dots” of 25 consecutive targets on a sheet of paper where the subject alternates between numbers and letters, going in both numerical and alphabetical order. Constructs Measured: Attention, set shifting, and processing speed. Scale range: The TMT-B score ranges from -5 to +5 on a standardized (Z) score scale, where lower scores indicate poorer performance. Change Calculation Details: Compares change in attention and processing speed performance from visit 2 (week 0) to the weighted average of visits 5 (week 12) and 6 (week 15) for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model controlling for practice effects comparing visit 2 (week 0) to the weighted average of visits 5 (week 12) & 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.087  (0.273) 0.405  (0.397)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -0.317
Confidence Interval (2-Sided) 95%
-1.276 to 0.642
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.482
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Hamilton Rating Scale for Depression Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: Compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model comparing screening (intake visit) to Visit 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.67  (0.76) 1.23  (0.89)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.90
Confidence Interval (2-Sided) 95%
-4.30 to 0.50
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.17
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Total Functional Capacity Score Comparing Baseline (Week -4) to Visits 4 (Week 6) & 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Full Scale Name: The Total Functional Capacity (TFC) subscale from the Unified Huntington’s Disease Rating Scale (UHDRS). Definition: The TFC is a score that classifies five stages of Huntington's Disease and five levels of function in the domains of workplace, finances, domestic chores, activities of daily living and requirements for unskilled or skilled care. Construct Measured: Activities of Daily Living. Scale Range: The TFC score ranges from 0 to 13, where lower scores indicate poorer performance in activities of daily living. Change Calculation Details: Compares change in TFC performance from Baseline (week -4) to the weighted average of visits 4 (week 6) and 6 (week 15) for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat analysis was performed using a mixed linear model comparing baseline (week -4) to the weighted average of Visits 4 (week 6) & 6 (week 15) for the citalopram versus placebo cohort
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 16 15
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.54  (0.46) -0.06  (0.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method 2-tailed linear treatment contrast
Comments This was a predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.48
Confidence Interval (2-Sided) 95%
-1.87 to 0.91
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.68
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Subgroup Analysis of the Hamilton Depression Rating Scale Comparing Screening (Intake Visit) to Visit 6 (Week 15) for the Citalopram Cohort Versus Placebo Cohort
Hide Description Full Scale Name: Hamilton Rating Scale for Depression (HAM-D). Definition: The Hamilton Rating Scale for Depression is a clinician-administered multiple item questionnaire used to provide an indication of depression. Construct Measured: Depression. HAM-D Score Range: Raw scores may range from 0 to 54, where higher scores indicate worsening mood. Change Calculation Details: This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.
Time Frame after 15 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis was restricted to a subgroup and, accordingly, does not reflect the total number of participants as reported in the Participant Flow. This analysis compares change in mood from screening (intake visit) to visit 6 (week 15) for the citalopram versus placebo cohort.
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description:
20mg daily citalopram
Matching daily placebo
Overall Number of Participants Analyzed 14 14
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-0.10  (0.85) 1.50  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citalopram, Placebo
Comments Mixed linear model with treatment-group-specific random subject effects: Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments Predefined 2-tailed linear treatment contrast of intention-to-treat, with Kenward-Rogers correction (t statistic).
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value -2.5
Confidence Interval (2-Sided) 95%
-5.04 to 0.04
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.23
Estimation Comments [Not Specified]
Time Frame A systematic assessment of adverse experiences was captured at every encounter beginning at Visit 2 (week 0) and continuing through Visit 7 (week 16) for the randomized treatment vs. placebo period.
Adverse Event Reporting Description 17 Participants were randomized to citalopram and 16 participants were randomized to placebo, using a 1:1 allocation.
 
Arm/Group Title Citalopram Placebo
Hide Arm/Group Description 20mg daily citalopram Matching daily placebo
All-Cause Mortality
Citalopram Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Citalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/17 (5.88%)      2/16 (12.50%)    
Psychiatric disorders     
worsening depression with suicidal ideation   1/17 (5.88%)  1 2/16 (12.50%)  3
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Citalopram Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/17 (35.29%)      3/16 (18.75%)    
Gastrointestinal disorders     
Constipation   1/17 (5.88%)  1 0/16 (0.00%)  0
Dry Mouth   1/17 (5.88%)  1 0/16 (0.00%)  0
General disorders     
Insomnia   1/17 (5.88%)  1 2/16 (12.50%)  2
Nervous system disorders     
Dizziness   2/17 (11.76%)  2 0/16 (0.00%)  0
Headache   0/17 (0.00%)  0 1/16 (6.25%)  1
Reproductive system and breast disorders     
Ejaculation Disorder   1/17 (5.88%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Leigh Beglinger, PhD
Organization: University of Iowa; Elks Rehab Hospital
Phone: 319-353-4489
EMail: leigh-beglinger@elksrehab.org
Publications:
Layout table for additonal information
Responsible Party: Jess G. Fiedorowicz, University of Iowa
ClinicalTrials.gov Identifier: NCT00271596     History of Changes
Other Study ID Numbers: 200509746
5K23NS055733 ( U.S. NIH Grant/Contract )
A-2063 ( Other Identifier: CHDI Foundation )
First Submitted: December 30, 2005
First Posted: January 2, 2006
Results First Submitted: December 19, 2012
Results First Posted: March 13, 2013
Last Update Posted: March 13, 2013