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An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia

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ClinicalTrials.gov Identifier: NCT01716221
Recruitment Status : Completed
First Posted : October 29, 2012
Results First Posted : September 19, 2016
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Friedreich Ataxia
Interventions Drug: bupropion & Citalopram
Drug: Bupropion & Placebo
Drug: Placebo & Citalopram
Drug: Placebo & Placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Study Participant
Hide Arm/Group Description the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Study Participant
Hide Arm/Group Description the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
1
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
65  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
1
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants
1
1.Primary Outcome
Title International Cooperative Ataxia Rating Scale (ICARS)
Hide Description The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease.
Time Frame Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupropion & Citalopram Bupropion & Placebo Placebo & Citalopram Placebo & Placebo Baseline
Hide Arm/Group Description:

100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day or 50mg Bupropion & 10mg Citalopram taken orally one time per day

bupropion & Citalopram

100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day

Bupropion & Placebo

Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day

Placebo & Citalopram

Placebo & Placebo taken orally one time per day

Placebo & Placebo

unblinded 100mg Bupropion & 20mg Citalopram
Overall Number of Participants Analyzed 1 1 1 1 1
Measure Type: Number
Unit of Measure: units
39 30 47 46 42
2.Primary Outcome
Title Friedreich Ataxia Rating Scale (FARS)
Hide Description A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease.
Time Frame Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline - Unblinded on Buproprion and Citalopram Citalopram (Week 5) OFF - Bupropion Placebo + Citalopram Placebo (Week 10) Bupropion Only (Week 15) Bupropion + Citalopram (Week 20)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1 1 1 1
Measure Type: Number
Unit of Measure: points
43 41 47 42 45
3.Secondary Outcome
Title Comparison of FARS and ICARS
Hide Description Differences between FARS - ICARS at each treatment interval
Time Frame Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline - Unblinded on Buproprion and Citalopram Citalopram (Week 5) OFF - Bupropion Placebo + Citalopram Placebo (Week 10) Bupropion Only (Week 15) Bupropion + Citalopram (Week 20)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1 1 1 1
Measure Type: Number
Unit of Measure: points
1 -6 1 12 6
4.Other Pre-specified Outcome
Title Hamilton Depression Rating Scale
Hide Description The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression.
Time Frame Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline - Unblinded on Buproprion and Citalopram Citalopram (Week 5) OFF - Bupropion Placebo + Citalopram Placebo (Week 10) Bupropion Only (Week 15) Bupropion + Citalopram (Week 20)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1 1 1 1 1
Measure Type: Number
Unit of Measure: units on a scale
7 10 2 3 4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bupropion & Citalopram Bupropion & Placebo Placebo & Citalopram Placebo & Placebo
Hide Arm/Group Description

100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day

bupropion & Citalopram

100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day

Bupropion & Placebo

Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day

Placebo & Citalopram

Placebo & Placebo taken orally one time per day

Placebo & Placebo

All-Cause Mortality
Bupropion & Citalopram Bupropion & Placebo Placebo & Citalopram Placebo & Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bupropion & Citalopram Bupropion & Placebo Placebo & Citalopram Placebo & Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupropion & Citalopram Bupropion & Placebo Placebo & Citalopram Placebo & Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Olga Klepitskaya
Organization: University of Colorado
Phone: 303-724-8984
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01716221     History of Changes
Other Study ID Numbers: 11-1141
First Submitted: October 25, 2012
First Posted: October 29, 2012
Results First Submitted: March 11, 2016
Results First Posted: September 19, 2016
Last Update Posted: September 19, 2016