Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00377299
Recruitment Status : Completed
First Posted : September 18, 2006
Results First Posted : August 8, 2013
Last Update Posted : August 8, 2013
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Amphetamine Abuse
Amphetamine Dependence
Bipolar Disorder
Major Depressive Disorder
Interventions Drug: Citicoline
Drug: Placebo
Enrollment 60
Recruitment Details Sixty depressed outpatients with methamphetamine dependence were enrolled and randomized for 12 weeks of acute treatment after completing an IRB-approved written informed consent The study was conducted at the UT Southwestern Medical Center in Dallas. The first participant was enrolled on 10/11/06 and the final assessment was on 4/7/09.
Pre-assignment Details  
Arm/Group Title Citicoline Placebo
Hide Arm/Group Description Citicoline add-on therapy was given beginning at one tablet(500mg/day) with an increase to two tablets(1000mg/day) at week 2, three tablets(1500mg/day)at week 4 and four tablets (2000mg/day) at week 6. Patients remained on 2000mg/day throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects. Placebo identical in appearance to the medication was given beginning at one tablet with an increase to two tablets at week 2, three tablets at week 4 and four tablets at week 6. Patients remained on four tables throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
Period Title: Overall Study
Started 32 28
Completed 13 4
Not Completed 19 24
Reason Not Completed
Lost to Follow-up             14             19
Adverse Event             0             1
Withdrawal by Subject             5             4
Arm/Group Title Citicoline Placebo Total
Hide Arm/Group Description Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 32 28 60
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 28 participants 60 participants
41.0  (9.6) 34.0  (7.4) 37.8  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
Female
17
  53.1%
11
  39.3%
28
  46.7%
Male
15
  46.9%
17
  60.7%
32
  53.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 28 participants 60 participants
American Indian or Alaska Native
0
   0.0%
1
   3.6%
1
   1.7%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
28
  87.5%
20
  71.4%
48
  80.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  12.5%
7
  25.0%
11
  18.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 28 participants 60 participants
32 28 60
1.Primary Outcome
Title Depression Symptoms
Hide Description Inventory of Depressive Symptomatology-Clinician Rated (IDS-C), (a clinician-administered depression scale) is used to assess the severity of depressive symptoms.Scores can range from 0 to 84. The higher the score, the worse the depressive symptoms(worse outcome).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The intent to treat (ITT) group includes all who returned for at least one post baseline visit. Analysis uses Last Observation Carried Forward (LOCF) method.
Arm/Group Title Citicoline Placebo
Hide Arm/Group Description:
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Placebo.
Overall Number of Participants Analyzed 28 20
Mean (Standard Error)
Unit of Measure: scores on a scale
26.2  (2.5) 33.1  (3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citicoline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments Significance was set at a p value of ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Amphetamine Craving
Hide Description Visual Analog Scale (VAS) assessing Methamphetamine craving with a 1-100 scale.Higher values on the VAS scale indicate a higher Methamphetamine craving(worse outcome).
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT includes those returning for at least one post baseline visit. LOCF used for end point data.
Arm/Group Title Citicoline Placebo
Hide Arm/Group Description:
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Placebo.
Overall Number of Participants Analyzed 19 27
Mean (Standard Error)
Unit of Measure: scores on a scale
31.9  (8.0) 44.1  (9.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citicoline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Significance was set at a p value of ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Amphetamine Use
Hide Description Participant reported days per 7-day week of methamphetamine use.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT includes those returning for at least one post baseline visit. LOCF used for end point data.
Arm/Group Title Citicoline Placebo
Hide Arm/Group Description:
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Placebo matching Citicoline.
Overall Number of Participants Analyzed 28 20
Mean (Standard Error)
Unit of Measure: days per week
2.9  (0.6) 2.3  (0.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citicoline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Significance was set at a p value of ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Hopkins Auditory Verbal Learning Test (HVLT)
Hide Description The Hopkins Auditory Verbal Learning Test (HVLT) is a measure of cognition (memory/recall). Raw scores are derived for Total Recall, Delayed Recall, Retention (% retained), and a Recognition Discrimination Index. Raw scores are calculated into T-scores. T-scores are standardized scores on each dimension for each type. A score of 50 represents the mean. A difference of 10 from the mean indicates a difference of one standard deviation. Thus, a score of 60 is one standard deviation above the mean, while a score of 30 is two standard deviations below the mean.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT includes those returning for at least one post baseline visit. LOCF used for end point data.
Arm/Group Title Citicoline Placebo
Hide Arm/Group Description:
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Placebo matching Citicoline.
Overall Number of Participants Analyzed 17 9
Mean (Standard Error)
Unit of Measure: T score
38.5  (3.8) 47.5  (4.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citicoline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Significance was set at a p value of ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Stroop Color Word Test
Hide Description The Stroop Color Word Test measures the individual's ability to separate the word and color naming stimuli thus the ability to sort information from the environment and selectively react to this information. The scoring is a measure of time to complete 100 items and the numbers of items that can be completed. THe scores are converted into T-scores which have a mean of 50 and a standard deviation of 10.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Citicoline Placebo
Hide Arm/Group Description:
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Placebo.
Overall Number of Participants Analyzed 28 20
Mean (Standard Error)
Unit of Measure: T score
56.2  (2.6) 54.3  (3.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Citicoline, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Significance was set at a p value of ≤ 0.05.
Method ANCOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Citicoline Placebo
Hide Arm/Group Description Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects. [Not Specified]
All-Cause Mortality
Citicoline Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Citicoline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/32 (3.13%)      4/28 (14.29%)    
Injury, poisoning and procedural complications     
Injuries Due to Car Accident  [1]  1/32 (3.13%)  1 0/28 (0.00%)  0
Drug Overdose  [2]  0/32 (0.00%)  0 1/28 (3.57%)  1
Car Accident  [1]  0/32 (0.00%)  0 1/28 (3.57%)  1
Psychiatric disorders     
Drug Overdose / Suicidal Gesture  [2]  0/32 (0.00%)  0 1/28 (3.57%)  1
Psychiatric Hospitalization Involuntary  [3]  0/32 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
[1]
Participant was in a motor vehicle accident.
[2]
Overdose.
[3]
Psychiatric hospitalization.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Citicoline Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/32 (6.25%)      0/28 (0.00%)    
Infections and infestations     
Tooth Abscess and Infection  [1]  1/32 (3.13%)  1 0/28 (0.00%)  0
Psychiatric disorders     
Severe Panic Attack  [2]  1/32 (3.13%)  1 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Participant reported an abscessed/infected tooth and received amoxycillin.
[2]
Participant with a history of panic attacks experienced a severe panic attack. Attack resolved without need for medical intervention.
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: Dr. E. Sherwood Brown, M.D., Ph.D.
Organization: UT Southwestern Medical Center at Dallas
Phone: 214-645-6950
EMail: sherwood.brown@utsouthwestern.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00377299    
Other Study ID Numbers: 052006-27
First Submitted: September 14, 2006
First Posted: September 18, 2006
Results First Submitted: September 8, 2011
Results First Posted: August 8, 2013
Last Update Posted: August 8, 2013