A Phase 3 interventional study of Citicoline and Placebo in Mania, Hypomania and Cocaine Abuse, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-08-11.
Sponsored by University of Texas Southwestern Medical Center · Phase 3, Interventional, and Treatment
The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.
Forty-four outpatients meeting the inclusion and exclusion criteria were enrolled after completing an Institutional Review Board (IRB)-approved informed consent process. Baseline evaluation included a medical and psychiatric history, structured diagnostic interview using Diagnostic and Statistical Manual (DSM)-IV criteria, mood assessment with the Inventory of Depressive Symptomatology-Self Report (IDS-SR), Young Mania Rating Scale (YMRS), and cognitive assessment with the Rey Auditory Verbal Learning Test (RAVLT). Alternate but equivalent versions of the RAVLT were used to minimize practice effects with repeated administration. Cocaine use was assessed at each biweekly visit with urine drug screens. Citicoline or placebo was given beginning at one tablet (500 mg)/day with an increase to two tablets (1000 mg/day) at week 2, three tablets (1500 mg/day) at week 4, and four tablets (2000 mg/day) at week 6. Doses were decreased, if needed, due to side effects.
97 studies on the registry are indexed under Mania; 10 are open to participants now.
This study's enrollment of 44 is below the median of 86 across 86 interventional studies indexed under Mania.
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Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Exclusion Criteria:
Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
Drug: Citicoline
Inactive ingredient matching the active medication in appearance
Drug: Placebo
Citicoline or placebo will be given beginning at one table (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 will remain on 2000mg/day through week 12. Doses will be decreased if needed due to side effects.
Also known as: Cytidine-5'-diphosphocholine, CDP-choline
Placebo matching active medication in all other aspects.
Also known as: Identical placebo
Cocaine Use Determined by Urine Analysis
Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks.
Time frame: Biweekly (visit) urine drug screens
Inventory of Depressive Symptomatology Self Report (IDS-SR).
The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. The each item has a 4-likert scale, 0 to 3, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the tudy period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).
Time frame: Change in scores between baseline and exit (exit - baseline).
Young Mania Rating Scale(YMRS).
The YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal and and 4 or 8 =most abnormal. The total possible score is 0 to 60, 0 being no symptom and 60 the worst symptom. The higher the score, the worse the mania symptoms are. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).
Time frame: Baseline to exit (exit score - baseline score)
Rey Auditory Verbal Learning Test(RAVLT)
The RAVLT consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. The total score is the total number of words recalled through the five trials. Normative RAVLT T-scores was used. the higher T score, the better memory. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in RAVLT T scores between baseline and exit (exit - baseline).
Time frame: Change in T scores between baseline and exit (exitT score - baseline T score).
Patients were recruited from local community behavioral healthcare clinics and through advertising in local publications. The recruitment period was from 5/1/2004 to 4/12/2005.
| Milestone | Citicoline | Placebo |
|---|---|---|
| Started | 16 | 18 |
| Completed | 9 | 4 |
| Not completed | 7 | 14 |
Urine drug screens were administered at each visit to detect cocaine in urine. If negative according to urine analysis, it is determined as no cocaine use and if positive, cocaine use. Percentage of participants with no cocaine detected in urine at exit is an outcome measuring treatment effectiveness. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks.
| percentage of participants no cocaine | Citicoline | Placebo |
|---|---|---|
| Cocaine Use Determined by Urine Analysis | 62.50 | 50.00 |
The IDS-SR is a 30 item self report used to assess the severity of depressive symptoms. The each item has a 4-likert scale, 0 to 3, with 3 representing the worst symptom. The total score of IDS-SR is calculated as a sum of each item score. The range of possible score is between 0 and 90, 0 as no symptom and 90 the worst symptom. The higher the score, the more severe the depression. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the tudy period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).
| units on scale | Citicoline | Placebo |
|---|---|---|
| Inventory of Depressive Symptomatology Self Report (IDS-SR). | -20.54 ± 14.56 | -11.89 ± 14.45 |
The YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal and and 4 or 8 =most abnormal. The total possible score is 0 to 60, 0 being no symptom and 60 the worst symptom. The higher the score, the worse the mania symptoms are. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in scores between baseline and exit (exit - baseline).
| units on a scale | Citicoline | Placebo |
|---|---|---|
| Young Mania Rating Scale(YMRS). | -2.00 ± 8.03 | -2.88 ± 5.68 |
The RAVLT consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. The total score is the total number of words recalled through the five trials. Normative RAVLT T-scores was used. the higher T score, the better memory. Exit week is defined as the last week of treatment. It varied between 2 week an 12 weeks with an average exit week of 10 week and 7 week for the citicoline treatment and placebo groups, respectively. Allowing unequal week of treatment period in measuring outcome enables us to include most participants due to a low retention rate in the end of the study period, 12 weeks. The outcome was measured by change in RAVLT T scores between baseline and exit (exit - baseline).
| T score | Citicoline | Placebo |
|---|---|---|
| Rey Auditory Verbal Learning Test(RAVLT) | 7.06 ± 11.79 | 3.14 ± 7.07 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Citicoline | — | 1/23 (4.3%) | 0/23 (0%) |
| Placebo | — | 2/21 (9.5%) | 0/21 (0%) |
| Event | Citicoline | Placebo |
|---|---|---|
| Skin rashSkin and subcutaneous tissue disorders | 1/23 | 1/21 |
| HypomaniaPsychiatric disorders | 0/23 | 1/21 |
Number of paticipants who completed baseline assessment
| Age, Categorical(Participants) | Citicoline | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 21 | 44 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Citicoline | Placebo | Total |
|---|---|---|---|
| Mean | 42.1 ± 6.6 | 40.7 ± 8.0 | 41.4 ± 7.1 |
| Sex: Female, Male(Participants) | Citicoline | Placebo | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 13 | 10 | 23 |
| Region of Enrollment(participants) | Citicoline | Placebo | Total |
|---|---|---|---|
| United States | 23 | 21 | 44 |
| Inventory of Depressive Symptomatology(Units on a scale) | Citicoline | Placebo | Total |
|---|---|---|---|
| Mean | 43.6 ± 10.6 | 38.7 ± 13 | 41.26 ± 11.9 |
| Young Mania Rating Scale(Units on a scale) | Citicoline | Placebo | Total |
|---|---|---|---|
| Mean | 11.2 ± 4.9 | 11.5 ± 7.0 | 11.34 ± 5.89 |
| Rey Auditory Verbal Learning Scale(T scores) | Citicoline | Placebo | Total |
|---|---|---|---|
| Mean | 36.6 ± 10.0 | 36.0 ± 9.0 | 36.33 ± 9.47 |
| cocaine used(participants) | Citicoline | Placebo | Total |
|---|---|---|---|
| No cocaine used | 19 | 19 | 38 |
| Cocaine used | 4 | 1 | 5 |
| Unknown | 0 | 1 | 1 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center