Trial · NCT00223236
Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
NCT00223236, Phase 3, Completed, University of Texas Southwestern Medical Center; results first posted 2014-08-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence. Trials, record NCT00223236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00223236
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence
- NCT number
- NCT00223236
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Mania, Hypomania, Cocaine Abuse, Cocaine Dependence
- Interventions
- Citicoline, Placebo
- First posted
- 2005-09-22
- Last updated
- 2014-08-11
- Results first posted
- 2014-08-11
- Limitations and caveats
- Low retention rate in the end of study (12 weeks) leading to a potential underestimation of treatment effectiveness.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cocaine Use Determined by Urine Analysis | Biweekly (visit) urine drug screens | 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. |
| Secondary | Inventory of Depressive Symptomatology Self Report (IDS-SR). | Change in scores between baseline and exit (exit - baseline). | 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). |
| Secondary | Young Mania Rating Scale(YMRS). | Baseline to exit (exit score - baseline score) | 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). |
| Secondary | Rey Auditory Verbal Learning Test(RAVLT) | Change in T scores between baseline and exit (exitT score - baseline T score). | 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). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cocaine Use Determined by Urine Analysis | Biweekly (visit) urine drug screens | Number of participants are those who completed baseline assessment and at least one treatment visit followed by baseline. | percentage of participants no cocaine | NUMBER |
| SECONDARY | Inventory of Depressive Symptomatology Self Report (IDS-SR). | Change in scores between baseline and exit (exit - baseline). | Number of participants reported are those who completed baseline assessment and at least one treatment visit. | units on scale | MEAN |
| SECONDARY | Young Mania Rating Scale(YMRS). | Baseline to exit (exit score - baseline score) | Numbers of participants are those who completed baseline assessment and at least one treatment visit. | units on a scale | MEAN |
| SECONDARY | Rey Auditory Verbal Learning Test(RAVLT) | Change in T scores between baseline and exit (exitT score - baseline T score). | number of participants are calculated based on those who completed baseline and at least one treatment visit. | T score | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cocaine Use Determined by Urine Analysis | Citicoline | 62.50 | percentage of participants no cocaine | ||
| Cocaine Use Determined by Urine Analysis | Placebo | 50.00 | percentage of participants no cocaine | ||
| Inventory of Depressive Symptomatology Self Report (IDS-SR). | Citicoline | -20.54 | Standard Deviation 14.56 | units on scale | |
| Inventory of Depressive Symptomatology Self Report (IDS-SR). | Placebo | -11.89 | Standard Deviation 14.45 | units on scale | |
| Young Mania Rating Scale(YMRS). | Citicoline | -2.00 | Standard Deviation 8.03 | units on a scale | |
| Young Mania Rating Scale(YMRS). | Placebo | -2.88 | Standard Deviation 5.68 | units on a scale | |
| Rey Auditory Verbal Learning Test(RAVLT) | Citicoline | 7.06 | Standard Deviation 11.79 | T score | |
| Rey Auditory Verbal Learning Test(RAVLT) | Placebo | 3.14 | Standard Deviation 7.07 | T score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Citicoline | 16 | |
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | COMPLETED | Citicoline | 9 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | NOT COMPLETED | Citicoline | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 14 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Skin rash | Skin and subcutaneous tissue disorders | Citicoline | 1 | 23 | 1 |
| serious | Skin rash | Skin and subcutaneous tissue disorders | Placebo | 1 | 21 | 1 |
| serious | Hypomania | Psychiatric disorders | Citicoline | 0 | 23 | 0 |
| serious | Hypomania | Psychiatric disorders | Placebo | 1 | 21 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Citicoline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Citicoline | 0 | 23 |
| Total, other adverse events | Placebo | 0 | 21 |
| Total, serious adverse events | Citicoline | 1 | 23 |
| Total, serious adverse events | Placebo | 2 | 21 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Citicoline vs Placebo: serious adverse events |
Source Trial comparisons
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Verbal Learning | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00223236
GET https://conductscience.org/api/trials/v1/NCT00223236/registered