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

NCT00377299, Not applicable, Completed, University of Texas Southwestern Medical Center; results first posted 2013-08-08

Trial 11

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Field	Value	Source
Title	A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence	ClinicalTrials.gov
NCT number	NCT00377299	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Not applicable	ClinicalTrials.gov
Enrollment	60 participants, actual	ClinicalTrials.gov
Lead sponsor	University of Texas Southwestern Medical Center	ClinicalTrials.gov
Conditions	Amphetamine Abuse, Amphetamine Dependence, Bipolar Disorder, Major Depressive Disorder	ClinicalTrials.gov
Interventions	Citicoline, Placebo	ClinicalTrials.gov
First posted	2006-09-18	ClinicalTrials.gov
Last updated	2013-08-08	ClinicalTrials.gov
Results first posted	2013-08-08	ClinicalTrials.gov

Registered outcomes 5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description	Source
Primary	Depression Symptoms	12 weeks	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).	ClinicalTrials.gov
Secondary	Amphetamine Craving	12 Weeks	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).	ClinicalTrials.gov
Secondary	Amphetamine Use	12 weeks	Participant reported days per 7-day week of methamphetamine use.	ClinicalTrials.gov
Secondary	Hopkins Auditory Verbal Learning Test (HVLT)	12 weeks	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.	ClinicalTrials.gov
Secondary	Stroop Color Word Test	12 weeks	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.	ClinicalTrials.gov

Outcomes 5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as	Source
PRIMARY	Depression Symptoms	12 weeks	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.	scores on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Amphetamine Craving	12 Weeks	ITT includes those returning for at least one post baseline visit. LOCF used for end point data.	scores on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Amphetamine Use	12 weeks	ITT includes those returning for at least one post baseline visit. LOCF used for end point data.	days per week	MEAN	ClinicalTrials.gov
SECONDARY	Hopkins Auditory Verbal Learning Test (HVLT)	12 weeks	ITT includes those returning for at least one post baseline visit. LOCF used for end point data.	T score	MEAN	ClinicalTrials.gov
SECONDARY	Stroop Color Word Test	12 weeks		T score	MEAN	ClinicalTrials.gov

Results by group 10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units	Source
Depression Symptoms	Citicoline	26.2	Standard Error 2.5	scores on a scale	ClinicalTrials.gov
Depression Symptoms	Placebo	33.1	Standard Error 3.0	scores on a scale	ClinicalTrials.gov
Amphetamine Craving	Citicoline	31.9	Standard Error 8.0	scores on a scale	ClinicalTrials.gov
Amphetamine Craving	Placebo	44.1	Standard Error 9.7	scores on a scale	ClinicalTrials.gov
Amphetamine Use	Citicoline	2.9	Standard Error 0.6	days per week	ClinicalTrials.gov
Amphetamine Use	Placebo	2.3	Standard Error 0.5	days per week	ClinicalTrials.gov
Hopkins Auditory Verbal Learning Test (HVLT)	Citicoline	38.5	Standard Error 3.8	T score	ClinicalTrials.gov
Hopkins Auditory Verbal Learning Test (HVLT)	Placebo	47.5	Standard Error 4.7	T score	ClinicalTrials.gov
Stroop Color Word Test	Citicoline	56.2	Standard Error 2.6	T score	ClinicalTrials.gov
Stroop Color Word Test	Placebo	54.3	Standard Error 3.1	T score	ClinicalTrials.gov

Participant flow 6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Citicoline	32	ClinicalTrials.gov
Overall Study	STARTED	Placebo	28	ClinicalTrials.gov
Overall Study	COMPLETED	Citicoline	13	ClinicalTrials.gov
Overall Study	COMPLETED	Placebo	4	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Citicoline	19	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Placebo	24	ClinicalTrials.gov

Adverse events 14

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	Source
other	Severe Panic Attack	Psychiatric disorders	Citicoline	1	32	1	ClinicalTrials.gov
other	Severe Panic Attack	Psychiatric disorders	Placebo	0	28	0	ClinicalTrials.gov
other	Tooth Abscess and Infection	Infections and infestations	Citicoline	1	32	1	ClinicalTrials.gov
other	Tooth Abscess and Infection	Infections and infestations	Placebo	0	28	0	ClinicalTrials.gov
serious	Injuries Due to Car Accident	Injury, poisoning and procedural complications	Citicoline	1	32	1	ClinicalTrials.gov
serious	Injuries Due to Car Accident	Injury, poisoning and procedural complications	Placebo	0	28	0	ClinicalTrials.gov
serious	Drug Overdose	Injury, poisoning and procedural complications	Citicoline	0	32	0	ClinicalTrials.gov
serious	Drug Overdose	Injury, poisoning and procedural complications	Placebo	1	28	1	ClinicalTrials.gov
serious	Drug Overdose / Suicidal Gesture	Psychiatric disorders	Citicoline	0	32	0	ClinicalTrials.gov
serious	Drug Overdose / Suicidal Gesture	Psychiatric disorders	Placebo	1	28	1	ClinicalTrials.gov
serious	Car Accident	Injury, poisoning and procedural complications	Citicoline	0	32	0	ClinicalTrials.gov
serious	Car Accident	Injury, poisoning and procedural complications	Placebo	1	28	1	ClinicalTrials.gov
serious	Psychiatric Hospitalization Involuntary	Psychiatric disorders	Citicoline	0	32	0	ClinicalTrials.gov
serious	Psychiatric Hospitalization Involuntary	Psychiatric disorders	Placebo	1	28	1	ClinicalTrials.gov

Adverse event totals 6

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Citicoline			ClinicalTrials.gov
Total, all-cause mortality	Placebo			ClinicalTrials.gov
Total, other adverse events	Citicoline	2	32	ClinicalTrials.gov
Total, other adverse events	Placebo	0	28	ClinicalTrials.gov
Total, serious adverse events	Citicoline	1	32	ClinicalTrials.gov
Total, serious adverse events	Placebo	4	28	ClinicalTrials.gov

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source

Grants 0

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Citicoline vs Placebo: serious adverse events	Trial comparisons

Tests 2

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	Source
Stroop Color-Word Test	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)