Trial Outcomes & Findings for A Pilot Study of Citicoline add-on Therapy in Patients With Bipolar Disorder or Major Depressive Disorder and Amphetamine Abuse or Dependence (NCT NCT00377299)

Last Updated: 2013-08-08

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

12 weeks

Results posted on

2013-08-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Citicoline 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 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.
Overall Study STARTED	32	28
Overall Study COMPLETED	13	4
Overall Study NOT COMPLETED	19	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Citicoline 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 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.
Overall Study Lost to Follow-up	14	19
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	5	4

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Citicoline n=32 Participants Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.	Placebo n=28 Participants	Total n=60 Participants Total of all reporting groups
Age Continuous	41.0 years STANDARD_DEVIATION 9.6 • n=93 Participants	34.0 years STANDARD_DEVIATION 7.4 • n=4 Participants	37.8 years STANDARD_DEVIATION 9.3 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	11 Participants n=4 Participants	28 Participants n=27 Participants
Sex: Female, Male Male	15 Participants n=93 Participants	17 Participants n=4 Participants	32 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants	20 Participants n=4 Participants	48 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Region of Enrollment United States	32 participants n=93 Participants	28 participants n=4 Participants	60 participants n=27 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	Citicoline n=28 Participants Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.	Placebo n=20 Participants Placebo.
Depression Symptoms	26.2 scores on a scale Standard Error 2.5	33.1 scores on a scale Standard Error 3.0

SECONDARY outcome

Timeframe: 12 Weeks

Population: ITT includes those returning for at least one post baseline visit. LOCF used for end point data.

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).

Outcome measures

Outcome measures
Measure	Citicoline n=19 Participants Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.	Placebo n=27 Participants Placebo.
Amphetamine Craving	31.9 scores on a scale Standard Error 8.0	44.1 scores on a scale Standard Error 9.7

SECONDARY outcome

Timeframe: 12 weeks

Population: ITT includes those returning for at least one post baseline visit. LOCF used for end point data.

Participant reported days per 7-day week of methamphetamine use.

Outcome measures

Outcome measures
Measure	Citicoline n=28 Participants Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.	Placebo n=20 Participants Placebo.
Amphetamine Use	2.9 days per week Standard Error 0.6	2.3 days per week Standard Error 0.5

SECONDARY outcome

Timeframe: 12 weeks

Population: ITT includes those returning for at least one post baseline visit. LOCF used for end point data.

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.

Outcome measures

Outcome measures
Measure	Citicoline n=17 Participants Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.	Placebo n=9 Participants Placebo.
Hopkins Auditory Verbal Learning Test (HVLT)	38.5 T score Standard Error 3.8	47.5 T score Standard Error 4.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Citicoline n=28 Participants Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.	Placebo n=20 Participants Placebo.
Stroop Color Word Test	56.2 T score Standard Error 2.6	54.3 T score Standard Error 3.1

Adverse Events

Citicoline

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Citicoline n=32 participants at risk Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.	Placebo n=28 participants at risk
Injury, poisoning and procedural complications Injuries Due to Car Accident	3.1% 1/32 • Number of events 1	0.00% 0/28
Injury, poisoning and procedural complications Drug Overdose	0.00% 0/32	3.6% 1/28 • Number of events 1
Psychiatric disorders Drug Overdose / Suicidal Gesture	0.00% 0/32	3.6% 1/28 • Number of events 1
Injury, poisoning and procedural complications Car Accident	0.00% 0/32	3.6% 1/28 • Number of events 1
Psychiatric disorders Psychiatric Hospitalization Involuntary	0.00% 0/32	3.6% 1/28 • Number of events 1

Other adverse events

Other adverse events
Measure	Citicoline n=32 participants at risk Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.	Placebo n=28 participants at risk
Psychiatric disorders Severe Panic Attack	3.1% 1/32 • Number of events 1	0.00% 0/28
Infections and infestations Tooth Abscess and Infection	3.1% 1/32 • Number of events 1	0.00% 0/28

Additional Information

Dr. E. Sherwood Brown, M.D., Ph.D.

UT Southwestern Medical Center at Dallas

Phone: 214-645-6950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place