Trial Outcomes & Findings for Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia (NCT NCT00509067)

Last Updated: 2018-04-11

Results Overview

The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

43 participants

Primary outcome timeframe

Measured at Baseline and Weeks 4, 8, 12, and 16

Results posted on

2018-04-11

Participant Flow

Participant milestones

Participant milestones
Measure	Galantamine/CDP Choline Participants assigned to receive galantamine and CDP-choline	Placebos for Galantamine/CDP Choline Participants assigned to receive placebo
Overall Study STARTED	19	24
Overall Study COMPLETED	15	19
Overall Study NOT COMPLETED	4	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Galantamine/CDP Choline Participants assigned to receive galantamine and CDP-choline	Placebos for Galantamine/CDP Choline Participants assigned to receive placebo
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	3	1
Overall Study Protocol Violation	0	3

Baseline Characteristics

Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Galantamine/CDP Choline n=19 Participants Participants assigned to receive galantamine and CDP-choline	Placebos for Galantamine/CDP Choline n=24 Participants Participants assigned to receive placebo	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=93 Participants	22 Participants n=4 Participants	41 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Age, Continuous	54.37 years STANDARD_DEVIATION 8.50 • n=93 Participants	52.38 years STANDARD_DEVIATION 11.04 • n=4 Participants	53.28 years STANDARD_DEVIATION 9.94 • n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	22 Participants n=4 Participants	39 Participants n=27 Participants
Region of Enrollment United States	19 participants n=93 Participants	24 participants n=4 Participants	43 participants n=27 Participants

PRIMARY outcome

Timeframe: Measured at Baseline and Weeks 4, 8, 12, and 16

Population: intent to treat

Outcome measures

Outcome measures
Measure	Galantamine/CDP Choline n=19 Participants Participants assigned to receive galantamine and CDP-choline	Placebos for Galantamine/CDP Choline n=24 Participants Participants assigned to receive placebo
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS) Baseline	17.63 units on a scale Standard Deviation 3.48	18.29 units on a scale Standard Deviation 4.52
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS) Week 4	17.06 units on a scale Standard Deviation 5.6	17.08 units on a scale Standard Deviation 5.64
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS) Week 8	13.93 units on a scale Standard Deviation 5.09	17.26 units on a scale Standard Deviation 5.8
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS) Week 12	14.93 units on a scale Standard Deviation 5.2	17.32 units on a scale Standard Deviation 5.21
Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS) Week 16	13.93 units on a scale Standard Deviation 5.2	16.05 units on a scale Standard Deviation 5.97

SECONDARY outcome

Timeframe: Measured at Baseline and Weeks 4, 8, 12, and 16

Population: intent to treat

The score for each subject was the mean rating on the severity item. The score of the item ranged from 1 (normal) to 7 (among most severely ill).

Outcome measures

Outcome measures
Measure	Galantamine/CDP Choline n=19 Participants Participants assigned to receive galantamine and CDP-choline	Placebos for Galantamine/CDP Choline n=24 Participants Participants assigned to receive placebo
Clinical Global Impression Week 16	3.8 units on a scale Standard Deviation .68	3.68 units on a scale Standard Deviation .67
Clinical Global Impression Baseline	4.32 units on a scale Standard Deviation .48	4.38 units on a scale Standard Deviation .58
Clinical Global Impression Week 4	4 units on a scale Standard Deviation .49	3.92 units on a scale Standard Deviation .65
Clinical Global Impression Week 8	3.67 units on a scale Standard Deviation .62	4.04 units on a scale Standard Deviation .82
Clinical Global Impression Week 12	3.87 units on a scale Standard Deviation .64	4 units on a scale Standard Deviation .82

SECONDARY outcome

Timeframe: Measured at Baseline and Weeks 8 and 16

Population: intent to treat

The measure of verbal learning and memory is the Hopkins Verbal Learning Test. The score for each subject is the sum of the total number of words recalled correctly for Trials 1, 2, and 3. The measure is the mean of these scores at baseline, Week 8, and Week 16.

Outcome measures

Outcome measures
Measure	Galantamine/CDP Choline n=19 Participants Participants assigned to receive galantamine and CDP-choline	Placebos for Galantamine/CDP Choline n=24 Participants Participants assigned to receive placebo
MATRICS Verbal Learning and Memory Baseline	20.5 raw scores Standard Deviation 5.1	20.6 raw scores Standard Deviation 5.8
MATRICS Verbal Learning and Memory Week 8	21.8 raw scores Standard Deviation 4.6	21.2 raw scores Standard Deviation 5.9
MATRICS Verbal Learning and Memory Week 16	23.0 raw scores Standard Deviation 4.7	20.4 raw scores Standard Deviation 5.4

Adverse Events

Galantamine/CDP Choline

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebos for Galantamine/CDP Choline

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Galantamine/CDP Choline n=19 participants at risk Participants assigned to receive galantamine and CDP-choline	Placebos for Galantamine/CDP Choline n=24 participants at risk Participants assigned to receive placebo
Cardiac disorders hospitalized for cardiac symptoms	0.00% 0/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	4.2% 1/24 • Number of events 1 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.

Other adverse events

Additional Information

Dr. Stephen I. Deutsch

Department of Psychiatry Georgetown University Medical School

Phone: 757.446.5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Galantamine/CDP Choline n=19 participants at risk Participants assigned to receive galantamine and CDP-choline	Placebos for Galantamine/CDP Choline n=24 participants at risk Participants assigned to receive placebo
Gastrointestinal disorders Abdominal Pain	31.6% 6/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	12.5% 3/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Drowsiness	31.6% 6/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	12.5% 3/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Headache	26.3% 5/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	20.8% 5/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Malaise	26.3% 5/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	8.3% 2/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Restlessness	26.3% 5/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	8.3% 2/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Dry Mouth	21.1% 4/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	16.7% 4/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
Gastrointestinal disorders Indigestion	21.1% 4/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	4.2% 1/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
Gastrointestinal disorders Nausea	21.1% 4/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	12.5% 3/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Sleep problem	21.1% 4/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	12.5% 3/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Excess Salivation	15.8% 3/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	16.7% 4/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Insomnia	15.8% 3/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	8.3% 2/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Nasal Congestion	15.8% 3/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	16.7% 4/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Sweating	15.8% 3/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	20.8% 5/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
Cardiac disorders Syncope	15.8% 3/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	8.3% 2/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
Gastrointestinal disorders Decrease in Appetite	10.5% 2/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	8.3% 2/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
Gastrointestinal disorders Diarrhea	10.5% 2/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	16.7% 4/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
General disorders Fever	10.5% 2/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	4.2% 1/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.
Gastrointestinal disorders Vomiting	10.5% 2/19 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.	16.7% 4/24 • Adverse events were collected weekly over 16 weeks for each participant. Table presents adverse events by group that were at least moderate at any time point. All AEs were assessed (systematic assessment) on a scale from 1 = absent to 4 = severe.