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Use of Galantamine and CDP-choline (Citicoline) to Treat Adults With Schizophrenia (STAR-1)

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ClinicalTrials.gov Identifier: NCT00509067
Recruitment Status : Completed
First Posted : July 31, 2007
Results First Posted : February 7, 2014
Last Update Posted : April 11, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Washington D.C. Veterans Affairs Medical Center
Information provided by (Responsible Party):
Stephen I. Deutsch, National Institute of Mental Health (NIMH)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Galantamine
Drug: CDP-choline
Drug: Placebo
Drug: risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Galantamine/CDP Choline Placebos for Galantamine/CDP Choline
Hide Arm/Group Description Participants assigned to receive galantamine and CDP-choline Participants assigned to receive placebo
Period Title: Overall Study
Started 19 24
Completed 15 19
Not Completed 4 5
Reason Not Completed
Lost to Follow-up             1             1
Adverse Event             3             1
Protocol Violation             0             3
Arm/Group Title Galantamine/CDP Choline Placebos for Galantamine/CDP Choline Total
Hide Arm/Group Description Participants assigned to receive galantamine and CDP-choline Participants assigned to receive placebo Total of all reporting groups
Overall Number of Baseline Participants 19 24 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 24 participants 43 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
22
  91.7%
41
  95.3%
>=65 years
0
   0.0%
2
   8.3%
2
   4.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 24 participants 43 participants
54.37  (8.50) 52.38  (11.04) 53.28  (9.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 24 participants 43 participants
Female
2
  10.5%
2
   8.3%
4
   9.3%
Male
17
  89.5%
22
  91.7%
39
  90.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 24 participants 43 participants
19 24 43
1.Primary Outcome
Title Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)
Hide Description 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.
Time Frame Measured at Baseline and Weeks 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Galantamine/CDP Choline Placebos for Galantamine/CDP Choline
Hide Arm/Group Description:
Participants assigned to receive galantamine and CDP-choline
Participants assigned to receive placebo
Overall Number of Participants Analyzed 19 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 17.63  (3.48) 18.29  (4.52)
Week 4 17.06  (5.6) 17.08  (5.64)
Week 8 13.93  (5.09) 17.26  (5.8)
Week 12 14.93  (5.2) 17.32  (5.21)
Week 16 13.93  (5.2) 16.05  (5.97)
2.Secondary Outcome
Title Clinical Global Impression
Hide Description 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).
Time Frame Measured at Baseline and Weeks 4, 8, 12, and 16
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Galantamine and CDP-choline Group Placebo Group
Hide Arm/Group Description:

Participants assigned to galantamine and CDP-choline

Galantamine: Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.

CDP-choline: CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.

risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, zipr

Participants assigned to placebo

Placebo: The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.

risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.

Overall Number of Participants Analyzed 19 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 4.32  (.48) 4.38  (.58)
Week 4 4  (.49) 3.92  (.65)
Week 8 3.67  (.62) 4.04  (.82)
Week 12 3.87  (.64) 4  (.82)
Week 16 3.8  (.68) 3.68  (.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galantamine and CDP-choline Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments alpha set at P < .05
Method Mixed Models Analysis
Comments Time (0, 4, 8, 12, 16 wks) x Treatment (Drug, Placebo) Effect: F(1, 33)=0.01.
3.Secondary Outcome
Title MATRICS Verbal Learning and Memory
Hide Description 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.
Time Frame Measured at Baseline and Weeks 8 and 16
Hide Outcome Measure Data
Hide Analysis Population Description
intent to treat
Arm/Group Title Galantamine and CDP-choline Group Placebo Group
Hide Arm/Group Description:

Participants assigned to receive galantamine/CDP-choline

Galantamine: Galantamine will be titrated to 24 mg/day over 2 weeks. Participants will receive 8 mg/day in two divided doses for 1 week, 16 mg/day in two divided doses for 1 week, and 24 mg/day in two divided doses beginning in Week 3. They will be maintained on 24 mg/day for the remainder of the study.

CDP-choline: CDP-choline will serve as the dietary source of choline. CDP-choline will be titrated to 2000 mg/day over 1 week. Subjects will receive 500 mg/day for 3 days; Thereafter, the dose of CDP-choline will be increased to 1,000 mg/day in two divided doses for 4 days. At the beginning of Week 2, participants will receive the maximum fixed dose of 2000 mg/day in two divided doses, which will be held constant through the end of Week 16.

risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, zipr

Participants assigned to receive placebo

Placebo: The schedule of dose titration of placebo galantamine and placebo CDP-choline will follow the schedule of active medication condition using matching placebos for each agent.

risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole: All participants will continue to take their regular regimen of risperidone, olanzapine, quetiapine, ziprasidone, and/or aripiprazole throughout the trial in addition to their assigned treatment.

Overall Number of Participants Analyzed 19 24
Mean (Standard Deviation)
Unit of Measure: raw scores
Baseline 20.5  (5.1) 20.6  (5.8)
Week 8 21.8  (4.6) 21.2  (5.9)
Week 16 23.0  (4.7) 20.4  (5.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Galantamine and CDP-choline Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments alpha level set at .05
Method Mixed Models Analysis
Comments Time (0, 8, 16 weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48..
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Galantamine and CDP-choline Group, Placebo Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.23
Comments alpha set at P<0.05
Method Mixed Models Analysis
Comments Time (0, 8, 16, weeks) x Group (Drug, Placebo) Effect: F(1, 32.8)=1.48.
Time Frame Adverse events were collected weekly over 16 weeks for each participant.
Adverse Event Reporting Description

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.

 
Arm/Group Title Galantamine/CDP Choline Placebos for Galantamine/CDP Choline
Hide Arm/Group Description Participants assigned to receive galantamine and CDP-choline Participants assigned to receive placebo
All-Cause Mortality
Galantamine/CDP Choline Placebos for Galantamine/CDP Choline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Galantamine/CDP Choline Placebos for Galantamine/CDP Choline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      1/24 (4.17%)    
Cardiac disorders     
hospitalized for cardiac symptoms  [1]  0/19 (0.00%)  0 1/24 (4.17%)  1
Indicates events were collected by systematic assessment
[1]
One placebo participant was hospitalized with cardiac symptoms. This SAE resolved.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Galantamine/CDP Choline Placebos for Galantamine/CDP Choline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/19 (52.63%)      14/24 (58.33%)    
Cardiac disorders     
Syncope   3/19 (15.79%)  2/24 (8.33%) 
Gastrointestinal disorders     
Abdominal Pain   6/19 (31.58%)  3/24 (12.50%) 
Indigestion   4/19 (21.05%)  1/24 (4.17%) 
Nausea   4/19 (21.05%)  3/24 (12.50%) 
Decrease in Appetite   2/19 (10.53%)  2/24 (8.33%) 
Diarrhea   2/19 (10.53%)  4/24 (16.67%) 
Vomiting   2/19 (10.53%)  4/24 (16.67%) 
General disorders     
Drowsiness   6/19 (31.58%)  3/24 (12.50%) 
Headache   5/19 (26.32%)  5/24 (20.83%) 
Malaise   5/19 (26.32%)  2/24 (8.33%) 
Restlessness   5/19 (26.32%)  2/24 (8.33%) 
Dry Mouth   4/19 (21.05%)  4/24 (16.67%) 
Sleep problem   4/19 (21.05%)  3/24 (12.50%) 
Excess Salivation   3/19 (15.79%)  4/24 (16.67%) 
Insomnia   3/19 (15.79%)  2/24 (8.33%) 
Nasal Congestion   3/19 (15.79%)  4/24 (16.67%) 
Sweating   3/19 (15.79%)  5/24 (20.83%) 
Fever   2/19 (10.53%)  1/24 (4.17%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Stephen I. Deutsch
Organization: Department of Psychiatry Georgetown University Medical School
Phone: 757.446.5888
Responsible Party: Stephen I. Deutsch, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00509067     History of Changes
Other Study ID Numbers: R34MH077849 ( U.S. NIH Grant/Contract )
R34MH077849 ( U.S. NIH Grant/Contract )
DATR A5-ETBD
First Submitted: July 30, 2007
First Posted: July 31, 2007
Results First Submitted: July 1, 2013
Results First Posted: February 7, 2014
Last Update Posted: April 11, 2018