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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Galantamine/CDP Choline Participants assigned to receive galantamine and CDP-choline
Placebos for Galantamine/CDP Choline Participants assigned to receive placebo

Participant Flow:   Overall Study
    Galantamine/CDP Choline   Placebos for Galantamine/CDP Choline
STARTED   19   24 
COMPLETED   15   19 
NOT COMPLETED   4   5 
Lost to Follow-up                1                1 
Adverse Event                3                1 
Protocol Violation                0                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Galantamine/CDP Choline Participants assigned to receive galantamine and CDP-choline
Placebos for Galantamine/CDP Choline Participants assigned to receive placebo
Total Total of all reporting groups

Baseline Measures
   Galantamine/CDP Choline   Placebos for Galantamine/CDP Choline   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   24   43 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 54.37  (8.50)   52.38  (11.04)   53.28  (9.94) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  10.5%      2   8.3%      4   9.3% 
Male      17  89.5%      22  91.7%      39  90.7% 
Region of Enrollment 
[Units: Participants]
     
United States   19   24   43 


  Outcome Measures

1.  Primary:   Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)   [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ]

2.  Secondary:   Clinical Global Impression   [ Time Frame: Measured at Baseline and Weeks 4, 8, 12, and 16 ]

3.  Secondary:   MATRICS Verbal Learning and Memory   [ Time Frame: Measured at Baseline and Weeks 8 and 16 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: DeutscSI@EVMS.EDU


Publications:

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