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Trial record 67 of 3313 for:    schizophrenia

An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

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ClinicalTrials.gov Identifier: NCT00823199
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : May 3, 2013
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Nigel Bark MD, Bronx Psychiatric Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Allopurinal
Enrollment 10
Recruitment Details Ten subjects were recruited, in-patients in a State Hospital, between 2005 and 2008
Pre-assignment Details  
Arm/Group Title Allopurinal Treatment
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 10
Completed 8
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Group 1
Hide Arm/Group Description All participants
Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants
38  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
2
  20.0%
Male
8
  80.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia
Hide Description Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Two subjects withdrew before the first week's evaluation
Arm/Group Title Allopurinal Treatment
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline 95  (22)
End 75  (17)
2.Secondary Outcome
Title Simpson Angus Scale for Parkinsonism
Hide Description Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)
Time Frame baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allopurinal Treatment
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 8
Mean (Standard Deviation)
Unit of Measure: score on scale
Baseline 0.37  (0.74)
End 1.75  (3.1)
3.Post-Hoc Outcome
Title Uric Acid Level
Hide Description [Not Specified]
Time Frame Baseline and 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
2 subjects had missing data
Arm/Group Title Allopurinal Treatment
Hide Arm/Group Description:
all participants
Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 5.9  (1.7)
End 3.8  (0.7)
Time Frame During the 4 week study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1
Hide Arm/Group Description All participants
All-Cause Mortality
Group 1
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nigel Bark MD
Organization: Bronx Psychiatric Center
Phone: 7188625429
EMail: Nigel.Bark@omh.ny.gov
Layout table for additonal information
Responsible Party: Nigel Bark MD, Bronx Psychiatric Center
ClinicalTrials.gov Identifier: NCT00823199     History of Changes
Other Study ID Numbers: ICFV12/02
First Submitted: January 14, 2009
First Posted: January 15, 2009
Results First Submitted: April 25, 2012
Results First Posted: May 3, 2013
Last Update Posted: August 21, 2018