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An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nigel Bark MD, Bronx Psychiatric Center
ClinicalTrials.gov Identifier:
NCT00823199
First received: January 14, 2009
Last updated: March 21, 2013
Last verified: March 2013
Results First Received: April 25, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Allopurinal

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Ten subjects were recruited, in-patients in a State Hospital, between 2005 and 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Allopurinal Treatment No text entered.

Participant Flow:   Overall Study
    Allopurinal Treatment  
STARTED     10  
COMPLETED     8  
NOT COMPLETED     2  
Withdrawal by Subject                 2  



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Group 1 No text entered.

Baseline Measures
    Group 1  
Number of Participants  
[units: participants]
  10  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  38  ± 9.3  
Gender  
[units: participants]
 
Female     2  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia   [ Time Frame: baseline to 4 weeks ]

2.  Secondary:   Simpson Angus Scale for Parkinsonism   [ Time Frame: baseline to 4 weeks ]

3.  Post-Hoc:   Uric Acid Level   [ Time Frame: Baseline to 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Nigel Bark MD
Organization: Bronx Psychiatric Center
phone: 7188625429
e-mail: Nigel.Bark@omh.ny.gov


No publications provided


Responsible Party: Nigel Bark MD, Bronx Psychiatric Center
ClinicalTrials.gov Identifier: NCT00823199     History of Changes
Other Study ID Numbers: ICFV12/02
Study First Received: January 14, 2009
Results First Received: April 25, 2012
Last Updated: March 21, 2013
Health Authority: United States: Institutional Review Board