An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00823199
Recruitment Status : Completed
First Posted : January 15, 2009
Results First Posted : May 3, 2013
Last Update Posted : August 10, 2015
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

  Participant Flow

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
Allopurinal Treatment No text entered.

Participant Flow:   Overall Study
    Allopurinal Treatment
Withdrawal by Subject                2 

  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.
No text entered.

Reporting Groups
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   10 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 38  (9.3) 
[Units: Participants]
Female   2 
Male   8 
Region of Enrollment 
[Units: Participants]
United States   10 

  Outcome Measures

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

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

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

  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
No text entered.

  More Information

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

Responsible Party: Nigel Bark MD, Bronx Psychiatric Center 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 10, 2015