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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.
 
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 Description
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Brief Summary:
This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10) poorly responsive patients with schizophrenia, monitoring their response and side-effects. No change in medication is required.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Allopurinal Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia
Study Start Date : November 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Allopurinal treatment
Allopurinal 300mg once daily by mouth for four weeks
 Drug: Allopurinal
300mg once daily by mouth for four weeks


Outcome Measures
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Primary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia [ Time Frame: baseline and 4 weeks ]
    Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)


Secondary Outcome Measures :
  1. Simpson Angus Scale for Parkinsonism [ Time Frame: baseline and 4 weeks ]
    Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with schizophrenia and poor response (no prospect of discharge because of symptoms)

Exclusion Criteria:

  • Over 65
  • Renal or liver disease
  • Diabetes
  • Hypertension
  • Taking thiazides or ACE inhibitors
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00823199


Sponsors and Collaborators
Bronx Psychiatric Center
Investigators
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Principal Investigator: Nigel Bark, MD Bronx Psychiatric Center
More Information
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Responsible Party: Nigel Bark MD, Director Schizophrenia Research, Bronx Psychiatric Center
ClinicalTrials.gov Identifier: NCT00823199    
Other Study ID Numbers: ICFV12/02
First Posted: January 15, 2009    Key Record Dates
Results First Posted: May 3, 2013
Last Update Posted: August 21, 2018
Last Verified: July 2018
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders