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An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00823199
First Posted: January 15, 2009
Last Update Posted: August 10, 2015
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.
Information provided by (Responsible Party):
Nigel Bark MD, Bronx Psychiatric Center
  Purpose
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 Intervention
Schizophrenia Drug: Allopurinal

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Nigel Bark MD, Bronx Psychiatric Center:

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


Enrollment: 10
Study Start Date: November 2005
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Allopurinal treatment
Allopurinal 300mg once daily by mouth for four weeks
Drug: Allopurinal
300mg once daily by mouth for four weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
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
Principal Investigator: Nigel Bark, MD Bronx Psychiatric Center
  More Information

Responsible Party: Nigel Bark MD, Director Schizophrenia Research, 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 10, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs