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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
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Bronx Psychiatric Center:

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: No ]
    Symptom scale Score 30 (best) to 210 (worst)


Secondary Outcome Measures:
  • Simpson Angus Scale for Parkinsonism [ Time Frame: baseline to 4 weeks ] [ Designated as safety issue: Yes ]
    Measures drug induced parkinsonism, score 0 (best) 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: Allopurianal treatment
Allopurinal 300mg once daily by mouth for four weeks
 Drug: Allopurinal
300mg once daily by mouth for four weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00823199

Sponsors and Collaborators
Bronx Psychiatric Center
Investigators
Principal Investigator: Nigel Bark, MD Bronx Psychiatric Center
  More Information

No publications provided

Responsible Party: Nigel Bark MD, Director Schizophrenia Research, 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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Allopurinol
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gout Suppressants
 Antirheumatic Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Antimetabolites
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013