Back to resultsAn Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Allopurinal
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allopurinal treatment
Arm Description
Allopurinal 300mg once daily by mouth for four weeks
Outcomes
Primary Outcome Measures
Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia
Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)
Secondary Outcome Measures
Simpson Angus Scale for Parkinsonism
Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)
Full Information
NCT ID
NCT00823199
First Posted
January 14, 2009
Last Updated
July 23, 2018
Sponsor
Bronx Psychiatric Center
1. Study Identification
Unique Protocol Identification Number
NCT00823199
Brief Title
An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia
Official Title
An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bronx Psychiatric Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allopurinal treatment
Arm Type
Experimental
Arm Description
Allopurinal 300mg once daily by mouth for four weeks
Intervention Type
Drug
Intervention Name(s)
Allopurinal
Intervention Description
300mg once daily by mouth for four weeks
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia
Description
Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)
Time Frame
baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Simpson Angus Scale for Parkinsonism
Description
Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)
Time Frame
baseline and 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Bark, MD
Organizational Affiliation
Bronx Psychiatric Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia
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