An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

July 23, 2018 updated by: Nigel Bark MD, Bronx Psychiatric Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
baseline and 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bronx Psychiatric Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

January 14, 2009

First Submitted That Met QC Criteria

January 14, 2009

First Posted (Estimate)

January 15, 2009

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

July 23, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICFV12/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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