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

Tracking Information

First Received Date ^ICMJE

January 14, 2009

Last Updated Date

March 21, 2013

Start Date ^ICMJE

November 2005

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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)

Original Primary Outcome Measures ^ICMJE

Change in PANSS [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT00823199 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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)

Original Secondary Outcome Measures ^ICMJE

Movement disorder ratings [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

Official Title ^ICMJE

An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Allopurinal

300mg once daily by mouth for four weeks

Study Arm (s)

Experimental: Allopurianal treatment

Allopurinal 300mg once daily by mouth for four weeks

Intervention: Drug: Allopurinal

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00823199

Other Study ID Numbers ^ICMJE

ICFV12/02

Has Data Monitoring Committee

Responsible Party

Nigel Bark MD, Bronx Psychiatric Center

Study Sponsor ^ICMJE

Bronx Psychiatric Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Nigel Bark, MD

Bronx Psychiatric Center

Information Provided By

Bronx Psychiatric Center

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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