Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia

May 6, 2012 updated by: Sheba Medical Center
The objective of the study is to evaluate the efficacy of allopurinol, compared to placebo, as add-on to anti-psychotics in the treatment of patients with schizophrenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An emerging body of evidence supports a purinergic hypothesis for schizophrenia. Adenosine agonists have been shown to have properties similar to those of dopamine antagonists and there is a well characterized antagonistic interaction between adenosine and dopamine receptors in the ventral striatum1. Increased adenosinergic transmission has been demonstrated to reduce the affinity of dopamine agonists for dopamine receptors. It has been theorized that adenosine may exert some of its antipsychotic effects through modulation of glutamatergic transmission.

Three double-blind, randomized, placebo-controlled trials have showed statistically significant greater improvements in PANSS scores in the allopurinol groups vs. placebo groups. These empiric data, together with the theoretical and basic science background cited, provide the impetus for this proposed study.

Study Type

Interventional

Enrollment (Actual)

248

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Bat Yam, Israel, 59436
        • Abrabanel Mental Health Center
      • Beer-Yaakov, Israel, 70350
        • Beer-Yaakov Mental Health Center
      • Hod Hasharon, Israel
        • Shalvata Mental Health Center
      • Jaffa, Israel, 66849
        • Jaffa Mental House Center
      • Jerusalem, Israel, 91351
        • Herzog Medical Center, Psychiatry
      • Jerusalem, Israel
        • Kfar Shaul Mental Health Center
      • Nes Ziona, Israel
        • Nes Ziona Mental Health Center
      • Shaar Menashe, Israel, 38814
        • Shaar Menashe Mental Health Center
      • Tel Hashomer, Ramat Gan, Israel
        • Sheba Medical Center, Psychiatry Department
      • Zur-Moshe, Israel
        • Lev Hasharon Mental Health Center
  • Romania
      • Bd. Iosif Bulbuca, 156, jud timis, Romania
        • Spitalul Clinic de Urgenta Clinica "E. Pamfil" Timisoara
      • Berceni st., 10-12, Bucharest, Romania, 041902
        • Spitalul Clinic de Psihiatrie, sectia 14
      • Berceni st., 10-12, sector 4, Bucharest, Romania, 041902
        • Spitalul Clinic de Psihiatrie, Clinica 9
      • Berceni st., 10-12, sector 4, Bucharest, Romania, 041902
        • Spitalul Clinic de Psihiatrie, sectia 10
      • Berceni st., 10-12, sector 4, Bucharest, Romania, 041902
        • Spitalul Clinic de Psihiatrie, sectia 12
      • Berceni st., 10-12, sector 4, Bucharest, Romania, 041902
        • Spitalul clinic de Psihiatrie, sectia 13
      • Berceni st., 10-12, sector 4, Bucharest, Romania, 041902
        • Spitalul Clinic de Psihiatrie, sectia 1
      • Berceni st., 10-12, sector 4, Bucharest, Romania, 041902
        • Spitalul Clinic de Psihiatrie, sectia 3
      • Berceni st., 10-12, sector 4, Bucharest, Romania, 041902
        • Spitalul Clinic de Psihiatrie, sectia 6
      • Berceni st., sector 4 Bucharest, Romania, 041902
        • Spitalul Clinic, sectia 8
      • Bld Nicolae Grigorescu, no. 41, Sector 3,, Romania
        • Spitalul de Psihiatrie, Titan
      • Bucuresti, Mircea Vulcanescu 88, Str. Vulcanescu, Nr. 88, Romania
        • Spitalul Clinic de Urgenta Militar Sectia Psihiatrie Clinica
      • Cuza Voda st, 36, Oradea, Romania, 410097
        • Spitalul de Neuropsihiatrie Oradea
      • Gh. Marinescu st.38 ,Targu-Mures, Romania, 540139
        • Clinica de Psihiatrie nr.1
      • Octavian Goga st, 17, Arad, Romania, 310022
        • Spitalul Clinic Judetean de Urgenta, Clinica Psihiatrie
      • Sos Bucium, 36, Iasi, Romania, 700282
        • Spitalul Clinic de Psihiatrie "Socola"
      • Sos. Stefan Cel Mare Nr. 19-21, sect. 2, Romania
        • Spitalul Clinic Colentina Cabinet Psihiatrie Ambulatoriu
      • Str. Bagdazar 12, Sibiu, Romania, 550245
        • Spitalul Clinic de Psihiatrie "Ghe. Preda"
      • Str. Clinicilor nr. 3-5, 3400, Romania
        • Spitalul Clinic Judetean de Urgenta -Cluj
      • Str. I.C.Bratianu Nr. 116, Botosani, Romania
        • Spitalul de Psihiatrie Botosani
      • Str. Prundului 7 - 9, Brasov, Romania, 500123
        • Spitalul Clinic de Psihiatrie si Neurologie
      • Str. Victor Babes, nr. 43, Cluj Napoca, Romania, 400012
        • Spitalul Clinic Judetean, Sectia Clinica Psihiatrie
      • Str.Mihai Eminescu, Nr.18, Brasov, Romania, 500079
        • Spitalul de Psihiatrie si Neurologie

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, 18-65 years of age, inclusive
  2. Because gout is relatively rare in women of childbearing age, there are few reports describing the use of allopurinol during pregnancy; in those there were no adverse fetal outcomes attributable to allopurinol. Therefore, only females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]) can be included in the trial.
  3. Willing and able to provide informed consent, after the nature of the study has been fully explained
  4. Current DSM-IV-TR diagnosis of schizophrenia as confirmed by SCID
  5. Symptoms: 4 (moderate) or above on CGI-S AND >= 4 (moderate) score on two of the following four PANSS items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution.
  6. Must be on any antipsychotic drug for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria. Patients receiving higher doses will have their records reviewed to insure that dose is required. Patients receiving two anti-psychotics, or IM depot antipsychotics can also be included.
  7. Inpatients or outpatients.

Exclusion Criteria:

  1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions
  2. Pregnant or breast-feeding
  3. Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, , kidney disease, impaired liver functioning
  4. Likely allergy or sensitivity to allopurinol
  5. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
  6. Suffers from a significant Substance Dependence disorder based on DSM-IV criteria within the 3 months prior to Screening, or is deemed by the Investigator to have a high risk of substance use during the study. Patients with a history of recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
  7. Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Allopurinol
Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.
Other Names:
  • Alloril, Zylol, Zyloric
Experimental: Allopurinol
Drug: Allopurinol
Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.
Other Names:
  • Alloril, Zylol, Zyloric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PANSS total score.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
PANSS positive, negative and general psychopathology scales, BACS, CGI, Simpson-Angus Scale.
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

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

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Mark Weiser, MD, Sheba Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 18, 2009

First Posted (Estimate)

March 19, 2009

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 6, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-09-6893-MW-CTIL

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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