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

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Allopurinol
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Allopurinol, Add-on-treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Abrabanel Mental Health Center
  • Beer-Yaakov Mental Health Center
  • Shalvata Mental Health Center
  • Jaffa Mental House Center
  • Herzog Medical Center, Psychiatry
  • Kfar Shaul Mental Health Center
  • Nes Ziona Mental Health Center
  • Shaar Menashe Mental Health Center
  • Sheba Medical Center, Psychiatry Department
  • Lev Hasharon Mental Health Center
  • Spitalul Clinic de Urgenta Clinica "E. Pamfil" Timisoara
  • Spitalul Clinic de Psihiatrie, sectia 14
  • Spitalul Clinic de Psihiatrie, Clinica 9
  • Spitalul Clinic de Psihiatrie, sectia 10
  • Spitalul Clinic de Psihiatrie, sectia 12
  • Spitalul clinic de Psihiatrie, sectia 13
  • Spitalul Clinic de Psihiatrie, sectia 1
  • Spitalul Clinic de Psihiatrie, sectia 3
  • Spitalul Clinic de Psihiatrie, sectia 6
  • Spitalul Clinic, sectia 8
  • Spitalul de Psihiatrie, Titan
  • Spitalul Clinic de Urgenta Militar Sectia Psihiatrie Clinica
  • Spitalul de Neuropsihiatrie Oradea
  • Clinica de Psihiatrie nr.1
  • Spitalul Clinic Judetean De Urgenta, Clinica Psihiatrie
  • Spitalul Clinic de Psihiatrie "Socola"
  • Spitalul Clinic Colentina Cabinet Psihiatrie Ambulatoriu
  • Spitalul Clinic de Psihiatrie "Ghe. Preda"
  • Spitalul Clinic Judetean de Urgenta -Cluj
  • Spitalul de Psihiatrie Botosani
  • Spitalul Clinic de Psihiatrie si Neurologie
  • Spitalul Clinic Judetean, Sectia Clinica Psihiatrie
  • Spitalul de Psihiatrie si Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Allopurinol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

PANSS total score.

Secondary Outcome Measures

PANSS positive, negative and general psychopathology scales, BACS, CGI, Simpson-Angus Scale.

Full Information

First Posted
March 17, 2009
Last Updated
May 6, 2012
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00864825
Brief Title
Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia
Official Title
Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Allopurinol, Add-on-treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allopurinol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Allopurinol
Other Intervention Name(s)
Alloril, Zylol, Zyloric
Intervention Description
Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.
Primary Outcome Measure Information:
Title
PANSS total score.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
PANSS positive, negative and general psychopathology scales, BACS, CGI, Simpson-Angus Scale.
Time Frame
6 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: Male or female, 18-65 years of age, inclusive 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. Willing and able to provide informed consent, after the nature of the study has been fully explained Current DSM-IV-TR diagnosis of schizophrenia as confirmed by SCID 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. 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. Inpatients or outpatients. Exclusion Criteria: Unwilling or unable, in the opinion of the Investigator, to comply with study instructions Pregnant or breast-feeding Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, , kidney disease, impaired liver functioning Likely allergy or sensitivity to allopurinol At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others. 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. Concurrent delirium, mental retardation, drug-induced psychosis, or history of brain trauma.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Weiser, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abrabanel Mental Health Center
City
Bat Yam
ZIP/Postal Code
59436
Country
Israel
Facility Name
Beer-Yaakov Mental Health Center
City
Beer-Yaakov
ZIP/Postal Code
70350
Country
Israel
Facility Name
Shalvata Mental Health Center
City
Hod Hasharon
Country
Israel
Facility Name
Jaffa Mental House Center
City
Jaffa
ZIP/Postal Code
66849
Country
Israel
Facility Name
Herzog Medical Center, Psychiatry
City
Jerusalem
ZIP/Postal Code
91351
Country
Israel
Facility Name
Kfar Shaul Mental Health Center
City
Jerusalem
Country
Israel
Facility Name
Nes Ziona Mental Health Center
City
Nes Ziona
Country
Israel
Facility Name
Shaar Menashe Mental Health Center
City
Shaar Menashe
ZIP/Postal Code
38814
Country
Israel
Facility Name
Sheba Medical Center, Psychiatry Department
City
Tel Hashomer, Ramat Gan
Country
Israel
Facility Name
Lev Hasharon Mental Health Center
City
Zur-Moshe
Country
Israel
Facility Name
Spitalul Clinic de Urgenta Clinica "E. Pamfil" Timisoara
City
Bd. Iosif Bulbuca, 156, jud timis
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie, sectia 14
City
Berceni st., 10-12, Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie, Clinica 9
City
Berceni st., 10-12, sector 4, Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie, sectia 10
City
Berceni st., 10-12, sector 4, Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie, sectia 12
City
Berceni st., 10-12, sector 4, Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul clinic de Psihiatrie, sectia 13
City
Berceni st., 10-12, sector 4, Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie, sectia 1
City
Berceni st., 10-12, sector 4, Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie, sectia 3
City
Berceni st., 10-12, sector 4, Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie, sectia 6
City
Berceni st., 10-12, sector 4, Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul Clinic, sectia 8
City
Berceni st., sector 4 Bucharest
ZIP/Postal Code
041902
Country
Romania
Facility Name
Spitalul de Psihiatrie, Titan
City
Bld Nicolae Grigorescu, no. 41, Sector 3,
Country
Romania
Facility Name
Spitalul Clinic de Urgenta Militar Sectia Psihiatrie Clinica
City
Bucuresti, Mircea Vulcanescu 88, Str. Vulcanescu, Nr. 88
Country
Romania
Facility Name
Spitalul de Neuropsihiatrie Oradea
City
Cuza Voda st, 36, Oradea
ZIP/Postal Code
410097
Country
Romania
Facility Name
Clinica de Psihiatrie nr.1
City
Gh. Marinescu st.38 ,Targu-Mures
ZIP/Postal Code
540139
Country
Romania
Facility Name
Spitalul Clinic Judetean De Urgenta, Clinica Psihiatrie
City
Octavian Goga st, 17, Arad
ZIP/Postal Code
310022
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Socola"
City
Sos Bucium, 36, Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
Spitalul Clinic Colentina Cabinet Psihiatrie Ambulatoriu
City
Sos. Stefan Cel Mare Nr. 19-21, sect. 2
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie "Ghe. Preda"
City
Str. Bagdazar 12, Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta -Cluj
City
Str. Clinicilor nr. 3-5, 3400
Country
Romania
Facility Name
Spitalul de Psihiatrie Botosani
City
Str. I.C.Bratianu Nr. 116, Botosani
Country
Romania
Facility Name
Spitalul Clinic de Psihiatrie si Neurologie
City
Str. Prundului 7 - 9, Brasov
ZIP/Postal Code
500123
Country
Romania
Facility Name
Spitalul Clinic Judetean, Sectia Clinica Psihiatrie
City
Str. Victor Babes, nr. 43, Cluj Napoca
ZIP/Postal Code
400012
Country
Romania
Facility Name
Spitalul de Psihiatrie si Neurologie
City
Str.Mihai Eminescu, Nr.18, Brasov
ZIP/Postal Code
500079
Country
Romania

12. IPD Sharing Statement

Citations:
PubMed Identifier
22483162
Citation
Weiser M, Gershon AA, Rubinstein K, Petcu C, Ladea M, Sima D, Podea D, Keefe RS, Davis JM. A randomized controlled trial of allopurinol vs. placebo added on to antipsychotics in patients with schizophrenia or schizoaffective disorder. Schizophr Res. 2012 Jun;138(1):35-8. doi: 10.1016/j.schres.2012.02.014. Epub 2012 Apr 4.
Results Reference
derived

Learn more about this trial

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

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