Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Schizoaffective Disorder |
Drug: Allopurinol |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia |
- PANSS total score. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- PANSS positive, negative and general psychopathology scales, BACS, CGI, Simpson-Angus Scale. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 248 |
| Study Start Date: | August 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Allopurinol |
Drug: Allopurinol
Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.
Other Name: Alloril, Zylol, Zyloric
|
| Placebo Comparator: Placebo |
Drug: Allopurinol
Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.
Other Name: Alloril, Zylol, Zyloric
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Israel | |
| Abrabanel Mental Health Center | |
| Bat Yam, Israel, 59436 | |
| Beer-Yaakov Mental Health Center | |
| Beer-Yaakov, Israel, 70350 | |
| Shalvata Mental Health Center | |
| Hod Hasharon, Israel | |
| Jaffa Mental House Center | |
| Jaffa, Israel, 66849 | |
| Herzog Medical Center, Psychiatry | |
| Jerusalem, Israel, 91351 | |
| Kfar Shaul Mental Health Center | |
| Jerusalem, Israel | |
| Nes Ziona Mental Health Center | |
| Nes Ziona, Israel | |
| Shaar Menashe Mental Health Center | |
| Shaar Menashe, Israel, 38814 | |
| Sheba Medical Center, Psychiatry Department | |
| Tel Hashomer, Ramat Gan, Israel | |
| Lev Hasharon Mental Health Center | |
| Zur-Moshe, Israel | |
| Romania | |
| Spitalul Clinic de Urgenta Clinica "E. Pamfil" Timisoara | |
| Bd. Iosif Bulbuca, 156, jud timis, Romania | |
| Spitalul Clinic de Psihiatrie, sectia 14 | |
| Berceni st., 10-12, Bucharest, Romania, 041902 | |
| Spitalul Clinic de Psihiatrie, sectia 10 | |
| 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 6 | |
| 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 12 | |
| 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, Clinica 9 | |
| Berceni st., 10-12, sector 4, Bucharest, Romania, 041902 | |
| Spitalul Clinic, sectia 8 | |
| Berceni st., sector 4 Bucharest, Romania, 041902 | |
| Spitalul de Psihiatrie, Titan | |
| Bld Nicolae Grigorescu, no. 41, Sector 3,, Romania | |
| Spitalul Clinic de Urgenta Militar Sectia Psihiatrie Clinica | |
| Bucuresti, Mircea Vulcanescu 88, Str. Vulcanescu, Nr. 88, Romania | |
| Spitalul de Neuropsihiatrie Oradea | |
| Cuza Voda st, 36, Oradea, Romania, 410097 | |
| Clinica de Psihiatrie nr.1 | |
| Gh. Marinescu st.38 ,Targu-Mures, Romania, 540139 | |
| Spitalul Clinic Judetean De Urgenta, Clinica Psihiatrie | |
| Octavian Goga st, 17, Arad, Romania, 310022 | |
| Spitalul Clinic de Psihiatrie "Socola" | |
| Sos Bucium, 36, Iasi, Romania, 700282 | |
| Spitalul Clinic Colentina Cabinet Psihiatrie Ambulatoriu | |
| Sos. Stefan Cel Mare Nr. 19-21, sect. 2, Romania | |
| Spitalul Clinic de Psihiatrie "Ghe. Preda" | |
| Str. Bagdazar 12, Sibiu, Romania, 550245 | |
| Spitalul Clinic Judetean de Urgenta -Cluj | |
| Str. Clinicilor nr. 3-5, 3400, Romania | |
| Spitalul de Psihiatrie Botosani | |
| Str. I.C.Bratianu Nr. 116, Botosani, Romania | |
| Spitalul Clinic de Psihiatrie si Neurologie | |
| Str. Prundului 7 - 9, Brasov, Romania, 500123 | |
| Spitalul Clinic Judetean, Sectia Clinica Psihiatrie | |
| Str. Victor Babes, nr. 43, Cluj Napoca, Romania, 400012 | |
| Spitalul de Psihiatrie si Neurologie | |
| Str.Mihai Eminescu, Nr.18, Brasov, Romania, 500079 | |
| Principal Investigator: | Mark Weiser, MD | Sheba Medical Center |
More Information
No publications provided by Sheba Medical Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sheba Medical Center |
| ClinicalTrials.gov Identifier: | NCT00864825 History of Changes |
| Other Study ID Numbers: | SHEBA-09-6893-MW-CTIL |
| Study First Received: | March 17, 2009 |
| Last Updated: | May 6, 2012 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Sheba Medical Center:
|
Schizophrenia Allopurinol Add-on-treatment |
Additional relevant MeSH terms:
|
Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Allopurinol Antipsychotic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gout Suppressants Antirheumatic Agents |
Therapeutic Uses Free Radical Scavengers Antioxidants Antimetabolites Protective Agents Physiological Effects of Drugs Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 19, 2013