SchizophreniaPhase 4NCT00864825
Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia
A Phase 4 study testing Allopurinol in people with Schizophrenia and Schizoaffective Disorder, run by Sheba Medical Center at 33 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Allopurinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Aug 2009to Jan 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
Romania23 sites
Spitalul Clinic de Urgenta Clinica "E. Pamfil" Timisoara
Bd. Iosif Bulbuca, 156, Jud Timis
Spitalul Clinic de Psihiatrie, sectia 14
Berceni St., 10-12, Bucharest, 041902
Spitalul Clinic de Psihiatrie, Clinica 9
Berceni St., 10-12, Sector 4, Bucharest, 041902
Spitalul Clinic de Psihiatrie, sectia 10
Berceni St., 10-12, Sector 4, Bucharest, 041902
Spitalul Clinic de Psihiatrie, sectia 12
Berceni St., 10-12, Sector 4, Bucharest, 041902
Spitalul clinic de Psihiatrie, sectia 13
Berceni St., 10-12, Sector 4, Bucharest, 041902
Spitalul Clinic de Psihiatrie, sectia 1
Berceni St., 10-12, Sector 4, Bucharest, 041902
Spitalul Clinic de Psihiatrie, sectia 3
Berceni St., 10-12, Sector 4, Bucharest, 041902
Spitalul Clinic de Psihiatrie, sectia 6
Berceni St., 10-12, Sector 4, Bucharest, 041902
Spitalul Clinic, sectia 8
Berceni St., Sector 4 Bucharest, 041902
Spitalul de Psihiatrie, Titan
Bld Nicolae Grigorescu, No. 41, Sector 3,
Spitalul Clinic de Urgenta Militar Sectia Psihiatrie Clinica
Bucuresti, Mircea Vulcanescu 88, Str. Vulcanescu, Nr. 88
Spitalul de Neuropsihiatrie Oradea
Cuza Voda St, 36, Oradea, 410097
Clinica de Psihiatrie nr.1
Gh. Marinescu St.38 ,Targu-Mures, 540139
Spitalul Clinic Judetean De Urgenta, Clinica Psihiatrie
Octavian Goga St, 17, Arad, 310022
Spitalul Clinic de Psihiatrie "Socola"
Sos Bucium, 36, Iasi, 700282
Spitalul Clinic Colentina Cabinet Psihiatrie Ambulatoriu
Sos. Stefan Cel Mare Nr. 19-21, Sect. 2
Spitalul Clinic de Psihiatrie "Ghe. Preda"
Str. Bagdazar 12, Sibiu, 550245
Spitalul Clinic Judetean de Urgenta -Cluj
Str. Clinicilor Nr. 3-5, 3400
Spitalul de Psihiatrie Botosani
Str. I.C.Bratianu Nr. 116, Botosani
Spitalul Clinic de Psihiatrie si Neurologie
Str. Prundului 7 - 9, Brasov, 500123
Spitalul Clinic Judetean, Sectia Clinica Psihiatrie
Str. Victor Babes, Nr. 43, Cluj Napoca, 400012
Spitalul de Psihiatrie si Neurologie
Str.Mihai Eminescu, Nr.18, Brasov, 500079
Israel10 sites
Abrabanel Mental Health Center
Bat Yam, 59436
Beer-Yaakov Mental Health Center
Beer-Yaakov, 70350
Shalvata Mental Health Center
Hod HaSharon
Jaffa Mental House Center
Jaffa, 66849
Herzog Medical Center, Psychiatry
Jerusalem, 91351
Kfar Shaul Mental Health Center
Jerusalem
Nes Ziona Mental Health Center
Ness Ziona
Shaar Menashe Mental Health Center
Shaar Menashe, 38814
Sheba Medical Center, Psychiatry Department
Tel Hashomer, Ramat Gan
Lev Hasharon Mental Health Center
Tsur Moshe
About this study
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.
Read the 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Allopurinol
- Keywords
- Schizophrenia, Allopurinol, Add-on-treatment
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AllopurinolDrug
Also called Alloril, Zylol, Zyloric
Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.
| Study group | Role | What they receive |
|---|---|---|
| Allopurinol | Experimental | Not described Receives: Drug: Allopurinol |
| Placebo | Placebo comparator | Not described Receives: Drug: Allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS total score.
Measured: 6 weeks
Secondary outcomes (1)
PANSS positive, negative and general psychopathology scales, BACS, CGI, Simpson-Angus Scale.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mark Weiser, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864825
- Sponsor's protocol ID
- SHEBA-09-6893-MW-CTIL
- Status last verified
- May 2012
- First submitted
- 17 Mar 2009
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22483162
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allopurinol in Schizophrenia: A Randomized Trial Administering Allopurinol vs Placebo as add-on Antipsychotics in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00864825
- Acronym / sponsor ID
- SHEBA-09-6893-MW-CTIL
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Allopurinol, Add-on-treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allopurinol | Experimental | Drug: Allopurinol |
| Placebo | Placebo comparator | Drug: Allopurinol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AllopurinolAlso: Alloril, Zylol, ZyloricAllopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days. | Drug | Allopurinol, Placebo |
Primary outcome
PANSS total score.
Time frame: 6 weeks
1 secondary outcome
PANSS positive, negative and general psychopathology scales, BACS, CGI, Simpson-Angus Scale.
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2012.
- Derived from this study: PubMed 22483162Weiser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Weiser, MD principal investigator
Sheba Medical Center
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Allopurinol in people with Schizophrenia and Schizoaffective Disorder, run by Sheba Medical Center at 33 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Romania, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS total score. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00864825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2012.