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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

248

participants targeted

Target at P75+ for phase_4 schizophrenia

Timeline

Completed

Started Aug 2009

Shorter than P25 for phase_4 schizophrenia

Geographic Reach

2 countries

33 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

March 17, 2009

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 19, 2009

Completed

5 months until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed

Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

4 months

First QC Date

March 17, 2009

Last Update Submit

May 6, 2012

Conditions

Schizophrenia Schizoaffective Disorder

Keywords

SchizophreniaAllopurinolAdd-on-treatment

Outcome Measures

Primary Outcomes (1)

PANSS total score.
6 weeks

Secondary Outcomes (1)

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

Study Arms (2)

Allopurinol

EXPERIMENTAL

Drug: Allopurinol

Placebo

PLACEBO COMPARATOR

Drug: Allopurinol

Interventions

AllopurinolDRUG

Allopurinol 1 capsule 300 mg, or placebo, bid (twice a day) for 42 days.

Also known as: Alloril, Zylol, Zyloric

AllopurinolPlacebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Sheba Medical Centerlead

Study Sites (33)

Abrabanel Mental Health Center

Bat Yam, 59436, Israel

Location

Beer-Yaakov Mental Health Center

Beer-Yaakov, 70350, Israel

Location

Shalvata Mental Health Center

Hod HaSharon, Israel

Location

Jaffa Mental House Center

Jaffa, 66849, Israel

Location

Herzog Medical Center, Psychiatry

Jerusalem, 91351, Israel

Location

Kfar Shaul Mental Health Center

Jerusalem, Israel

Location

Nes Ziona Mental Health Center

Ness Ziona, Israel

Location

Shaar Menashe Mental Health Center

Shaar Menashe, 38814, Israel

Location

Sheba Medical Center, Psychiatry Department

Tel Hashomer, Ramat Gan, Israel

Location

Lev Hasharon Mental Health Center

Tsur Moshe, Israel

Location

Spitalul Clinic de Urgenta Clinica "E. Pamfil" Timisoara

Bd. Iosif Bulbuca, 156, Jud Timis, Romania

Location

Spitalul Clinic de Psihiatrie, sectia 14

Berceni St., 10-12, Bucharest, 041902, Romania

Location

Spitalul Clinic de Psihiatrie, Clinica 9