An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

A study testing Allopurinal in people with Schizophrenia, run by Bronx Psychiatric Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a four week open label trial of ALLOPURINOL to the treatment regime of ten (10) poorly responsive patients with schizophrenia, monitoring their response and side-effects. No change in medication is required. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia
What is being tested?: Allopurinal
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: No sites listed yet
Study dates: Nov 2005to Aug 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Subjects with schizophrenia and poor response (no prospect of discharge because of symptoms)

Who cannot join

Over 65
Renal or liver disease
Diabetes
Hypertension
Taking thiazides or ACE inhibitors

About this study

Conditions: Schizophrenia
Being tested: Allopurinal
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AllopurinalDrug
300mg once daily by mouth for four weeks

Study groups in NCT00823199
Study group	Role	What they receive
Allopurinal treatment	Experimental	Allopurinal 300mg once daily by mouth for four weeks Receives: Drug: Allopurinal

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia
Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)
Measured: baseline and 4 weeks

Secondary outcomes (1)

Simpson Angus Scale for Parkinsonism
Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)
Measured: baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Aug 2008

First posted15 Jan 2009 (estimated)
Study startNov 2005
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00823199
Sponsor's protocol ID: ICFV12/02
Status last verified: Jul 2018
First submitted: 14 Jan 2009
Last updated: 21 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia
ClinicalTrials.gov ID: NCT00823199
Acronym / sponsor ID: ICFV12/02
Conditions: Schizophrenia
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Bronx Psychiatric CenterOther government
Study start: Nov 2005
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 15 Jan 2009 (estimated)
Results: Posted 3 May 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Allopurinal treatment	Experimental	Drug: AllopurinalAllopurinal 300mg once daily by mouth for four weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Subjects with schizophrenia and poor response (no prospect of discharge because of symptoms)

Key exclusion criteria (5 listed)

Over 65
Renal or liver disease
Diabetes
Hypertension
Taking thiazides or ACE inhibitors

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
Allopurinal300mg once daily by mouth for four weeks	Drug	Allopurinal treatment

Primary outcome

Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia
Time frame: baseline and 4 weeks
Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)

1 secondary outcome

Simpson Angus Scale for Parkinsonism
Time frame: baseline and 4 weeks

Results and safety

Results posted to the registry on 3 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allopurinal Treatment	10	8

Primary outcome: Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia

Time frame: baseline and 4 weeks. Mean (Standard Deviation). Unit: scores on a scale

Measure	Allopurinal Treatment n = 8
Baseline	95 (22)
End	75 (17)

Population analysed: Two subjects withdrew before the first week's evaluation

1 secondary outcome is reported in the full results.

Adverse events

Time frame: During the 4 week study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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.

Nigel Bark, MD principal investigator

Bronx Psychiatric Center

Questions about this trial

What is this clinical trial studying?

A study testing Allopurinal in people with Schizophrenia, run by Bronx Psychiatric Center.

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 1 inclusion and 5 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 21 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia (time frame: baseline and 4 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 NCT00823199.

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 21 Aug 2018.