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CompletedNCT00823199Updated Aug 21, 2018Results posted

An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

An interventional study of Allopurinal in Schizophrenia, sponsored by Bronx Psychiatric Center. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-21.

Sponsored by Bronx Psychiatric Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 10 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Bronx Psychiatric Center is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Over 65
  • Renal or liver disease
  • Diabetes
  • Hypertension
  • Taking thiazides or ACE inhibitors
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Allopurinal treatment

    Allopurinal 300mg once daily by mouth for four weeks

    Drug: Allopurinal

Interventions

  • DrugAllopurinal

    300mg once daily by mouth for four weeks

06

What researchers measure

Primary outcomes

  1. Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia

    Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)

    Time frame: baseline and 4 weeks

Secondary outcomes

  1. Simpson Angus Scale for Parkinsonism

    Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)

    Time frame: baseline and 4 weeks

07

Results

Posted May 3, 2013

Participant flow

Ten subjects were recruited, in-patients in a State Hospital, between 2005 and 2008

Participant flow — Overall Study
MilestoneAllopurinal Treatment
Started10
Completed8
Not completed2
Withdrew: Withdrawal by subject2

Outcome measures

PrimaryChange in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia

Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst)

Time frame:
baseline and 4 weeks
Reported as:
Mean · scores on a scale
Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia
scores on a scaleAllopurinal Treatment
Baseline95 ± 22
End75 ± 17
SecondarySimpson Angus Scale for Parkinsonism

Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)

Time frame:
baseline and 4 weeks
Reported as:
Mean · score on scale
Simpson Angus Scale for Parkinsonism
score on scaleAllopurinal Treatment
Baseline0.37 ± 0.74
End1.75 ± 3.1
Post-hocUric Acid Level
Time frame:
Baseline and 4 weeks
Reported as:
Mean · mg/dL
Uric Acid Level
mg/dLAllopurinal Treatment
Baseline5.9 ± 1.7
End3.8 ± 0.7

Adverse events

Collected over During the 4 week study. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1—0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group 1
<=18 years0
Between 18 and 65 years10
>=65 years0
Age, Continuous
Age, Continuous(years)Group 1
Mean38 ± 9.3
Sex: Female, Male
Sex: Female, Male(Participants)Group 1
Female2
Male8
Region of Enrollment
Region of Enrollment(participants)Group 1
United States10
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00823199
Lead sponsor
Bronx Psychiatric Center
Responsible party
Nigel Bark MD (Director Schizophrenia Research, Bronx Psychiatric Center) — Principal investigator
First posted
Jan 15, 2009
Start date
Nov 2005
Primary completion
Aug 2008
Completion
Aug 2008
Results posted
May 3, 2013
Last update
Aug 21, 2018

Study contacts

Nigel Bark, MD
principal investigator · Bronx Psychiatric Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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