Trial Outcomes & Findings for An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia (NCT NCT00823199)

NCT ID: NCT00823199

Last Updated: 2018-08-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 10 participants
• Primary outcome timeframe: baseline and 4 weeks
• Results posted on: 2018-08-21

Participant Flow

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

Participant milestones

Measure	Allopurinal Treatment
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Allopurinal Treatment
Overall Study Withdrawal by Subject	2

Baseline Characteristics

An Open Trial of Allopurinol in Patients With Poorly Responsive Schizophrenia

Baseline characteristics by cohort

Measure	Group 1 n=10 Participants All participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	38 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 4 weeks

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

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

Outcome measures

Measure	Allopurinal Treatment n=8 Participants
Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia Baseline	95 scores on a scale Standard Deviation 22
Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia End	75 scores on a scale Standard Deviation 17

SECONDARY outcome

Timeframe: baseline and 4 weeks

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

Outcome measures

Measure	Allopurinal Treatment n=8 Participants
Simpson Angus Scale for Parkinsonism Baseline	0.37 score on scale Standard Deviation 0.74
Simpson Angus Scale for Parkinsonism End	1.75 score on scale Standard Deviation 3.1

POST_HOC outcome

Timeframe: Baseline and 4 weeks

Population: 2 subjects had missing data

Outcome measures

Measure	Allopurinal Treatment n=6 Participants
Uric Acid Level Baseline	5.9 mg/dL Standard Deviation 1.7
Uric Acid Level End	3.8 mg/dL Standard Deviation 0.7

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nigel Bark MD

Bronx Psychiatric Center

Phone: 7188625429

Email: Nigel.Bark@omh.ny.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place