Schizophrenia
Conditions
Brief 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.
Interventions
DRUGAllopurinal
300mg once daily by mouth for four weeks
Sponsors
Bronx Psychiatric Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with schizophrenia and poor response (no prospect of discharge because of symptoms)
Exclusion criteria
* Over 65 * Renal or liver disease * Diabetes * Hypertension * Taking thiazides or ACE inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia | baseline and 4 weeks | Symptom scale Score 30 (best, no symptoms of schizophrenia) to 210 (worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Simpson Angus Scale for Parkinsonism | baseline and 4 weeks | Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst) |
Participant flow
Recruitment details
Ten subjects were recruited, in-patients in a State Hospital, between 2005 and 2008
Participants by arm
| Arm | Count |
|---|---|
| Group 1 All participants | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 38 years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
Population: Two subjects withdrew before the first week's evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allopurinal Treatment | Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia | Baseline | 95 scores on a scale | Standard Deviation 22 |
| Allopurinal Treatment | Change in Positive and Negative Syndrome Scale (PANSS) Measures Symptoms of Schizophrenia | End | 75 scores on a scale | Standard Deviation 17 |
Secondary
Simpson Angus Scale for Parkinsonism
Measures drug induced parkinsonism, score 0 (best, no Parkinsonism) to 36 (worst)
Time frame: baseline and 4 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allopurinal Treatment | Simpson Angus Scale for Parkinsonism | Baseline | 0.37 score on scale | Standard Deviation 0.74 |
| Allopurinal Treatment | Simpson Angus Scale for Parkinsonism | End | 1.75 score on scale | Standard Deviation 3.1 |
Post Hoc
Uric Acid Level
Time frame: Baseline and 4 weeks
Population: 2 subjects had missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Allopurinal Treatment | Uric Acid Level | Baseline | 5.9 mg/dL | Standard Deviation 1.7 |
| Allopurinal Treatment | Uric Acid Level | End | 3.8 mg/dL | Standard Deviation 0.7 |