Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Conditions
Keywords
Psychotic, Schizophrenia, Schizoaffective, Bipolar
Brief summary
This study evaluates the feasibility of administering meclofenamic acid or pentosan polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic disorder. Half of participants will receive meclofenamic acid, while the other half will receive polysulfate sodium.
Detailed description
Chronic, low-grade brain inflammation is involved in the development of schizophrenia and other psychotic disorders. Medications with anti-inflammatory properties, like meclofenamic acid and pentosan polysulfate may help to reduce brain inflammation and serve as a treatment of psychotic disorders.
Interventions
DRUGMeclofenamic acid
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorders, unspecified schizophrenia spectrum and other psychotic disorders * Negative pregnancy test in females of childbearing age
Exclusion criteria
* Urine drug screen positive for psychostimulants such as cocaine, amphetamines and ecstasy * Any infection, neoplasm, autoimmune disease or other primary inflammatory condition (3) Previous diagnosis of intellectual disability or dementia * Current treatment with heparin * Use of or allergy to non-steroidal anti-inflammatory agent or pentosan polysulfate sodium * Current or anticipated corticosteroid use * History of peptic ulcer disease, gastro esophageal reflux disease, or gastrointestinal bleeding * Those on warfarin or any anticoagulant * Current treatment with lithium or asthma medication * Individuals with pre-existing liver, cardiac, or kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score | baseline, 8 weeks | A higher composite score on the NCTB indicates better cognitive performance. The NCTB consists of 7 tests and 8 sub-scores, and the NIH Toolbox software calculates total composite score by averaging the normalized scores of each subscale and then deriving scale scores. The NIH Toolbox Scoring and Interpretation Guide (found online) doesn't indicate a total composite score range (because the score ranges are infinite), but describes scoring as follows: To get a normalized composite score, the score of the test taker is compared to the scores in the NIH Toolbox nationally representative normative sample. The mean score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS) | baseline, 8 weeks | Change in the Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks. The range of scores on the PANSS is 30 to 210, with higher scores associated with better outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Meclofenamic Acid 150mg meclofenamic acid daily for 8 weeks
Meclofenamic acid | 2 |
| Pentosan Polysulfate Sodium 300mg of pentosan polysulfate sodium daily for 8 weeks
Pentosan polysulfate sodium | 6 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 5 |
Baseline characteristics
| Characteristic | Meclofenamic Acid | Total | Pentosan Polysulfate Sodium |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 8 Participants | 6 Participants |
| Age, Continuous | 20.5 years STANDARD_DEVIATION 3.5 | 24.6 years STANDARD_DEVIATION 7.8 | 26 years STANDARD_DEVIATION 8.6 |
| Region of Enrollment United States | 2 Participants | 8 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 6 |
| other Total, other adverse events | 0 / 2 | 1 / 6 |
| serious Total, serious adverse events | 0 / 2 | 0 / 6 |
Outcome results
Primary
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score
A higher composite score on the NCTB indicates better cognitive performance. The NCTB consists of 7 tests and 8 sub-scores, and the NIH Toolbox software calculates total composite score by averaging the normalized scores of each subscale and then deriving scale scores. The NIH Toolbox Scoring and Interpretation Guide (found online) doesn't indicate a total composite score range (because the score ranges are infinite), but describes scoring as follows: To get a normalized composite score, the score of the test taker is compared to the scores in the NIH Toolbox nationally representative normative sample. The mean score is 100 and the standard deviation (SD) is 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.
Time frame: baseline, 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meclofenamic Acid | Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score | 31.96 score |
| Pentosan Polysulfate Sodium | Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score | 0.96 score |
Secondary
Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)
Change in the Positive and Negative Syndrome Scale (PANSS) total score after 8 weeks. The range of scores on the PANSS is 30 to 210, with higher scores associated with better outcomes.
Time frame: baseline, 8 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Meclofenamic Acid | Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS) | -11 score |
| Pentosan Polysulfate Sodium | Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS) | -22 score |