Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Pilot Open-label Trial of Pentosan Polysulfate Sodium and Meclofenamic Acid As Adjunctive Treatments in Patients With Psychotic Disorders

Conditions
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Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder

Intervention / Treatment
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* Drug: Meclofenamic acid
* Drug: Pentosan polysulfate sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meclofenamic acid<br>150mg meclofenamic acid daily for 8 weeks | Drug: Meclofenamic acid<br> <br> * Other names: Meclomen;|
| Experimental: Pentosan polysulfate sodium<br>300mg of pentosan polysulfate sodium daily for 8 weeks | Drug: Pentosan polysulfate sodium<br> <br> * Other names: Anarthron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotic, Schizophrenia, Schizoaffective, Bipolar