Phase 2 Completed N=8 Randomized Treatment

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

Psychotic disorders · Schizophrenia · schizoaffective disorder · Bipolar Disorder

Source: ClinicalTrials.gov NCT02930005 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2019

Primary outcomePrimary: Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score — 31.96; 0.96 score

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score	31.96; 0.96	—
SECONDARY Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)	-11; -22	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02930005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.