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Completed

NCT Number: NCT02930005

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

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.

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Key information

Conditions

Psychotic Disorders Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Schizoaffective Disorder Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meclofenamic acid

Drug

Other names: Meclomen

Pentosan polysulfate sodium

Drug

Other names: Elmiron, Hemoclar, Fibrase, Anarthron

Primary outcomes

  1. Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score

    Time frame: 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 outcomes

  1. Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 11, 2016
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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