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

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ClinicalTrials.gov Identifier: NCT02930005
Recruitment Status : Completed
First Posted : October 11, 2016
Results First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston

Study Description
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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.

Condition or disease Intervention/treatment Phase
Psychotic Disorders Schizophrenia Schizoaffective Disorder Bipolar Disorder Drug: Meclofenamic acid Drug: Pentosan polysulfate sodium Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Open-label Trial of Pentosan Polysulfate Sodium and Meclofenamic Acid As Adjunctive Treatments in Patients With Psychotic Disorders
Study Start Date : August 7, 2015
Actual Primary Completion Date : October 6, 2016
Actual Study Completion Date : October 6, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Meclofenamic acid
150mg meclofenamic acid daily for 8 weeks
 Drug: Meclofenamic acid
Other Name: Meclomen
Experimental: Pentosan polysulfate sodium
300mg of pentosan polysulfate sodium daily for 8 weeks
 Drug: Pentosan polysulfate sodium
Other Names:
  • Elmiron
  • Hemoclar
  • Fibrase
  • Anarthron


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02930005


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
More Information
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Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02930005    
Other Study ID Numbers: HSC-MS-15-0329
First Posted: October 11, 2016    Key Record Dates
Results First Posted: March 26, 2019
Last Update Posted: March 26, 2019
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The University of Texas Health Science Center, Houston:
Psychotic
Schizophrenia
Schizoaffective
Bipolar
Additional relevant MeSH terms:
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Disease
Schizophrenia
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Meclofenamic Acid
Pentosan Sulfuric Polyester
Anticoagulants
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action