Back to resultsPentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
Primary Purpose
Psychotic Disorders, Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Meclofenamic acid
Pentosan polysulfate sodium
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring Psychotic, Schizophrenia, Schizoaffective, Bipolar
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
Sites / Locations
- The University of Texas Health Science Center at Houston
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Meclofenamic acid
Pentosan polysulfate sodium
Arm Description
150mg meclofenamic acid daily for 8 weeks
300mg of pentosan polysulfate sodium daily for 8 weeks
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02930005
First Posted
September 28, 2016
Last Updated
March 25, 2019
Sponsor
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT02930005
Brief Title
Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
Official Title
A Pilot Open-label Trial of Pentosan Polysulfate Sodium and Meclofenamic Acid As Adjunctive Treatments in Patients With Psychotic Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 7, 2015 (undefined)
Primary Completion Date
October 6, 2016 (Actual)
Study Completion Date
October 6, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center, Houston
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
Keywords
Psychotic, Schizophrenia, Schizoaffective, Bipolar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Meclofenamic acid
Arm Type
Experimental
Arm Description
150mg meclofenamic acid daily for 8 weeks
Arm Title
Pentosan polysulfate sodium
Arm Type
Experimental
Arm Description
300mg of pentosan polysulfate sodium daily for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Meclofenamic acid
Other Intervention Name(s)
Meclomen
Intervention Type
Drug
Intervention Name(s)
Pentosan polysulfate sodium
Other Intervention Name(s)
Elmiron, Hemoclar, Fibrase, Anarthron
Primary Outcome Measure Information:
Title
Change in Cognitive Function as Assessed by the NIH Toolbox Cognitive Test Battery (NCTB) Composite Score
Description
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
Secondary Outcome Measure Information:
Title
Change in Severity of Psychotic Symptoms as Assessed by Positive and Negative Syndrome Scale (PANSS)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
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