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

• Sponsor: The University of Texas Health Science Center, Houston (Other)
• Overall Status: Completed
• CT.gov ID: NCT02930005
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Duration (Months): 14
• Patients Per Site Per Month: 0.6

Study Details

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.

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

• Study Type: Interventional
• 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: Aug 7, 2015
• Actual Primary Completion Date: Oct 6, 2016
• Actual Study Completion Date: Oct 6, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Meclofenamic acid 150mg meclofenamic acid daily for 8 weeks	Drug: Meclofenamic acid; Other Names: 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

Primary Outcome Measures

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

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT02930005
• Other Study ID Numbers: HSC-MS-15-0329
• First Posted: Oct 11, 2016
• Last Update Posted: Mar 26, 2019
• Last Verified: Feb 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Disease; Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders; Meclofenamic Acid; Pentosan Sulfuric Polyester

Study Results

Participant Flow

Arm/Group Title	Meclofenamic Acid	Pentosan Polysulfate Sodium
Arm/Group Description	150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
Period Title: Overall Study
STARTED	2	6
Completed 2 Weeks	2	2
COMPLETED	1	1
NOT COMPLETED	1	5

Baseline Characteristics

Arm/Group Title	Meclofenamic Acid	Pentosan Polysulfate Sodium	Total
Arm/Group Description	150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium	Total of all reporting groups
Overall Participants	2	6	8
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	2 100%	6 100%	8 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	20.5 (3.5)	26 (8.6)	24.6 (7.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	2 33.3%	2 25%
Male	2 100%	4 66.7%	6 75%
Region of Enrollment (Count of Participants)
United States	2 100%	6 100%	8 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meclofenamic Acid	Pentosan Polysulfate Sodium
Arm/Group Description	150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
Measure Participants	1	1
Number [score]	31.96	0.96

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Meclofenamic Acid	Pentosan Polysulfate Sodium
Arm/Group Description	150mg meclofenamic acid daily for 8 weeks Meclofenamic acid	300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
Measure Participants	1	1
Number [score]	-11	-22

Adverse Events

Time Frame	up to 8 weeks
Arm/Group Title	Meclofenamic Acid		Pentosan Polysulfate Sodium
Arm/Group Description	150mg meclofenamic acid daily for 8 weeks Meclofenamic acid		300mg of pentosan polysulfate sodium daily for 8 weeks Pentosan polysulfate sodium
All Cause Mortality
	Meclofenamic Acid		Pentosan Polysulfate Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/6 (0%)
Serious Adverse Events
	Meclofenamic Acid		Pentosan Polysulfate Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Meclofenamic Acid		Pentosan Polysulfate Sodium
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/2 (0%)		1/6 (16.7%)
Endocrine disorders
Hyperglycemia	0/2 (0%)	0	1/6 (16.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.