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

NCT02930005 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: HSC-MS-15-0329
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Keywords

Psychotic; Schizophrenia; Schizoaffective; Bipolar

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 8 weeks

Secondary Outcomes (1)

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

  baseline, 8 weeks

Study Arms (2)

Meclofenamic acid

EXPERIMENTAL

150mg meclofenamic acid daily for 8 weeks

Drug: Meclofenamic acid

Pentosan polysulfate sodium

EXPERIMENTAL

300mg of pentosan polysulfate sodium daily for 8 weeks

Drug: Pentosan polysulfate sodium

Interventions

Meclofenamic acid DRUG

Also known as: Meclomen

Meclofenamic acid

Pentosan polysulfate sodium DRUG

Also known as: Elmiron, Hemoclar, Fibrase, Anarthron

Pentosan polysulfate sodium

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Bipolar Disorder; Mental Disorders

Interventions

Meclofenamic Acid; Pentosan Sulfuric Polyester

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Olaoluwa O. Okusaga
• Organization: The University of Texas Health Science Center at Houston

Olaoluwa.O.Okusaga@uth.tmc.edu

(713) 741-3952

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 11, 2016
• Study Start: August 7, 2015
• Primary Completion: October 6, 2016
• Study Completion: October 6, 2016
• Last Updated: March 26, 2019
• Results First Posted: March 26, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)