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

NCT ID: NCT02930005

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-07
• Study Completion Date: 2016-10-06

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.

Conditions

Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Meclofenamic acid

150mg meclofenamic acid daily for 8 weeks

Group Type: EXPERIMENTAL

Meclofenamic acid

Intervention Type: DRUG

Pentosan polysulfate sodium

300mg of pentosan polysulfate sodium daily for 8 weeks

Group Type: EXPERIMENTAL

Pentosan polysulfate sodium

Intervention Type: DRUG

Interventions

Meclofenamic acid

Intervention Type: DRUG

Pentosan polysulfate sodium

Intervention Type: DRUG

Other Intervention Names

Meclomen; Elmiron; Hemoclar; Fibrase; Anarthron

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-15-0329

Identifier Type: -

Identifier Source: org_study_id