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

The University of Texas System (UT)

Status and phase: Completed; Phase 2

Conditions: Psychotic Disorders; Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Drug: Meclofenamic acid; Drug: Pentosan polysulfate sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT02930005

HSC-MS-15-0329

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Meclofenamic acid

Experimental group

Description:

150mg meclofenamic acid daily for 8 weeks

Treatment:

Drug: Meclofenamic acid

Pentosan polysulfate sodium

Experimental group

Description:

300mg of pentosan polysulfate sodium daily for 8 weeks

Treatment:

Drug: Pentosan polysulfate sodium