Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

NCT01578486 | Completed Phase 4 Results

• 1 other identifier: 2011-P-000798
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 12-week, open-label trial of salsalate 3 g/day as an adjunctive treatment in 15 schizophrenia subjects to examine salsalate's effect on psychopathology, cognitive functioning, and metabolic parameters. Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. A total of 15 subjects will be enrolled.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Schizophrenia; Cognition; Metabolism; Antipsychotics; Psychopathology

Outcome Measures

Primary Outcomes (5)

• PANSS Total Score

  Positive and negative symptoms of schizophrenia will be measured by total score on all subscales of the Positive and Negative Syndrome Scale (PANSS; score range 30-210). Higher scores correspond with worse outcomes.

  Baseline and 12 weeks

• SANS Total Score

  Negative symptoms of schizophrenia will be measured by total score on the Scale for Assessment of Negative Symptoms (SANS; score range 0-100). Higher scores correspond with worse outcomes.

  Baseline, 12 weeks

• MATRICS Composite Score

  Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment. The MATRICS assessment includes a battery of tests, and the composite t-score measures cognition across 7 domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. A higher score indicates better cognition.

  Baseline, 12 weeks

• PANSS Positive Score

  Subscale of Positive and Negative Syndrome Scale that specifically measures positive symptoms. The scores range from 7-49, with higher scores representing a worse outcome.

  Baseline, 12 weeks

• PANSS- Negative Score

  Subscale of Positive and Negative Syndrome Scale that specifically measures negative symptoms. The scores range from 7-49, with higher scores representing a worse outcome.

  Baseline, 12 weeks

Secondary Outcomes (3)

• Hs-CRP

  Baseline, 12 weeks

• TNF-alpha

  Baseline,12 weeks

• IL-6

  Baseline, week 12

Study Arms (1)

salsalate

EXPERIMENTAL

open-label trial of salsalate 3g/day

Drug: salsalate

Interventions

salsalate DRUG

open-label trial of salsalate 3g/day for 12 weeks.

salsalate

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years;
• Diagnosis of schizophrenia or schizoaffective disorder;
• Stable dose of the current antipsychotic drug for at least one month;
• Well established compliance with outpatient treatment per treating clinician's judgment;
• Able to complete the cognitive assessment battery (must be English speaking);
• Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study.

You may not qualify if:

• Inability to provide informed consent;
• Current substance abuse;
• Psychiatrically unstable per treating clinician's judgment;
• Significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases;
• Currently on immunosuppressant medication including oral steroids;
• Use of anti-coagulants (heparin, LMWH, warfarin, cilostazol, clopidogrel, dabigatran);
• History of chronic infection (including, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition;
• Experienced asthma, urticaria or allergic type reaction after taking aspirin, salsalate, or other NSAIDS;
• Pregnancy or breastfeeding;
• Pre-existing chronic tinnitus.
• Known hypersensitivity to salsalate.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Massaschusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

salicylsalicylic acid

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Xiaoduo Fan, MD, MPH
• Organization: UMass Medical School

xiaoduo.fan@umassmed.edu

508-856-3881

Study Officials

• Xiaoduo Fan, MD, MPH, MS

  UMass Medical School

  PRINCIPAL INVESTIGATOR

• Matthew R Goodnow, BS

  UMass Medical School

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 17, 2012
• Study Start: June 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 8, 2018
• Results First Posted: May 8, 2018

Record last verified: 2018-04

Locations

US (1)