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Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
salsalate
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cognition, Metabolism, Antipsychotics, Psychopathology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • University of Massaschusetts Medical School

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

salsalate

Arm Description

open-label trial of salsalate 3g/day

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Hs-CRP
High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation. Higher hs-CRP values correspond to higher levels of inflammation.
TNF-alpha
Tumor necrosis-alpha factor will be measured to assess inflammation levels.
IL-6
IL-6 (interleukin 6) is a marker used to measure inflammation.

Full Information

First Posted
April 11, 2012
Last Updated
April 5, 2018
Sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT01578486
Brief Title
Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
Official Title
Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The specific aims include: Primary aims: Examine the efficacy of salsalate (3g/day) in improving positive and negative symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) and the Scale for Assessment of Negative Symptoms (SANS). Examine the efficacy of salsalate in improving cognition as measured by the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) composite score. Secondary aims: 1. Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Schizophrenia, Cognition, Metabolism, Antipsychotics, Psychopathology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
salsalate
Arm Type
Experimental
Arm Description
open-label trial of salsalate 3g/day
Intervention Type
Drug
Intervention Name(s)
salsalate
Intervention Description
open-label trial of salsalate 3g/day for 12 weeks.
Primary Outcome Measure Information:
Title
PANSS Total Score
Description
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.
Time Frame
Baseline and 12 weeks
Title
SANS Total Score
Description
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.
Time Frame
Baseline, 12 weeks
Title
MATRICS Composite Score
Description
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.
Time Frame
Baseline, 12 weeks
Title
PANSS Positive Score
Description
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.
Time Frame
Baseline, 12 weeks
Title
PANSS- Negative Score
Description
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.
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Hs-CRP
Description
High-sensitivity C-reactive protein (hs-CRP) will be measured in mg/L in order to detect inflammation. Higher hs-CRP values correspond to higher levels of inflammation.
Time Frame
Baseline, 12 weeks
Title
TNF-alpha
Description
Tumor necrosis-alpha factor will be measured to assess inflammation levels.
Time Frame
Baseline,12 weeks
Title
IL-6
Description
IL-6 (interleukin 6) is a marker used to measure inflammation.
Time Frame
Baseline, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoduo Fan, MD, MPH, MS
Organizational Affiliation
UMass Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthew R Goodnow, BS
Organizational Affiliation
UMass Medical School
Official's Role
Study Director
Facility Information:
Facility Name
University of Massaschusetts Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States

12. IPD Sharing Statement

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Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

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