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Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01578486
Recruitment Status : Completed
First Posted : April 17, 2012
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Xiaoduo Fan, University of Massachusetts, Worcester

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Drug: salsalate Phase 4

Detailed Description:

The specific aims include:

Primary aims:

  1. 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).
  2. 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
Study Start Date : June 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: salsalate
open-label trial of salsalate 3g/day
Drug: salsalate
open-label trial of salsalate 3g/day for 12 weeks.




Primary Outcome Measures :
  1. PANSS Total Score [ Time Frame: Baseline and 12 weeks ]
    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.

  2. SANS Total Score [ Time Frame: Baseline, 12 weeks ]
    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.

  3. MATRICS Composite Score [ Time Frame: Baseline, 12 weeks ]
    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.

  4. PANSS Positive Score [ Time Frame: Baseline, 12 weeks ]
    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.

  5. PANSS- Negative Score [ Time Frame: Baseline, 12 weeks ]
    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 :
  1. Hs-CRP [ Time Frame: Baseline, 12 weeks ]
    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.

  2. TNF-alpha [ Time Frame: Baseline,12 weeks ]
    Tumor necrosis-alpha factor will be measured to assess inflammation levels.

  3. IL-6 [ Time Frame: Baseline, week 12 ]
    IL-6 (interleukin 6) is a marker used to measure inflammation.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578486


Locations
United States, Massachusetts
University of Massaschusetts Medical School
Worcester, Massachusetts, United States, 01605
Sponsors and Collaborators
University of Massachusetts, Worcester
National Institutes of Health (NIH)
Investigators
Principal Investigator: Xiaoduo Fan, MD, MPH, MS UMass Medical School
Study Director: Matthew R Goodnow, BS UMass Medical School

Responsible Party: Xiaoduo Fan, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01578486     History of Changes
Other Study ID Numbers: 2011-P-000798
First Posted: April 17, 2012    Key Record Dates
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018
Last Verified: April 2018

Keywords provided by Xiaoduo Fan, University of Massachusetts, Worcester:
Schizophrenia
Cognition
Metabolism
Antipsychotics
Psychopathology

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Salicylsalicylic acid
Sodium Salicylate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action