Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
|ClinicalTrials.gov Identifier: NCT01578486|
Recruitment Status : Completed
First Posted : April 17, 2012
Last Update Posted : January 14, 2016
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|
The specific aims include:
- 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.
- Examine salsalate's effects on Hemoglobin A1c (HbA1c), fasting glucose, insulin and lipids.
- Examine salsalate's effects on high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Salsalate as an Adjunctive Treatment for Patients With Schizophrenia|
|Study Start Date :||June 2011|
|Primary Completion Date :||July 2015|
|Study Completion Date :||July 2015|
open-label trial of salsalate 3g/day
open-label trial of salsalate 3g/day for 12 weeks.
- PANSS Total Score [ Time Frame: 12 weeks ]Positive and negative symptoms of schizophrenia will be measured by total score on Positive and Negative Syndrome Scale (PANSS).
- SANS Total Score [ Time Frame: 12 weeks ]Negative symptoms of schizophrenia will be measure by total score on the Scale for Assessment of Negative Symptoms (SANS)
- MATRICS Total Score [ Time Frame: 12 weeks ]Improved cognition will be measured using the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment
- HbA1c [ Time Frame: 12 weeks ]Hemoglobin A1c (HbA1c) will be used to measure glucose levels. HbA1c will be measured as a percentage.
- Fasting Glucose [ Time Frame: 12 weeks ]Fasting Blood Sugar levels will be measured
- Fasting Insulin [ Time Frame: 12 weeks ]Fasting insulin levels will be measured by uUnits/ml.
- Lipid Profile [ Time Frame: 12 weeks ]Total cholesterol, HDL cholesterol, LDL cholesterol, and triglyceride levels will be measured.
- hs-CRP [ Time Frame: 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.
- TNF-alpha [ Time Frame: 12 weeks ]Tumor necrosis-alpha factor will be measured to assess inflammation levels.
- IL-6 [ Time Frame: 12 weeks ]Interleukin-6 levels will be measured to detect inflammation
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578486
|United States, Massachusetts|
|University of Massaschusetts Medical School|
|Worcester, Massachusetts, United States, 01605|
|Principal Investigator:||Xiaoduo Fan, MD, MPH, MS||UMass Medical School|
|Study Director:||Matthew R Goodnow, BS||UMass Medical School|