SchizophreniaPhase 4NCT01578486

Salsalate as an Adjunctive Treatment for Patients With Schizophrenia

A Phase 4 study testing salsalate in people with Schizophrenia and Schizoaffective Disorder, run by University of Massachusetts, Worcester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: salsalate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 1 siteUnited States
Study dates: Jun 2011to Jul 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Massaschusetts Medical School
Worcester, Massachusetts, 01605

Other trials in United States

About this study

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.

Read the 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:

Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: salsalate
Keywords: Schizophrenia, Cognition, Metabolism, Antipsychotics, Psychopathology
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01578486
Study group	Role	What they receive
salsalate	Experimental	open-label trial of salsalate 3g/day Receives: Drug: salsalate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 12 weeks

Secondary outcomes (3)

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.
Measured: Baseline, 12 weeks
TNF-alpha
Tumor necrosis-alpha factor will be measured to assess inflammation levels.
Measured: Baseline,12 weeks
IL-6
IL-6 (interleukin 6) is a marker used to measure inflammation.
Measured: Baseline, week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2011Jul 2015

First posted17 Apr 2012 (estimated)
Study startJun 2011
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01578486
Sponsor's protocol ID: 2011-P-000798
Status last verified: Apr 2018
First submitted: 11 Apr 2012
Last updated: 8 May 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Salsalate as an Adjunctive Treatment for Patients With Schizophrenia
ClinicalTrials.gov ID: NCT01578486
Acronym / sponsor ID: 2011-P-000798
Conditions: Schizophrenia, Schizoaffective Disorder
Keywords: Schizophrenia, Cognition, Metabolism, Antipsychotics, Psychopathology
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: University of Massachusetts, WorcesterUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: Jun 2011
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 17 Apr 2012 (estimated)
Results: Posted 8 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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:

Examine salsalate's effects on inflammatory markers such as high sensitivity C-reactive protein (hs-CRP), TNF-α and IL-6.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
salsalate	Experimental	Drug: salsalateopen-label trial of salsalate 3g/day

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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);

Key exclusion criteria (11 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
salsalateopen-label trial of salsalate 3g/day for 12 weeks.	Drug	salsalate

Primary outcome

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.
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.
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.
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.
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.

3 secondary outcomes

Hs-CRP
Time frame: Baseline, 12 weeks
TNF-alpha
Time frame: Baseline,12 weeks
IL-6
Time frame: Baseline, week 12

Results and safety

Results posted to the registry on 8 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Salsalate	13	8

Primary outcome: PANSS Total Score

Time frame: Baseline and 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Salsalate n = 8
Baseline	58.2 (11.4)
Week 12	53.5 (11.9)

Primary outcome: SANS Total Score

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Salsalate n = 8
Baseline	33.0 (15.7)
Week 12	33.0 (12.9)

Primary outcome: MATRICS Composite Score

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: t-score

Measure	Salsalate n = 8
Baseline	27.9 (11.9)
Week 12	31.6 (15.2)

Primary outcome: PANSS Positive Score

Time frame: Baseline, 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Salsalate n = 8
Baseline	13.0 (5.4)
Week 12	10.9 (4.4)

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Salsalate	0 of 8 (0%)	7 of 8 (87.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
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Not yet recruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Xiaoduo Fan, MD, MPH, MS principal investigator

UMass Medical School

Matthew R Goodnow, BS study director

UMass Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing salsalate in people with Schizophrenia and Schizoaffective Disorder, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PANSS Total Score (time frame: Baseline and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01578486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.