Trial Outcomes & Findings for Salsalate for Insulin Resistance in Schizophrenia (NCT NCT01182727)

NCT ID: NCT01182727

Last Updated: 2022-03-11

Results Overview

This Measure is reporting the number of participants with side effects as reported on the Side Effect Checklist used to monitor common medication side effects.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: 6 weeks
• Results posted on: 2022-03-11

Participant Flow

Participants were recruited from August 2010 to August 2011 from multiple community mental health clinics.

Participants were withdrawn from the trial if they had abnormal lab values or were found to have a diagnosis of diabetes.

Participant milestones

Measure	Salsalate Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Salsalate for Insulin Resistance in Schizophrenia

Baseline characteristics by cohort

Measure	Salsalate n=10 Participants Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	46.9 years STANDARD_DEVIATION 7.4 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: All subjects who completed the study were analyzed.

This Measure is reporting the number of participants with side effects as reported on the Side Effect Checklist used to monitor common medication side effects.

Outcome measures

Measure	Salsalate n=10 Participants Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
Side Effects of Salsalate	3 participants

Adverse Events

Salsalate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Buchanan, M.D.

Maryland Psychiatric Research Center

Phone: 410-402-7876

Email: rwbuchanan@mprc.umaryland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place