Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
Completed · Phase 4 · Has a placebo group
Conditions studied: Schizophrenia, Schizoaffective Disorder
In brief
This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine exenatide's effects on negative symptoms and cognition.
Key facts
- Study ID
- NCT02417142
- Run by
- University of Massachusetts, Worcester
- People needed
- 70
- Starts
- 2014-09-01
- Expected to finish
- 2020-07-01
- Last updated by the study team
- 2022-01-14
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 anti-inflammatory or immunosuppressant medication including oral steroids
- currently on sulfonylurea drugs (e.g. glyburide)
- history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition
- pregnant or breastfeeding
- prisoners
Where it is running
- UMass Medical School — Worcester, Massachusetts, United States
Full record on ClinicalTrials.gov
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