Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Massachusetts, Worcester
• Collaborator: Stanley Medical Research Institute
• Treatments: Exenatide

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 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