Phase 4
Completed N=70
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
Source: ClinicalTrials.gov NCT02417142 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score — 33.1; 34.1; 34.1; 32.8 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score |
33.1; 34.1; 34.1; 32.8; 35.8; 34.5 | — |
| SECONDARY Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score |
26.9; 24.7; 27.3; 27.2; 28.4; 28.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02417142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.