Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia

What Was Tested

In this phase 4 trial, researchers set out to test Exenatide.

It had two arms (groups): Experimental (experimental) and Placebo (placebo comparator).

Placebo.

The registry classes the interventions as drug.

More on the Plan

The specific aims include: Primary aim: 1\.

Examine exenatide's effect on schizophrenia symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) total score. 2.

Examine exenatide's effect on neuro-protection as measured by the change in hippocampal volume. 4.

Examine exenatide's effects on inflammatory markers including serum levels of high sensitivity C-reactive Protein (CRP), Interleukin 6 (IL-6), and tumor necrosis factor (TNF-α). 5.

Who Took Part

The registry lists 70 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-65 years. Diagnosis of schizophrenia or schizoaffective disorder. Well established compliance with outpatient treatment per treating clinician's judgment. Able to complete the cognitive assessment battery (must be English speaking).

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: inability to provide informed consent; current substance abuse; psychiatrically unstable per treating clinician's judgment.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Exenatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2014-09 with completion listed for 2019-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score (time frame: Baseline, Week 6, Week 12, Week 18 and Week 24).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Exenatide in 70 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page, all human trials.