Effects of RG1068 (Secretin) on Information Processing in Schizophrenia

What Was Tested

In this phase 2 trial, researchers set out to test Secretin.

The overarching purpose of the proposed study is to determine Secretin's (RG1068) psychophysiological effects on measures of motor learning, affective, and inhibitory information processing in individuals with schizophrenia.

Motor learning will be assessed with a classical eye-blink conditioning procedure, requiring the learning of a reflexive eye-blink response to a weak puff of air to the eye.

The registry classes the interventions as drug.

More on the Plan

Therefore, the primary objective of this study is to confirm and extend this observation in a larger group of individuals with schizophrenia.

Enrolled participants will remain on their stable medication regime (i.e., psychotropic medications and related treatments will not be manipulated).

Therefore, as a secondary aim, the effects of Secretin will be tested on affect modulation, pre-pulse inhibition, and pre-pulse facilitation of the acoustic startle response using common psychophysiological research procedures.

These procedures are frequently used in their laboratory and are currently approved for their use by the IRBs at both IUPUI and IUB.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 18 years up to 55 years.

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

Examples of who could join: Able to give informed consent. DSM-IV diagnosis of schizophrenia. 18-55 years of age. Stable medication \> 4 weeks.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: active suicidal ideation; concurrent dsm-iv comorbidity with any substance dependence; A urine drug screen that is qualitatively positive for controlled substances.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Secretin and who got the comparison, which limits bias.

The Secretin 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 Secretin.

It started in 2005-11 with completion listed for 2006-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Motor learning will be assessed with a classical eye-blink conditioning procedure, requiring the learning of a reflexive eye-blink response to a weak puff of air to the eye.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Secretin in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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