Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235274
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2005-10-06
Brief Title:
Effects of RG1068 Secretin on Information Processing in Schizophrenia
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Effects of RG1068 Secretin on Information Processing in Schizophrenia
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overarching purpose of the proposed study is to determine Secretins 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
Detailed Description:
In a recent placebo-controlled double-blind multicenter study of Secretin in refractory schizophrenics we found that a patient who received Secretin 10 gkg intravenously showed a marked improvement in eye blink conditioning following infusion This subject also showed a clinical improvement of 20 on the Total Score and Total Negative Score of the Positive and Negative Syndrome Scale PANSS Therefore the primary objective of this study is to confirm and extend this observation in a larger group of individuals with schizophrenia In this 24 to 48 hour experiment the acquisition and extinction of the conditioned blink response will be assessed in participants with schizophrenia who are randomly assigned to one of two double blind treatment groups 1 subcutaneous saline or 2 subcutaneous Secretin 20 ugkg Enrolled participants will remain on their stable medication regime ie psychotropic medications and related treatments will not be manipulated Furthermore given evidence that Secretin administration increases the amygdalas activation during experimental presentation of fear-related facial cue stimuli we wish to also investigate the effects of the experimental agent on psychophysiological processes putatively related to amygdala function Prepulse inhibition is a widely studied paradigm in the schizophrenia literature thought to reflect disruption of early sensory-motor gating that is present in both individuals with schizophrenia and their unaffected biological relatives and can be mediated by various limbic structures including the amygdala 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 our laboratory and are currently approved for our use by the IRBs at both IUPUI and IUB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 4587049 | None | None | None |