Effects of RG1068 (Secretin) on Information Processing in Schizophrenia - Full Text View

Sponsors and Collaborators:	Indiana University School of Medicine Shekhar, Anantha M.D., Ph.D. Repligen Corporation
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00235274

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: Subcutaneous Secretin	Phase II

MedlinePlus related topics: Schizophrenia

Drug Information available for: Secretin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of RG1068 (Secretin) on Information Processing in Schizophrenia

Further study details as provided by Indiana University:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	30
Study Start Date:	November 2005
Estimated Study Completion Date:	August 2006

Detailed Description:

In a recent placebo-controlled, double-blind, multicenter study of Secretin in refractory schizophrenics, we found that a patient who received Secretin (1.0 g/kg) 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 ug/kg). Enrolled participants will remain on their stable medication regime (i.e., psychotropic medications and related treatments will not be manipulated). Furthermore, given evidence that Secretin administration increases the amygdala’s 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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Able to give informed consent
DSM-IV diagnosis of schizophrenia
18-55 years of age
Stable medication > 4 weeks

Exclusion Criteria:

Active suicidal ideation
Concurrent DSM-IV comorbidity with any substance dependence
A urine drug screen that is qualitatively positive for controlled substances
Abnormal hepatic function (AST or ALT > 2.5 X the upper limit of normal, or bilirubin > 1.5 X the upper limit of normal)
Abnormal renal function (BUN or creatinine > 1.5 X the upper limit of normal)
Abnormal bone marrow function (WBC < 4 x 103/mm3, Platelets <100 x 103/mm3 and hemoglobin <10 g/dl)
Any history of sensitivity to any of the ingredients in the study drug
Clinically significant organic disease including cardiovascular, hepatic, pulmonary, neurologic, or renal disease or other medical condition, serious intercurrent illness, or extenuating circumstances that, in the opinion of the Investigator, would interfere with the performance or interpretability of, or put the patient at risk from, the study procedures.
Women who are pregnant, breastfeeding, or refuse to use adequate birth control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235274

Locations

United States, Indiana
LaRue Carter Hospital
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University School of Medicine

Shekhar, Anantha M.D., Ph.D.

Repligen Corporation

Investigators

Principal Investigator:

Anantha Shekhar, MD, PhD

Indiana University School of Medicine

More Information

Study ID Numbers:	0507-30, 4587049
Study First Received:	October 6, 2005
Last Updated:	July 18, 2006
ClinicalTrials.gov Identifier:	NCT00235274
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Indiana University:

Schizophrenia
Secretin

Study placed in the following topic categories:

Schizophrenia
Secretin
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Gastrointestinal Agents
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009