Effects of RG1068 (Secretin) on Information Processing in Schizophrenia

This study has been completed.
Sponsor:
Collaborators:
Shekhar, Anantha M.D., Ph.D.
Repligen Corporation
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00235274
First received: October 6, 2005
Last updated: July 18, 2006
Last verified: July 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of RG1068 (Secretin) on Information Processing in Schizophrenia

Resource links provided by NLM:


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:

  1. Able to give informed consent
  2. DSM-IV diagnosis of schizophrenia
  3. 18-55 years of age
  4. Stable medication > 4 weeks

Exclusion Criteria:

  1. Active suicidal ideation
  2. Concurrent DSM-IV comorbidity with any substance dependence
  3. A urine drug screen that is qualitatively positive for controlled substances
  4. Abnormal hepatic function (AST or ALT > 2.5 X the upper limit of normal, or bilirubin > 1.5 X the upper limit of normal)
  5. Abnormal renal function (BUN or creatinine > 1.5 X the upper limit of normal)
  6. Abnormal bone marrow function (WBC < 4 x 103/mm3, Platelets <100 x 103/mm3 and hemoglobin <10 g/dl)
  7. Any history of sensitivity to any of the ingredients in the study drug
  8. 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.
  9. Women who are pregnant, breastfeeding, or refuse to use adequate birth control
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Keywords provided by Indiana University:
Schizophrenia
Secretin

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Secretin
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014