Effects of RG1068 (Secretin) on Information Processing in Schizophrenia
2 other identifiers
interventional
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 schizophrenia
Started Nov 2005
Shorter than P25 for phase_2 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2005
CompletedFirst Posted
Study publicly available on registry
October 10, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedMarch 3, 2017
March 1, 2017
October 6, 2005
March 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Able to give informed consent
- DSM-IV diagnosis of schizophrenia
- years of age
- Stable medication \> 4 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana University School of Medicinelead
- Shekhar, Anantha M.D., Ph.D.collaborator
- Repligen Corporationcollaborator
Study Sites (1)
LaRue Carter Hospital
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anantha Shekhar, MD, PhD
Indiana University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 6, 2005
First Posted
October 10, 2005
Study Start
November 1, 2005
Study Completion
August 1, 2006
Last Updated
March 3, 2017
Record last verified: 2017-03