Status:
COMPLETED
Effects of RG1068 (Secretin) on Information Processing in Schizophrenia
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Shekhar, Anantha M.D., Ph.D.
Repligen Corporation
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 individ...
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 improv...
Eligibility Criteria
Inclusion
- Able to give informed consent
- DSM-IV diagnosis of schizophrenia
- 18-55 years of age
- Stable medication \> 4 weeks
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00235274
Start Date
November 1 2005
End Date
August 1 2006
Last Update
March 3 2017
Active Locations (1)
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1
LaRue Carter Hospital
Indianapolis, Indiana, United States, 46202