Effects of RG1068 (Secretin) on Information Processing in Schizophrenia

• Status: Completed
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Collaborators: Repligen Corporation; Shekhar, Anantha M.D., Ph.D.
• Treatments: Secretin

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