Status:
UNKNOWN
A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients
Lead Sponsor:
Memory Pharmaceuticals
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio. ...
Eligibility Criteria
Inclusion
- 1\. Male or female subjects between 18and 55 years of age.
- 2\. Fluent in English, even if English is not the primary language.
- 3\. Able to provide informed consent.
- 4\. DSM IV-R primary diagnosis of schizophrenia (any subtype), assessed using a structured diagnostic interview (SCID CT).
- 5\. Few or no extra-pyramidal symptoms(EPS)at screening,defined as SAS \< 6.
- 6\. Negative urine drug screen (UDS).
- 7\. Negative cotinine test.
- 8\. Clinically stable, as judged by the investigator, and in a non-acute phase for at least 12 weeks. At least one month on the same dose of antipsychotic medication.
Exclusion
- Current risk of suicide, or history of suicidal behavior within the last 6 months.
- Hospitalized for psychiatric symptoms in the past 3 months.
- Other psychiatric diagnoses.
- Substance abuse/dependence (other than nicotine or caffeine) within the last 6 months according to the SCID-CT.
- Currently smoking, nicotine replacement therapy, smoking cessation medications or remedies, including Varenicline (Chantix).
- Any medical condition, as judged by the Investigator, which may interfere with the subjects' participation in this study.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00725855
Start Date
August 1 2008
End Date
April 1 2009
Last Update
July 31 2008
Active Locations (1)
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1
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262