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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00781794 |
The purpose of this study is to evaluate the effect of single doses of NSA-789 on the P50 component of the auditory evoked potentials and to assess the safety, tolerability and the concentration of NSA-789 in the blood, in nonsmoking patients with schizophrenia.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: NSA-789 at 2 different doses |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Pharmacodynamics Study |
Official Title: | A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effects of Single Oral Doses of NSA-789 on Auditory P50 Suppression in Nonsmoking Patients With Stabilized Schizophrenia |
Estimated Enrollment: | 30 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Dose 1
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Drug: NSA-789 at 2 different doses |
2: Experimental
Dose 2
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Drug: NSA-789 at 2 different doses |
3: Placebo Comparator | Drug: NSA-789 at 2 different doses |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
United States, California | |
Recruiting | |
Glendale, California, United States, 91206 | |
France | |
Not yet recruiting | |
Toul, France, 54201 | |
Not yet recruiting | |
Rouffach, France, 68250 |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3230A1-1005 |
Study First Received: | October 28, 2008 |
Last Updated: | May 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00781794 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Institutional Ethical Committee |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features |