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Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients
This study is currently recruiting participants.
Verified by Wyeth, May 2009
First Received: October 28, 2008   Last Updated: May 7, 2009   History of Changes
Sponsored by: Wyeth
Information provided by: Wyeth
ClinicalTrials.gov Identifier: NCT00781794
  Purpose

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

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
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

Further study details as provided by Wyeth:

Primary Outcome Measures:
  • electroencephalogram [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood sample [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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
Drug: NSA-789 at 2 different doses
2: Experimental
Dose 2
Drug: NSA-789 at 2 different doses
3: Placebo Comparator Drug: NSA-789 at 2 different doses

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Women of nonchildbearing potential, or men, aged 18 to 55 years inclusive on study day 1. Women of nonchildbearing potential may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥1 year (with a follicle-stimulating hormone [FSH] level of ≥38 mIU/mL). Women who are surgically sterile must provide documentation of the procedure by an operative report or ultrasound scan. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after test article administration.
  • Body mass index in the range of 18 to 32 kg/m2 and body weight ≥50 kg.
  • Hemoglobin no lower than 0.4 g/dL, less than the lower limit of the normal range, and white blood cell count no lower than 0.5 103/mm3, less than the lower limit of the of the normal range at screening and day -1. Hematocrit and absolute neutrophil count within normal range at screening and on day
  • 1.

Exclusion criteria:

  • Women of childbearing potential.
  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any unstable psychiatric condition, which may prevent the successful and safe completion of the study in the opinion of the investigator.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781794

Contacts
Contact: Trial Manager clintrialparticipation@wyeth.com

Locations
United States, California
Recruiting
Glendale, California, United States, 91206
France
Not yet recruiting
Toul, France, 54201
Not yet recruiting
Rouffach, France, 68250
Sponsors and Collaborators
Wyeth
Investigators
Study Director: Medical Monitor Wyeth
  More Information

No publications provided

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

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009