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Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients

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ClinicalTrials.gov Identifier: NCT00781794
Recruitment Status : Terminated
First Posted : October 29, 2008
Last Update Posted : July 22, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Drug: NSA-789 at 2 different doses Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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
Study Start Date : January 2009
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Dose 1
Drug: NSA-789 at 2 different doses
Experimental: 2
Dose 2
Drug: NSA-789 at 2 different doses
Placebo Comparator: 3 Drug: NSA-789 at 2 different doses

Outcome Measures

Primary Outcome Measures :
  1. electroencephalogram [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. blood sample [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781794

United States, California
Glendale, California, United States, 91206
Rouffach, France, 68250
Toul, France, 54201
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00781794     History of Changes
Other Study ID Numbers: 3230A1-1005
First Posted: October 29, 2008    Key Record Dates
Last Update Posted: July 22, 2009
Last Verified: July 2009

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders