Study Evaluating The Effects Of Single Oral Doses Of NSA-789 On Auditory P50 Suppression In Schizophrenic Patients
This study has been terminated.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00781794
First received: October 28, 2008
Last updated: July 21, 2009
Last verified: July 2009
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
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 |
|---|---|
|
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 |
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
Locations
| United States, California | |
| Glendale, California, United States, 91206 | |
| France | |
| Rouffach, France, 68250 | |
| Toul, France, 54201 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer |
More Information
No publications provided
| Responsible Party: | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth |
| ClinicalTrials.gov Identifier: | NCT00781794 History of Changes |
| Other Study ID Numbers: | 3230A1-1005 |
| Study First Received: | October 28, 2008 |
| Last Updated: | July 21, 2009 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013