Study Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder

This study is not yet open for participant recruitment.

Verified by Wyeth, May 2009

First Received: May 1, 2009 No Changes Posted

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00892021

Purpose

This study will evaluate the safety of multiple doses of NSA-789 in subjects with schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is absorbed and eliminated, and its effect, if any, on the brain.

Condition	Intervention	Phase
Schizophrenia	Drug: NSA-789 Drug: Placebo	Phase I

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Parallel Assignment, Safety Study
Official Title:	An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NSA-789 Administered Orally to Subjects With Schizophrenia or Schizoaffective Disorder

Further study details as provided by Wyeth:

Primary Outcome Measures:

Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Tolerability as measured through the reporting of adverse events; Pharmacokinetic as measured by the concentrations of NSA-789 in blood; Pharmacodynamics as measured by the results of psychiatric ratings and neurologic evaluations. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	June 2009
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
NSA-789: Experimental Active study drug	Drug: NSA-789
Placebo: Placebo Comparator Inactive study drug	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion:

Men or women of non childbearing potential (WONCBP) aged 18 to 50 years, inclusive.
Currently under the care of a physician for psychiatric illness.
Clinical diagnosis of schizophrenia or schizo affective disorder in the opinion of the study psychiatrist based on review of all available clinical data.

Exclusion:

Any unstable medical or psychiatric condition, which may prevent the successful and safe completion of the study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892021

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

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:	3230A1-1003
Study First Received:	May 1, 2009
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00892021 History of Changes
Health Authority:	United States: Food and Drug Administration

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
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009