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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00892021
• Other study ID #: 3230A1-1003
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2009
• Est. completion date: October 2009

Study information

• Verified date: July 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• NSA-789

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results)		6 months
Secondary	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.		6 months