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

Phase 1

Withdrawn

• Conditions: Schizophrenia
• Interventions: Drug: NSA-789; Drug: Placebo

• Registration Number: NCT00892021
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-01
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Status Verified: 2009-07
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2021-08-17
• Last Update Posted: 2021-08-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSA-789	NSA-789	Active study drug
Placebo	Placebo	Inactive study drug

Primary Outcome Measures

Name	Time	Method
Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results)	6 months

Secondary Outcome Measures

Name	Time	Method
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