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

Phase 1WithdrawnNCT00892021

Wyeth is now a wholly owned subsidiary of Pfizer

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Conditions

Schizophrenia

Interventions

NSA-789DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Rockville, Maryland, United States

Outcomes

Primary Outcomes

Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results)

Time frame: 6 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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