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

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00892021
First received: May 1, 2009
Last updated: July 17, 2009
Last verified: July 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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: May 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NSA-789
Active study drug
Drug: NSA-789
Placebo Comparator: Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Rockville, Maryland, United States, 20850
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: NCT00892021     History of Changes
Other Study ID Numbers: 3230A1-1003
Study First Received: May 1, 2009
Last Updated: July 17, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014