Back to resultsStudy Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NSA-789
Placebo
Sponsored by
About this trial
This is an interventional other trial for Schizophrenia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NSA-789
Placebo
Arm Description
Active study drug
Inactive study drug
Outcomes
Primary Outcome Measures
Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results)
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.
Full Information
NCT ID
NCT00892021
First Posted
May 1, 2009
Last Updated
August 17, 2021
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00892021
Brief Title
Study Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Withdrawn
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2009 (Anticipated)
Study Completion Date
October 2009 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NSA-789
Arm Type
Experimental
Arm Description
Active study drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Inactive study drug
Intervention Type
Drug
Intervention Name(s)
NSA-789
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Evaluating the Effects of Multiple Doses of NSA-789 in Subjects With Schizophrenia or Schizoaffective Disorder
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