NCT00892021

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Shorter than P25 for phase_1 schizophrenia

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

August 20, 2021

Status Verified

July 1, 2009

Enrollment Period

5 months

First QC Date

May 1, 2009

Last Update Submit

August 17, 2021

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • 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

Study Arms (2)

NSA-789

EXPERIMENTAL

Active study drug

Drug: NSA-789

Placebo

PLACEBO COMPARATOR

Inactive study drug

Drug: Placebo

Interventions

NSA-789DRUG
NSA-789
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Any unstable medical or psychiatric condition, which may prevent the successful and safe completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Rockville, Maryland, 20850, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 4, 2009

Study Start

May 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

August 20, 2021

Record last verified: 2009-07

Locations

US(1)