NCT00139906

Brief Summary

This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_2 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2005

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

January 16, 2015

Status Verified

March 1, 2006

Enrollment Period

1.2 years

First QC Date

August 30, 2005

Last Update Submit

January 15, 2015

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

Titration StudySchizophreniaBID dosingPharmacokinetic

Interventions

BifeprunoxDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder
  • Body weight of 100-250 lbs
  • Male or females
  • years of age

You may not qualify if:

  • Subjects who are acutely psychotic
  • Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Site 1

National City, California, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

bifeprunox

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Global Clinical Director Solvay

    Solvay Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2005

First Posted

August 31, 2005

Study Start

August 1, 2005

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

January 16, 2015

Record last verified: 2006-03

Locations

US(1)