Trials Sponsors Conditions Drugs Pricing

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

The primary analysis will be the change from baseline on body weight at the final evaluation.
8 weeks

Secondary Outcomes (1)

Secondary outcomes include: Change from baseline in triglyceride level, Change from baseline in waist circumference, and Change from baseline in total Positive and Negative Syndrome Scale (PANSS) score.
8 weeks

Study Arms (2)

A

EXPERIMENTAL

Drug: bifeprunox

B

ACTIVE COMPARATOR

Drug: risperidone

Interventions

bifeprunoxDrug

.25mg titrate up to 20mg/day (week 1) then 30mg/day (weeks 2-8)

risperidoneDrug

4mg, QD, 8 week treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Current treatment of at least 3 months with risperidone.
Primary diagnosis of schizophrenia.

Sponsors & Collaborators

Solvay Pharmaceuticals
Industrycollaborator
Wyeth is now a wholly owned subsidiary of Pfizer
Industrylead

Study Sites (66)

Little Rock, Arkansas, 72201, United States

Little Rock, Arkansas, 72211, United States

Anaheim, California, 92802, United States

Anaheim, California, 92804, United States

Anaheim, California, 92805, United States

Boynton Beach, California, 33426, United States

Costa Mesa, California, 92363, United States

MeSH Terms

Conditions

Schizophrenia

Interventions

bifeprunoxRisperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 21, 2006

Study Start

November 2006

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2008

Actual (reported)

Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

A

B

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (66)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations